Coating is an integral part of pharma tablet and pellet production. Nevertheless, there are some problem areas that have not been adequately solved so far, although they have an impact on almost every coating process and entail economic losses. To a certain extent, this is due to a presumed lack of possible solutions– but they do exist. In particular, a new generation of tablet coaters is addressing these challenges in an innovative way.

When talking about challenges in coating, there are basically three areas involved: the quality of the coating result, the productivity of the coating process and the flexibility of the tablet coater.

Quality 

Among the first things that come to mind when thinking about product quality is the prevention of defects. While the purely aesthetic defects can sometimes be tolerated, the entire batch is at risk if a functional coating is compromised. Preventing such losses is always a matter of stabilising the coating process by regularly checking parameters and adjusting them if necessary. The common method for increasing and simplifying this process control is currently to improve the technical feedback. After that, it is the operator’s responsibility to react accordingly. This is definitely a solution that works, but is it enough to achieve real process stability?

Reality is that this approach leaves a relatively large risk for errors and inaccuracies, because the regulation and optimisation of the coating process is absolutely dependent on the operator. What if there is no suitably skilled operator available due to the shortage of trained workers in the labour market or for other reasons? And even if a fitting operator is available, it is not always easy for him either to get the ideal coating settings and keep track of all the parameters, especially with batch size changes, complex coating processes or demanding products that are, for example, very sensitive to humidity or temperature.

The solution to this systemic uncertainty is to automate the coating process to a larger extent, including the fully automatic adjustment of the relevant parameters where required. The TP R Optima perforated coating pan from Romaco Tecpharm is capable of doing so. It monitors parameters such as temperature, humidity, flow rate and batch quantity, obtains the predefined optimal coating conditions for the specific product and thus minimises the risk of losing parts of or entire batches. One could say the TP R Optima tablet coater creates the absolutely reproducible coating process – irrespective of the complexity. The possibility of almost complete automation ensures that you no longer have to be an expert to achieve consistently high product quality with this technology. But what does this automatic self-regulation look like? This can be exemplified very well in the context of the second main problem area, where automation is also the means of choice for optimisation.

Productivity

The deficiencies in the productivity of the coating process are partly accepted as a given. As an example, it is currently common to plan for 50 per cent more suspension than is theoretically needed to coat a product, because a loss of up to 40 per cent is considered normal. With functional coatings, like coatings with API or controlled release coatings, this can result in major financial losses. But even with standard coatings there are hidden costs in the form of cleaning and disposal expenses, not to mention logistical expenses, because if more suspension is needed, more must be transported and stored.

Here, especially the automatic adjustment of the suspension application and drying is the answer. Technically, this is implemented in the TP R Optima as follows: Using sonar technology, acoustic wave sensors continuously measure the distance between the spray nozzles and the tablet bed, which may vary depending on the process that is conducted. If modifications are required regarding the ideal spray distance or the set spray angle, the intelligent system carries them out by means of a nozzle arm with a three-point extension mechanism during the ongoing process – the machine does not have to be paused for this purpose. Drying is regulated automatically via a vacuum generated inside the drum, which can vary depending on the batch size, and via automatic air exhaust flaps, which can be opened individually and continuously. This permits absolutely precise regulation of the path taken by the air flow through the tablet bed, ensuring that the coating does not simply run over the product before being discharged again unused. With these new possibilities of the coating technology from Romaco Tecpharm only 10 to 15 per cent more coating medium is needed instead of 40 per cent. And that makes a significant difference. The associated more efficient drying and the possibility to make adjustments without interrupting the coating process also reduce process times by hours. And prior to the actual coating, time is additionally saved in the fine-tuning and preparation of a new batch, as the TP R Optima virtually adjusts itself to the recipe and the associated parameters. All this combined results in substantially lower energy usage.

Another special feature of this technological adaptability is immense batch size variability within a single machine, which not only increases productivity, but above all brings flexibility– and that leads to the third main problem area.

Flexibility

Almost everyone who realises coatings has to deal with scale-up and scale-down procedures in some form or another sooner or later – for example:

– When producing for various countries and batch sizes have to be adapted to the different market requirements

– When validations have to be carried out and about 10 per cent of the subsequent batch sizes have to be manufactured for this purpose

– When producing under contract, where a wide range of batch sizes must be processed

– Or when the switch from laboratory to production scale is pending.

But why is scaling up and down a challenge? Firstly, it means that companies currently need at least two machines, one for producing smaller batch sizes and one for larger batch sizes, as most coaters do not have a large enough batch size variability. Usually, they can only go down to 40 per cent of the maximum batch size at the most. This need for several machines is associated with very high investment costs, energy expenditure and space requirements. In addition, the parameters cannot simply be transferred from one machine to another – not even if they are the same type and brand. Consequently, a relatively large number of manual adjustments have to be made, and here again the problem of ensuring high quality and uniformity across all products arises. Not to forget, of course, the time and work that goes hand in hand with manual adjustments.

With the ability to monitor and adjust to batch sizes, the TP R Optima achieves a batch size range from true 10 to 100 per cent filling volume with one and the same drum. This eliminates the need for multiple machines just because of different volume requirements, the time and manpower it takes to set up the right parameters for different systems and the risk of errors and imprecisions. What is more, this not only applies to validations and batches of different sizes, but also to volume changes within a single coating process, such as coatings with multiple layers. It could be argued that coaters with this range have been around for a while, and that is true, but the batch size variability of these technological solutions necessitated drum changes and manual adjustments, which removed the problem of purchasing multiple machines, but not the risks of manual intervention. Moreover, the drum changes created extra labor and cleaning efforts. This also becomes largely obsolete with the use of only one drum.

A final aspect of flexibility in coating is the possibility to change the coating medium itself without major technical alterations. There are several reasons why this could be required. For example, a reformulation may be a necessity due to imminent and acute bans on formulation components. Trends towards more natural ingredients such as the departure from alcohol in favour of water-based suspensions may also call for recipe modifications.

Again, automated parameter adjustment provides advantages. In the demanding search for new recipes, the experts can concentrate on the formulation and leave the rest to the machine. Apart from that, process times are shorter, which further facilitates R&D activities as more formulation trials can be implemented in a given period of time. Saving time is also the big issue with water-based suspensions, which have longer drying phases. Due to more efficient drying with the “full” automation of the TP R Optima, this does not have the same impact as with previous technologies.

Conclusion

There is significant optimisation potential in coating that can be exploited through a higher degree of automation. Shorter process times, continuously high product quality, time and cost savings and resource conservation are just some of the gains. Tablet coaters like the TP R Optima with these technological capabilities will certainly represent the future of coating and are already supporting innovation.

Contact

Sanjeev Nimkar

Romaco India

Unit No. 1005, 1006, 1007, Fenkin 9,

Plot no. C5, Road No. 9, Behind Satkar Grande Hotel

Wagle Industrial Estate, Thane (W) – 400604

Maharashtra, India

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In March 2020, Eppendorf AG and Koki Holdings reached an agreement that Eppendorf acquires Koki’s centrifuge business, including the premium Himac brand. Since July 1, 2020, Eppendorf Himac Technologies officially belongs to the Eppendorf Group. Since November 1, 2020, Eppendorf India has been able to offer the Himac centrifuges in India.

The acquisition marks a targeted step by Hamburg-based Eppendorf AG to expand its centrifuge business and solidifies its strong market position as a leading maker of high-end centrifuges for the pharma and life science industries as well as academic and commercial research.

Effective November 1, 2020, Eppendorf India has been able to offer an even broader range of centrifuges with the high-quality floor standing and high-speed centrifuges from Eppendorf Himac Technologies. With the new high-speed and large-volume floor-standing centrifuges, Eppendorf will be able to offer to all segments the right product. In addition, the modern Himac centrifuges offer a competitive advantage that customers value very highly.

“We are excited to acquire Koki’s centrifuge business and its premium Himac brand. These high-performance products are an ideal fit for Eppendorf’s centrifuges business and high-quality standards. With this acquisition, Eppendorf will become a full-line provider of high-performance premium centrifuges on a global level. This gives us access to new customer groups and offers opportunities for further growth.” The centrifuge business is one of Eppendorf’s core businesses, Fruhstorfer continued, which will be sustainably strengthened by the acquisition,” Dr Peter Fruhstorfer, Co-CEO of Eppendorf AG.

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Rockwell Automation recently released the PlantPAx 5.0 distributed control system (DCS). This latest DCS version from Rockwell Automation helps industrial producers positively impact the lifecycle of their plant operations with plant-wide and scalable systems to drive digital transformation and operational excellence.

“New system capabilities help digitally transform operations by introducing process functionality native to the controller, improving the availability of system assets driving compliance in regulated industries, while enabling the adoption of analytics at all levels of the enterprise. Intuitive workflows and the use of industry-leading cybersecurity standards will help teams design, deploy, and support a DCS infrastructure which reduces time-to-market and helps plants realise profit at a faster rate,” informed the company through a statement.

“We’re excited to bring PlantPAx DCS 5.0 to our customers. New system features are step changes in helping our customers lower the overall costs to design and commission. The functionality improves the overall effort to integrate the process control layer to the enterprise. By reducing the lifecycle cost of the system and lowering operational risks, we are continuing to find innovative ways to bring more value to end-users,” said Jim Winter, Global Process Director, Rockwell Automation.

The company also informed that process end users desire a system that offers the benefits of a modern experience without the burdens that come with a traditional DCS. Therefore, the new 5.0 release innovates the modern DCS in the following areas:

• Reduced footprint
• • This release introduces new process controllers and extends the Logix family with cutting-edge processing power and capacity to reduce the complexity of PlantPAx architectures. This footprint reduction reduces total cost of ownership of the system throughout the lifecycle.
• Project consistency
  • With native process instructions embedded in the controller firmware, project teams can adopt approaches to control strategies that drive consistency for individual projects or multi-site deployments. Consistency simplifies the lifecycle management of deployed systems as teams modernise their automation infrastructure. Consistency lowers total cost of ownership (TCO).
• Streamlined workflows
  • PlantPAx 5.0 provides improved design and operational user experiences. Development teams will realize savings in the configuration of instrumentation, alarms and diagnostic system elements. Operators will have the extended ability to view underlying control logic in a safe and secured manner. Maintenance will have controlled view access for troubleshooting.

• TÜV-certified for cybersecurity
  • To operate at peak performance and minimise cybersecurity threats, PlantPAx 5.0 system architectures are TÜV certified to the international standard ISA-99/IEC 62443-3-3 which provides guidance on the implementation of an electronically secured system.

• Analytics enabled
  • Process end-users recognise the value of analytics as an essential strategy to realise profit in their process operations. The PlantPAx 5.0 release has purpose-built frameworks that easily connect live and historical data from the DCS into reporting and analytical tools.
  • Enables extended experiences, such as Augmented Reality, using workflows aligned with process strategies controlling plant operations.
  • Allows extensible scalable analytic packages leveraging predictive and prescriptive models for process applications such as soft sensors, anomaly detection, or model predictive control.

As producers continue their digital transformation journey, the advances from this system release will help them unlock value and reduce overall costs at all phases of the plant lifecycle, assures Rockwell Automation.

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The pharma industry raised the issues related to the implementation process of Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) scheme, in a recently held DoP meeting with industry stakeholders. Although the scheme was announced in 2014, the industry is yet to avail the scheme benefits. Therefore, in this meeting chaired by Dr PD Vaghela, Secretary, DoP, industry representatives requested the Department of Pharmaceuticals (DoP) to expedite the implementation process of PTUAS and made some recommendations.

Mahesh Doshi, President, IDMA informed, “During the recently held meeting, we requested the authority to expedite the implementation process of PTUAS for the benefit of the pharmaceutical industry in India. We have also made some suggestions to the authority in the existing scheme like; the maximum loan eligibility criteria for availing the scheme should be increased from Rs 4 crores to Rs 10 crores and they should de-link the export criteria for the scheme because the present outline of the scheme requires export to be achieved equal to the loan amount. We are hopeful that the authority takes our recommendations into consideration for the growth of the industry.”

Amit Chawla, Secretary, MP- Small Scale Drug Manufacturers Association said, “We seek support from both, the Central Government as well as State FDA authorities, in rolling out PTUAS in the country. The scheme needs attention to create awareness programmes about explaining the possible benefits of upgrading technology. This can be initiated by the MSMEs and explained by the pharma allied industry. Product specifications can be explained by them which will help manufacturers to enhance the productivity of the final output in terms of time, energy and working capital.”

He continued, “In my opinion, on a priority basis, the central government should appoint SIDBI as an implementing authority to expedite the process, as documentation takes a long time. However, to address issues like unavailability of a SIDBI branch to a specific city, the lead bankers of these cities can be designated as the lead banker authority. If this scheme becomes operational then we see all the players, small, medium and big, getting benefitted from the PTUAS.”

Nipun Jain, Chairman, Small and Medium Pharma Manufacturers Association expressed, “Although the PTUAS scheme was announced a couple of years ago, the Ministry is yet to appoint a lead banker who will act as a facilitator to the industry in availing the scheme benefits.”

He also pointed out that the central government announced PLI scheme is a good move towards making Indian pharma industry self-reliant,  however, PTUAS does not have any investment restriction therefore it will benefit all the players. “Taking into consideration these aspects, we urge to the government authorities to expedite the implementation process for the benefit of the sector as well as the country,” he said

Vinod Kalani, President, Rajasthan Pharmaceutical Manufacturers Association, (Jaipur) said, “The central government announced PTUAS is a good scheme and it should be implemented on a priority. It will certainly help the MSME pharma companies to upgrade their plant and machinery systems, automation, quality assurance/ quality compliance activities etc. as defined and required in the WHO-GMP guidelines. This will boost and enhance even the formulation research and development activities in the country in the MSME segment. And the outcome of the scheme will be seen in a shorter period as against other announced schemes.”

What is the scheme about?

Explaining how the plan came about, Vinod Arora, Ex VP Ranbaxy, Principal Advisor – IGMPI informed, “There was a meeting at the Ministry of Health and Family Welfare, Government of India, Nirman Bhawan office a few years back wherein the gap between the WHO GMP and Schedule M of Drugs & Cosmetic Act & Rules were discussed including how frequently they are updated etc.  And post the meeting, the review of the gaps with senior members were discussed and an action plan was worked out with an objective of strengthening the existing infrastructure facilities in order to make Indian pharma industry a global leader in the pharma sector.”

The objective of PTUAS is to facilitate Small and Medium Pharma Enterprises (SMEs) to upgrade their plant and machinery according to the World Health Organization (WHO)/Good Manufacturing Practices (GMP) standards, so to enable them to participate and compete in global markets.

Assistance in the form of interest subvention against the sanctioned loan by any scheduled commercial bank/financial institution, both in the public and private sector will be provided to pharma SMEs based on their proven track record. The scheme is to be implemented through a Public Sector Financial Institution (PSFI), which is yet to be identified by the Government.

As per the scheme, the upper limit of interest subvention on loans for technology/infrastructure up-gradation has been restricted to six per cent per annum for a period of three years on reducing balance basis. The maximum loan eligible for this purpose will be Rs four crore, which can be availed by the concerned SME. A total of Rs 144 crore has been earmarked for the scheme. All beneficiary pharma SMEs to whom benefit of interest subvention to be extended must obtain WHO GMP certification in two and half years from the date of the first disbursement. In addition, the pharma SMEs under this scheme need to ensure that they achieve incremental export revenue in excess of the sanctioned loan amount within 36 months of the last draw of the loan failing which the loan will be converted to a normal one. There will be a midterm review after completion of one year.

usha.express@gmail.com
u.sharma@expressindia.com

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World Clinical Trials Day, May 20, marks the date of the first randomised clinical trial, held aboard a ship in 1747. Today, as part of biopharmacetuical R&D, clinical trials is the area where the spend is the highest and provides the most opportunity for automation and adoption of artificial intelligence (AI). Sowmyanarayan Srinivasan, Managing Director – Life Sciences, Accenture Advanced Technology Centers in India (ATCI) predicts that the future of clinical trials will be fully AI-enabled, starting right from protocol to clinical operations around site and investigator management and eventually pivoting to patients and making it easier for the patients to be part of clinical trials

The global biopharma industry is undergoing significant transformation across the spectrum of drugs, drug delivery and business model. There is an increasing focus on patient at the core. Some of the key drivers of the transformation are –

• End of blockbuster era and beginning of niche buster era. The drugs are getting more personalised and relevant for much smaller populations. This also means that the number of drug launches are increasing
• Focus on new science driving more companion and digital solutions as approved drugs, genomics is driving personalised drugs
• Healthcare consumerisation is being driven by the digital revolution. Patients do not want to be held back by disease and want to be treated more like consumers. They are looking for same experiences as in their daily lives, for example retail
• In North America and Europe, the focus on outcomes has increased and reimbursements are tied to defined and agreed outcomes

According to a recent report (1), while the transformation is driving a change in pricing models and patient engagement, the costs of bringing a drug to the market continues to increase and is projected to be worth $2 billion. This situation has created a perfect storm to reimagine the entire biopharma R&D process which is the main cost contributor in getting the drug to the market.

As biopharma organisations focus on reimagining the R&D process, one of the key enablers of this change is Artificial Intelligence (AI). Though AI has existed for several years (in fact decades), the adoption in the biopharma industry was slow and has increased significantly in the last six to eight years. This adoption can be directly attributed to increased generation and availability of data, ‘big data.’ There has been a tremendous increase in both volume and variety of data – genomics data becoming mainstream and cost effective, imaging data and the ability to store and analyse such data, patient data from digital solutions and patient medical data with higher adoption of EMR and EHR. In this evolution, the bottleneck moved from quantity of data to quality of data and curation, though the fact that data is available for leveraging artificial intelligence techniques is a critical factor for increase in adoption.

Reimagining R&D

If you look at the history (2) of clinical trials, the first clinical trial of a novel therapy was accidentally conducted in 1537 and it took over 200 years (year 1747) to the first controlled clinical trials and another 200 years (year 1946) to the first double-blinded-controlled trials, which has been the norm since that time. It clearly shows us that scientific establishments take a long time to change and modernise processes. However, if you consider technology evolution in the same timeframe, for instance, it has grown by leaps and bounds. Today, we are at a point where there is a need to get medicines to the market faster and there are several technologies that are available to help the overall R&D, specifically clinical trials to leapfrog many challenges.

While clinical trials is an obvious place to start given the disproportionate amount of spends, the future of R&D will not only have a different approach for research, but to safety and regulatory as well. Let us start by looking at potential use cases in R&D and how they can drive transformation in R&D.

Potential use cases in R&D

The first step to reimagine the R&D process is to identify use cases which are ready and mature to be adopted for AI. The primary drivers for this would be quality and quantity of data and predictability of the use case. Some of the most common use cases across research, clinical, safety and regulatory are outlined in the next sections.

Summary view of potential use cases

Research reimagined

Science is evolving rapidly, and it is humanly impossible to track these changes. Research is hypothesis-driven and is amenable to using AI. In fact, use of AI in research has existed for a very long time. The earliest set of databases, be it for compound, target or pathways, used AI and curation to build and deliver at scale.

Some of the use cases in research that are already in play are as follows:
1. Next Generation Sequencing or genetics and genomics data in general – This has been at the heart of big data for biopharma. Requires multiple steps to run the analysis to get to relevant insights around disease target or biomarkers.
2. Pharmacokinetics (PK)/ Pharmacodynamics (PD) Modeling – It has been in existence for very long. There are well-known products in the market that support this and is commonly used and adopted.
3. Target, compound profiling – There are companies that are focussed on building this as a product by leveraging AI and then curating to ensure high-quality data.
4. Pathways – AI plays a key role in extracting entity interactions from publications / other data sources which become the base for pathway building.

There are industry-leading solutions in this area which have been around for long and are well-accepted solutions. The continuing challenge in research has been around bringing data together, drive standardisation and leverage analytics to enable business decisions. The next horizon in research is data platforms that will enable broader AI and analytics to reduce overall cost of lab experiments and support rapid hypothesis testing.

Clinical trials reimagined

Clinical trials and research is the area where the spend is the highest and provides the most opportunity for automation and adoption of AI. Some of the main challenges in clinical trials are around patients, site, investigators and collaboration.
Patient identification and recruitment continues to be a challenge as the number of trials and studies continue to increase. Several of them are in the same therapeutic area with similar disease and target focus. This means that the target population for several companies is the same and success in getting to patients is limited. This is compounded by the fact that less than five per cent of the patients opt to participate in clinical trials.

While recruitment is key, patient engagement is also important. Although the first steps are to identify and recruit patients, the industry also struggles to retain patients for the duration of the trials. Patient drop out is a big ongoing challenge in clinical trials. On the other side, site or investigator selection is a critical part of trials success. As drugs become more specialised and targeted, the expertise for managing trials have also increased. Finally, lack of clinical stakeholder collaboration is also a challenge. It is important to bring together the various stakeholders on a common platform which is a critical success factor for trials completion on time. There are several opportunities that are fit for driving transformation in clinical trials.

The clinical process starts with a protocol document which outlines the approach and intent of the clinical study. The key content of this protocol document then needs to be used to set up an electronic data capture system that will help capture defined data of patients as outlined in the protocol during the various visits to the site. Today, the process of setting up the electronic data capture system from the protocol takes anywhere between 12-16 weeks since the process is completely manual. The data entry and quality-check iteration time take the bulk of this total time. The future of this process will be AI-driven, where AI will learn from past protocols and provide suggestions as new protocols are drafted. It will support data extraction from the protocol to load into the electronic data capture system and increase productivity by 80-90 per cent which will provide significant competitive advantage.

Today, there are some opportunities especially in the clinical operations area that have adopted AI to varying degree while there are several others that are ripe for disruption. Identifying the right patients and retaining them along with right sites and investigators is predominantly AI-driven and will continue to be dominated by AI, given the large pool of data available.

• Patient recruitment helps identify the right set of patients for a given study by using data across past studies, EHR/EMR, other data sources like patient communities based on data access
• Patient adherence and drop out is based on patient behaviours like medication adherence, diet, fitness regimen, ongoing health record etc., predict patients that are at risk of not complying with the requirements of the clinical trial or dropping out of it completely
• Site selection helps profile sites based on therapeutic area across various parameters like ability to recruit patients on time, data quality, training etc.
• Investigator selection/profiling helps profile investigator performance specific to therapeutic area leveraging proprietary data, commercial data and public data like publications/clinical trials disclosure sites etc.

In addition, Automated Clinical Study Report (CSR) generation, AI/ML-enabled CSR generation based on available data, are some of the other areas to benefit from AI. As one can clearly predict, the future of clinical will be fully AI-enabled starting right from protocol to clinical operations around site and investigator management and eventually pivoting to patients and making it easier for the patients to be part of clinical trials.

Some of the start-ups that are seeing success in driving adoption of AI in clinical include:

• Deep 6 AI:- Trial matching software can find eligible patients for complex trials within minutes
• Viz.ai: It helps analyse CT scans to identify potential stroke.
• AiCure: It helps improve medication adherence by visually confirming medication ingestion.
• Trials.ai: In its first trial, AI retained 98 per cent of patients, had one critical deviation throughout the entire trial, and continued to completion without interruptions.
• Several biopharma companies are focussed on setting up control room like centres for monitoring clinical operations and interacting with sites real time.

Patient safety reimagined

As the pharma industry pivots to patients, their safety has become the key differentiator to drive success in the market. An increased focus on safety implies an additional cost burden which adds to the ever-increasing cost of bringing drugs to the market. Pharmacovigilance (PV) is the process of monitoring/managing drug/patient safety.

For instance, focus on drug safety is being driven by many parameters. As patients become more aware, there has been a surge in safety data volumes and the number of reported cases is increasing steadily. The regulatory authorities across the world are becoming more stringent and the regulations continue to evolve, which in turn again drives increase in reported events. Further, with digitisation taking center stage, there is an increased proliferation of social media usage and patients/consumers reporting potential adverse events in these forums, thereby increasing the burden on biopharma companies.

These trends together put an undue pressure on biopharma companies to increase their spends on adverse event processing. However, AI has started to play a crucial role leading to several use cases , where it has showcased  reduction in time and effort required  to process adverse events.

Below are some of the key use cases in safety which are being adopted by biopharma companies globally:

• Literature scanning to support the mandatory requirement to scan literature in regular intervals to look for adverse events. AI makes this search simpler and easier.
• Proactive signal analytics to continuously look for potential signals which can cause significant harm to patients and proactively address by label changes or changing target patient population, etc.
• Case intake and processing leveraging AI for case intake across both structured forms like CIOMS or unstructured sources like publications, patient support programmes etc. This will be the game changer.
• PV social listening to monitor social/digital media, AI can help monitor for adverse events. While the guidelines are broad, this is a best practice that can at least help alert for any real adverse events in the social forums.

The future of PV will have an integrated AI approach – today an adverse event processing can take place anywhere between several hours to days, and this can be reduced dramatically to a few to several hours by leveraging AI for case intake and processing, with humans reviewing the results and approving the submission. Increasing data will mean better signal detection and improved algorithms will help drive better outcomes.

Regulatory reimagined

Regulatory was the last to start adopting technology solutions and start the transformation journey from manual processes, emails and excels to newly evolving focussed platform solutions. As the market becomes hyper competitive and crowded in specific therapeutic areas, it is extremely critical to get the submissions right the first time. The key challenges that need to be addressed to achieve this mission are keeping track of changing regulatory requirements which continues to evolve – as newer forms of drugs hit the market, new science resulting in several companion digital solutions with additional requirements, collaboration and coordination with local markets for region specific requirements and the inability to qualify submissions based on past experiences and interactions with regulatory authorities.

The challenges nicely lead to several opportunities where AI can play a role in solving them. Here are few opportunities that can directly address immediate needs:

• An AI-driven regulatory intelligence engine tracks changes in regulatory requirements. It is designed as an intelligent engine to track changes in submission requirements for regulatory agencies with digital presence. It will alert significant changes to avoid delays during the submission process.
• One of the significant and critical AI solution is Health Authority Interaction Mining/Intelligent Submissions. This intelligent engine will mine past health authority interactions to enable response to new queries. This can also be forward looking to act as a filter to avoid any aspects that may lead to queries from health authorities.
• When it comes to actual submissions, the AI engine that will drive the future will be automated regulatory submission for dossier compilation. This will be an AI/ML enabled data and document collection based on the specific country/geography specific regulations and preparing a dossier ready for submission and in some cases e-submission to select authorities. This will enable automated conversion of unstructured data/documents to a structured format, based on pre-defined configurations per country/geography specific regulations and AI/ML-enabled data extraction and data entry into regulatory portal for e-submission.
• Finally, an automated label creation solution based on AI/ML-enabled label creation based on master specifications pre-configured on brand category per regulations of country/geography.

This holistic regulatory solution suite based on AI will dramatically improve the functioning of regulatory team and help them focus on the launch planning with laser focus. The solution suite will provide biopharma companies with competitive advantage and help them get to market faster.

Getting ready for NOW

Biopharma companies are in the middle of a major change and one of the important drivers for success would be people. The future is bringing AI and people together to derive key insights and drive rapid decision making. The success of biopharma companies will depend on getting their people ready for the present as AI becomes mainstream. While AI can bring the art of the possible, the decision-making will still be driven by humans. Training and upskilling the workforce will be a major focus in the immediate future to ensure we are ready to deliver in the reimagined world of biopharma R&D. Some repetitive tasks will be eliminated, but more complex decisions with new science will be there where the humans will have a major role to play.

How to get started

It is evident that AI has become mainstream and will have a major role to play in reimagining the biopharma R&D process. With increasing pressure on cost, need to establish outcomes-based models, shift from volume to value, and most importantly putting the patient at the core, it is obvious that biopharma companies will need a dramatic change to the current processes to drive innovation and stay competitive. With increasing availability of data, data-driven approaches will take center stage and companies that will succeed are the ones that can get the most out of this data and AI will be at the heart of driving this transformation.

The very first step in getting started is to do an internal assessment on the current state across the R&D functions. The output of the assessment should be a maturity index for each of the R&D function in terms of leading or lagging. A blueprint should then be created for each of the functions on way forward with clearly outlined success criteria. The blueprint should call out specific use cases, technology solutions, data access and veracity and anticipated challenges. The use cases outlined in this point of view are a good starting point to assess. Finally, translating the blueprint into an execution roadmap and following through to closure will be critical in getting ready for the future and positioning for growth and success.

References
1. https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/
2.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/

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Offering sustainable solutions is not limited to any project but with connected thinking of Mott MacDonald team and client. Vipul Patel, Chief Engineer-Piping, Energy, Mott Macdonald India, gives an insight on the same

Our core aim is to make a sustainable difference to the world we live in. That translates into a focus on understanding our clients and their customers, to deliver outcomes that add value. The value-added design inputs and their impacts on Mott
MacDonald’s projects always tend to address, directly or indirectly, some of the United Nations Sustainable Development Goals (UNSDG).

Methodology

Offering sustainable solutions is not limited to any project but with connected thinking of Mott MacDonald team and client, long-lasting, value-added ideas can be generated for almost all or any type of  projects that may come across.By the optimum engineering design of many of our industrial projects, we have imparted high contributions towards sustainability. From very basic engineering stage of any project, we seek ways for maximising sustainable outcomes for the environment, industry and the client.

Process

Always seeking opportunities for innovations, improvements and out-of-the-box thinking for creating value for our clients. We work with our clients to create value by saving time and cost by optimising process performance, reducing cycle time and thus increasing output within same set-up of industrial equipment and environment. Savings of every tonnage of steel, concrete means substantial saving in energy, water, CO2 emission, space etc. Use of emerging technology in energy efficiency, schedule improvement has great effect in sustainability solutions.

A pharma case study

While engaging with an upcoming pharma project’s team and learning about their priorities and focus on sustainability, Mott MacDonald provided some value-added solutions specially designed for them as under:

• Provision of solar panels on the roof of plant: Around 800 kwh power generation has been envisaged while designing the panel on the roof of main plant as per available area.
• Implementation of a Common Building concept: During the conceptual design stage, Mott MacDonald suggested one common building for plan which should encompass plant area, admin area, utility area, control room, MCC panel area, cooling tower on the top of terrace, DG set and transformer. Overall, space requirement and construction area was reduced.
• Installation of cooling tower on plant terrace: The cooling tower, along with ancillaries such as pumps, dosing chemicals, side steam filter, etc. were located on the terrace. This resulted in substantial reduction of piping and electrical cabling network. Additionally, there was an increase in the thermal efficiency of cooling tower due to open location and power saving due to lesser pressure drops.
• Rain water harvesting: During the design stage, it was suggested to collect rain water from the plant roof providing a close network. The water stored in the tank was utilised for raw water and fire water as and when required. This resulted into less requirement of underground water (natural reserves) thus reducing bore well pump usage saving power costs.
• Recovery of reclaimed water from ETP:  Reclaimed filtrate water from ETP shall be utilised for toilet flushing as well as gardening / afforestation in Green Belt Area.
• Installation of VAM (Vapour Absorption Machine) for generation of chilled water: Utilisation of excess steam (during fluctuating demands) for generating chilled water through VAM instead of VCM (Vapour Compression Machine) to save on power costs.
• Installation of non-metallic pipes:  Wherever possible, non-metallic pipes were utilised which contributed to lesser material and labour cost.
• Pre-fabricated roof of PEB (Pre-Engineered Building) in place of RCC slab: By providing PEB roof shed in place of conventional RCC slab, substantial construction time was reduced along with lesser quantity requirement of steel, cement and concrete.
• Locating utility equipment on ideal location within plant: Central location of all utility units (such as chiller units, air compressor, VAM, dryer – all along with connected pumps) to reduce piping and cabling network. This reduced system piping pressure drops resulted into lower pipe size requirement. This also resulted into life-time power saving of transfer pumps.
• Utilisation of space on water tank RCC Slab: The entire WTP plant and worker’s canteen were located on the top slab of underground water storage tank. This resulted into optimum utilisation of plant space requirement.

Benefits to industry

• Reduced carbon footprint.
• Lesser capital consumption due to less material usage.
• Judicious use of land area (as resource) management and durable infrastructure.
• Reduced life cycle cost by less consumption of energy resource.
• Capital saved can beinvested further resulting into additional economic development.

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Presenting Japanese technology at Indian cost is the main aim of the joint venture between Tokyo-based Freund Corporation and Mumbai-based Parle Global Technologies. Iwao Fusejima, President & CEO, Freund Corporation and Mahendra Mehta, Managing Director, Parle Global Technologies spoke to Viveka Roychowdhury on the sidelines of the launch of the first product from this JV

Congratulations on the joint venture (JV) between Parle Global and Freund which was announced in December. When and how did the talks for this JV start?

Iwao Fusejima: It took us five years. We met in 2013 when Parle Global found us in Europe at ACHEMA exhibition. After I talked to him, I felt we shared the same values with the Mehta family. My father started Freund Corporation in 1964. Similarly, Parle Global Technologies was set up by Mahendra Mehta’s father,  Rajmal Mehta and when I met his father, he was like my father. Both have had the same entrepreneurial drive and at about the same age. Though he is Indian and I am Japanese, I really felt that we have the same values. I think having the same values from the get-go is the best starting point. It still took us five years to come to this point of announcing this JV.

What kind of a partner was Parle Global looking out for? Are there other JVs, partnerships?

Mahendra Mehta: We started our company in 1974, as a tablet tooling manufacturer, making dies and punches for tablet compression machines (tablet presses). We also were representing many companies from Korea, Japan, US, Germany; bringing their technologies to India as sales and services agents. When we saw Freund’s product at ACHEMA in 2013, we found it to be a good technology. We felt Indian pharma customers were now ready to go up a level. They were managing with locally available technology, and then imported technology from Korea and Italy, but they were now looking for technologies from Germany and Japan as these were at another level. We found the Freund product very efficient. Although it is expensive, we knew that Indian pharma companies are now ready for the next level and would find it affordable because they believe in quality and were moving from semi-regulated markets to more regulated markets.

We approached Freund with a proposition to sell their equipment in India and started selling their products five years back.

After four years of sales partnership, about a year ago, we informed them that some of their products were not convenient to sell from Japan, because of cost compulsions. Manufacturing cost in Japan, where  labour cost is high and then shipping the product, when technologies have already developed over the years. So, we requested them to evaluate manufacturing these in India under the Make in India programme. We have a couple of JVs with companies from the US and Korea. (Parle Elizabeth is a JV formed in 2008 between Parle Global Technologies India and Elizabeth Carbide Die, US.) We were able to give these examples as proof that if these technologies were brought to India and manufactured here, we might be able to achieve good cost benefits without compromising on the quality as the design remains from Japan. They agreed to try out this experiment and sent us all the core parts from Japan and we started looking at how to manufacture the machine here. The roller compactor is the first product made this way which we introduced to the market and launched at the CPhI India show in December.

How is this roller compactor different from the one made in Japan?

Fusejima: There is no change, it is basically the same.

Mehta: That is what is different about this JV compared to other European JVs. The technology generally coming to India is not the same as that launched in European countries. They launch technologies which are becoming obsolete so that they do not feel threatened if it is made in India. Whereas when we spoke to Freund, they said we cannot have two different qualities. The one made in Japan must be the same as made in India. We thought it’s good, because we would like to offer the best technology to our customers, not something that is five or 10 years old.

How is it different from a similar technology from your competitors? What is the value proposition that is being pitched to customers for this product?

Fusejima: Firstly, we have 54 years of experience. Secondly, our strength is that Freund is not just an equipment manufacturing company. We also deal with excipients and chemicals technologies. We call this hard and soft technologies. That makes us unique in the market. The most important part of the success of this JV is to have a place to demonstrate this in India. We have R&D and testing centres in Japan, the US and Italy and now we have one in India as well, through our JV with Parle Global Technologies. Most customers in India had to come to Japan, the US or Italy but now they can just go to the Parle Global facility office to test our machine. This JV also leads to better after sales support, and training to the staff of the customer on the use of the technologies and machines.

In terms of price, does making it in India, result in a more affordable product? Can the Indian pharma SMEs also consider buying such technologies directly? Even though today they may be tapping the semi regulated or non-regulated markets?

Mehta: As of now, we were selling the Freund equipment only to those companies catering to regulated markets. But SMEs represent a big percentage of the market in India. SME companies investing in new projects were finding it difficult to send their material to Japan, or the US and other regulated markets for testing etc, due to regulation issues. This JV gives them an opportunity to use this equipment in their plant. They can at least develop the product in the laboratory available here, even if they decide to use another equipment for manufacturing it. They will be exposed to a better technology to make a very efficient process at the development level. More than the product, Freund makes the process.

Some companies’ equipment might take 14 hours for the granulation process while the Freund equipment could do it in just four hours. There could be that big a difference. Plus, there is a lot of material handling involved, sieving, etc. These are benefits which cannot be shown on paper but can be seen only while experimenting on the equipment. They can see the quality of product produced, plus the savings in terms of time and material, achieved with such technologies, which will have a direct benefit to them in terms of money.

Whenever a customer has come to our plant with a trial product, they are much more convinced with the quality and ready to bear the cost for the value that we are giving them. So, SMEs will be benefited. The bigger companies are already importing from Europe or Japan and might continue doing that from our principals.

If the same technologies are available in India, why would companies decide to continue to import?

Mehta: If the product is for a regulated market like for instance the US, companies do not want to change any of the specifications in the registrations at existing manufacturing facilities. The cost of the equipment is not a major worry for them. Therefore, we are targeting new projects.

What about the intellectual property like design patents associated with this technology and product?

Fusejima: We have a subsidiary in the US. Although the core technology and product are from Japan, they have done some tweaking and changes for their customers. The same would apply in India. We are going to be flexible as far as the design goes. If something needs to be changed for Indian pharma customers, so be it and they just need to let us know about the changes being made. The most important thing is what the customer needs.

What are the financial implications and how is the JV structured?

Mehta: It’s a new entity created as a JV with 51 per cent equity investment from Freund and 49 per cent from Parle Global. Freund is a public listed company, and this becomes its subsidiary in India, like their existing subsidiaries in the US and Italy.

What has been the response to the launch in terms of inquiries, orders from customers?

Mehta: The Japanese concept of manufacturing is that they will launch a product only if they are confident of it. Their engineers came and ran the machine made in India through trials, spent a good time testing the machines thoroughly before allowing it to be offered for sale at P-MEC/CPhI India show. We started taking inquiries and making offers at the show. A few of our customers are always waiting for new technology launches from Parle based on the last 45 years of their experience with us. So, we did have a couple of customers who walked into our stall and expressed an interest to buy it.

This is a unique product, the first in this range, with Japanese technology available at an Indian cost. It will be a good proposition to the market. Granulation has traditionally been a wet granulation, but dry granulation is picking up. Directly compacting the material through dry granulation is picking up because now we have the technology to support this need. The industry was always looking for something more efficient but there was no equipment to support them. Now, we have technologies available from the Europe, the US and Japan to support development of the product through dry compaction. We are happy to be the first ones to launch this technology as a JV product in the India market. The same technology is available in India as well as from Europe through agents, but this is the first such product through a JV made in India.

Just as dry granulation is picking up, what are the other trends that you see in the coming year?

Mehta: Globally, the pharma sector is continuously challenging engineers for solutions. They are faced with issues like counterfeits and material wastage. They want to have a track and trace system so that they can trace their products even up to the last stage of distribution. They want to offer combination drugs so that the patient does not have to take three to four tablets but a single one with its name in eligible print on it so that the name is not just on the foil or bottle, but also on the tablet itself. If possible, even a bar code that can be scanned. We keep working on such inquiries. Freund has been working on printing machines as well as process equipment to improve the efficiencies and save time. Parle Global has tablet compression machines which can make two/three layered tablets as well as tablets within a tablet. These are the innovations we are working on.

Do these inquiries from customers in India have similarities with those that you get from your customers in other parts of the world?

Fusejima: Yes, the trends and inquiries are similar now. There used to be a difference between the US, Europe, Japan and other countries but not anymore.

Mehta: The pharma industry is today globally at a similar level. Major markets are the US, Europe and Japan. All the technologies required are the same. Today, we have so much of knowledge sharing in the industry, with people from across the globe coming to India and sharing their experiences and expectations. As an industry, we are now exposed to a lot of technologies and options which is helping all of us.

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As pharma companies in India strive to tap opportunities in large emerging markets, lean manufacturing techniques will play a major role in enhancing profitability and compliance. Sajiv Nath, MD, Yokogawa India tells Viveka Roychowdhury that automation is the first step towards achieving improvement in compliance, which is why they are seeing increased traction from the pharma sector since last couple of years

As a provider of industrial automation and test and measurement solutions, which sectors/industries form the bulk of Yokogawa’s global revenues?

Envision a pharmaceutical plant where people are watchful and attentive as the business responds to change quickly and efficiently. As digital transformation ensues to disrupt, transform and reshape industries, we can now picture an operation that delivers consistent production, real-time information and accurately controlled and safe processes that comply to the regulatory and demanding requirements of the pharma industry.

The pharma industry has recognised the value of automation as we have come to recognise that industrial automation is a business tool, not just a control tool, which can help process businesses meet their industrial challenge. It is imperative for pharma companies to achieve compliance and safety while maintaining cost efficiency as any deviation in the set standards can lead in jeopardising the lives of the end users.

Ideally an intelligent and scalable Plant Information Management System is in the heart of the system which  provides an analysis and reporting application that collects, stores and displays current and historical data from batch production, equipment and recipe viewpoints. This enables production and recipe management, process engineering, quality management and operations staff to easily access batch information for decision support, production planning and scheduling, analysis, process improvement and quality purposes. These are  ideal productivity improvement tools that enables user to focus on KPIs (Key Performance Indicators) such as a cycle time and frequency using the web based browsing, analysis and reporting user interface and to develop action plans for process improvements. Intelligence and scalability varies from developer to developer and user needs to exercise right diligence to select the one suitable for present and as well future needs.

Yokogawa’s global revenues come from various segments, viz, pharma, oil & gas, chemicals, power, iron and steel, pulp and paper, foods and beverages. Yokogawa spans across 60 countries, sales exceeding $3 billion, has more than 4500 patents and registrations, 18 manufacturing facilities, dedicates 6 per cent  annual revenue towards research and development and is the world’s first distributed control system and digital sensors.  We have state-of-the-art staging facility for distribution control system in Bengaluru which is spread across 15000 sq ft area and a local manufacturing facility under the ‘Make In India’ slogan. The factory is the mirror image of our facility at Yokogawa’s Kofu factory in Japan.

Which are the sectors served in India? How much percentage comes from the pharma sector?

Yokogawa has developed sustainability goals that will guide its efforts to make the world a better place for future generations. To ensure flexible response to environmental and technology changes and guide its long-term efforts to address social issues. Yokogawa is committing itself to the achievements of goals that are based on a vision of where our society should be by the year 2050. We will work to achieve net-zero emissions, take a transition to a circular economy and pharma companies operate in a global marketplace and the industry is encouraged to comply with international initiatives such as the PIC/S Good Manufacturing Practice (GMP) Guide and the ICH Guidelines. GMP facilities need to follow established best practices and automated production equipment and computer systems are expected to adopt current computerised system validation (CSV) practices such as Good Automated Manufacturing Practice (GAMP). As a company our goal is to contribute to society through broad-ranging activities in the areas of measurement, control and information. Individually, we aim to combine good ctitizen with the courage of innovation. Automation of processes and embedding rules helps companies in ensuring that the data produced is compliant. It can be thus concluded that automation is the first step towards achieving improvement in compliance from the regulatory point of view. Contribution from pharma industry is seeing a high growth rate since last couple of years. With innovative IIoT solutions, inherent reliability and quality –hallmark of Yokogawa and synonymous with pharma undustries , we are poised for higher growth in this segment.

As profit margins continue to decline, pharma companies are forced to look for ways to cut cost. How can Yokogawa help them cut costs without compromising on quality, given that regulatory strictures are only rising by the day?

The automation of data knowledge insights is an area of focus in the immediate future. In order to get to this stage of maturity, we find that majority of the organisations are significantly unprepared to be data driven. Often, customers replace existing big data technologies and the culture has not yet transformed to leverage data as a critical digital asset. Some of the other critical issues in transforming an organisation to become data driven include organisational alignment on analytics, overcoming existing master data issues, recruit new talent (data scientists, machine learning experts) and best-in-class data governance practices. In essence, organisations should leverage data as a pathway to drive operational efficiency, growth and sustained operational value improvements.

Both compliance and regulation are required while manufacturing the products and packaging them. In today’s new age IIoT age process automation system is applied in the primary manufacturing of the active pharma ingredients and process and discrete automation techniques are applied during packaging and formulation — which include compounding, washing, labelling machine, and packing.

Pharma companies can look for-

• Secure flexible reporting incorporating data from batches, master recipes, equipment, trend values, alarms and events.
• Built-in reporting workflow to configure templates, approve templates, assign to report scheduler, run templates to  generate reports, approve reports and view reports.
• 21 CFR Part 11 capable option is available, if required.

Big Data, the Industrial Internet of Things (IIotT), AI, machine-to-machine (M2M) learning etc are buzz words in this data-driven era. How is Yokogawa helping pharma companies leverage this data to enhance productivity?

For emerging technologies in pharma segment, choosing the right solution is always a challenge. So best way to depend on the leaders known for technological innovation, customer centricity and reliability. Here are few guidelines:

1. ‘Out of the box’ integration with batch control systems, providing immediate usability and benefits without complex engineering and database configuration.

2. Standard data analysis capability, providing:

• Automatic calculation and charting of cycle times and unit utilisation for each batch.
• Automatically calculated performance ratings for each batch.
• Comparison of batches to peer groups.
• A powerful tool for sorting and comparing batch history data.

3. A customisable web-based user interface providing:

• Batch, master recipe and equipment data accessible from one place
• Ad-hoc web access to data without custom display generation.

viveka.r@expressindia.com

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Quntrol provides complete transparency and ensure integrity through their advanced proprietary digital software platform. Riddhi Javeri, Director, Quntrol Laboratories, gives an insight

According to the World Health Organization (WHO), one in ten medicines in developing countries is fake or substandard. Malaria drugs and antibiotics are among the most commonly reported. However, substandard drugs for cancer, heart disease and HIV, as well as contraceptives and painkillers are also on a rise. Poor quality drugs could endanger health, prolong illness and can also add to the danger of antibiotic resistance. For its part, the London School of Hygiene and Tropical Medicine has estimated that 116,000 additional deaths from malaria could be caused each year by poor quality antimalarials in Sub-Saharan Africa. The WHO estimated that up to 72,000 deaths from childhood pneumonia could be attributed to the use of substandard or fake antibiotics. A report published by WHO on November 28, 2017 highlighted that of the 1500 reports of fake and low-quality medicines, 42 per cent were from Sub-Saharan Africa, 21 per cent from Europe and 21 per cent from the region of the Americas.

The Ministry of Health, Government of Mozambique has taken a leap towards curbing substandard goods from being imported into Mozambique. To this effect, they have implemented a programme of pre-shipment inspection and testing of all pharmaceuticals goods imported into Mozambique. They have started this programme with imports from India since India is their largest supplier of medicines. Approximately, 60-70 per cent of its pharma imports are from India. In value terms, Mozambique imports approximately $88 million worth of medicines from India according to EXIM Database. The Ministry of Health, Government of Mozambique has exclusively appointed Quntrol Laboratories in India to implement the process of pre-shipment inspection and testing for pharma consignments exported from India to Mozambique.

Quntrol Laboratories Private is an independent third-party company offering services of inspection, testing, verification and certification of pharma products. In June 2017, the Ministry of Health signed the MoU with Quntrol to solely appoint us to carry out this process for all pharmaceutical consignments shipped from India to Mozambique. Quntrol’s core expertise is in pharmaceuticals wherein they carry out document verification, inspection and sampling of pharma  consignments, conduct analytical testing of the samples and provide a Clean Report of Inspection and Analysis (CRIA) for the goods exported from India. Quntrol follows best-in-class practices to provide the services. Most importantly, they provide complete transparency and ensure integrity of the process through their advanced proprietary digital software platform. Quntrol’s CRIA is a mandatory document required by Mozambique customs to authorize import of the consignment into Mozambique. he process has had a big impact across every stakeholder, namely the manufacturers, importers, the government and lastly the patients who consume the medication. The exporter is benefited by getting added assurance of the quality of their goods through a third party validation and can save resources by avoiding potential recalls. The importers are assured of the quality of the medicines they are importing and satisfied by knowing beforehand that they are importing what they have ordered. The government is assured of importation of quality medicines and with this policy it can safeguard the health of its citizens. Finally, the consumers have more trust in the medicines they are consuming and is assured of desired outcomes due to independent proof of quality and safety of medicines.

One of the key challenges with respect to pharma quality assurance is known to be integrity of data. Quntrol has developed a software called Quntrol Advantage which is a digital platform that ensures complete transparency and integrity of the process of pre-shipment inspection and testing. Exporters create an account on the portal after they complete registration. Thereafter, they can raise inspection requests and all export related and product quality related documents are uploaded by them on the portal. Quntrol verifies the documents on the portal and schedules the inspection. All relevant documents pertaining to the inspection and testing of the samples drawn during inspection and tested in the laboratory are made available to the Ministry of Health in a special section of the portal, allowing them to be viewed in real time.

Apart from the digital software run process, Quntrol has also ensured various checks and balances to ensure complete integrity of the process. This includes anonymity of the laboratories where analysis takes place, sampling plan generated automatically on the software through an algorithm, sampling plan kept confidential until the time of inspection and security features in the CRIA to avoid duplication.

The analytical laboratories are state-of-the-art, highly accredited and fully equipped to conduct complete analysis of tablets, capsules, oral liquids, topicals, inhalers and all other dosage forms. 21-CFR compliance is followed to ensure data integrity.

With this process being implemented for Mozambique since April 1, 2018, there has been considerable positive impact that has been created. Mozambique has traceability to where the goods were manufactured and whether those sites have adequate licenses and GMP certificates to carry out manufacturing. They can now view data regarding the importers in their country, which products are most commonly being imported, and when the majority of imports take place. Several products have been rejected on the grounds of low content in assay and above limit impurities in related substances. Hence, importation of substandard goods has been avoided. Third party validation of quality has increased seller, buyer and consumer confidence. Manufacturers in India have begun to pay much closer attention to their documentation and quality of products as well. This can only help the manufacturers in the long run, as with better quality control measures being implemented internally, their opportunities for expansion into more tightly regulated markets greatly increases.

For a long time now, India has been known as the pharmacy capital of the world. What is also spoken about by importing countries is the lack of quality control implemented by Indian manufacturers. It is the aim of Quntrol Laboratories that India will be referred to as a nation exporting pharmaceutical goods of the highest quality, and make Indian pharma products the envy of nations worldwide.

The post Pre-shipment inspection, testing and certification of pharmaceutical goods appeared first on Express Pharma.

Virendra Chaudhary, Director, Algor Logistics in a tête-à-tête with Express Pharma, speaks on the crucial role played by temperature-controlled logistics services in India’s challenging domestic pharmaceutical market

Give us an overview of  the services offered by your company.

Algor Logistics is a specialist in the temperature- controlled logistics services space. We transport a range of pharmaceutical goods including active pharma ingredients (APIs), intermediates, formulations, cosmeceuticals, vaccines, and drugs under clinical trial. In addition, our refrigerated trucks ship highly sensitive cargo such as bioplasma, stem cells, and live animals for lab testing, to name a few.

How big is your company in terms of number of employees and market presence?

We have about 50 people on our direct payroll at all-India level as of now. However, we are in the process of hiring new people. So, our headcount is expected to grow by another 10 per cent within a fortnight from now.

We are just a three-year-old company. In 2015 we have already established a pan-India business footprint. Algor has a fleet of over 100 reefer trucks running on Indian roads, delivering high-value materials at client destinations. Of these, nearly 60 vehicles are dedicated to pharma vertical.

What are the challenges faced by pharma companies in India?

It may not be inappropriate or an exaggerated claim to describe India’s pharma sector as vibrant. Besides being the second largest contributor to the world’s biotech and pharma workforce, the industry is also one of the fastest growing sectors in the world. Within two years from now, this globally competitive sector is expected to touch $55 billion in terms of value.

Besides the quality norms under CGMP regulations, pharma companies have to comply with stringent Good Distribution Practices (GDP) laid down by World Health Organisation (WHO). GDP norms mandate that pharma goods be transported in such a manner that their safety, identity, strength, quality and purity characteristics of are well maintained during transportation.
Being highly sensitive, pharma materials (such as APIs, intermediates, formulations, cosmeceuticals, and vaccines) require special handling and care during transport.

The pharma substances being shipped must remain stable during transport. Sensitive materials such as drugs, blood, and blood components must be stored safely at the right temperature. APIs, vaccines, formulations and biologicals should not be tilted and be handled with utmost care. These materials also need to be protected from microbes and pests throughout the duration of their transport.

How does Algor help pharma companies overcome these challenges?

Algor helps pharma companies in India meet their GDP compliance objectives comprehensively. Our fleet of trucks (and vans) are specially designed to ship the pharma cargo. The active and heavy-duty precision cooling inside our reefer vehicles provides a safe, speedy and direct connectivity between the origin and destination.

What are the new developments in Algor? Are there any expansion plans?

As mentioned earlier, we are in the process of inducting fresh talent. The bigger staff strength is essential if we have to undertake business expansion. This expansion is happening on multiple fronts. We are hiring people not just in Mumbai but at various locations in the country to give us a wider market access.

Secondly, we are exploring a few new routes to be added to our network. Already, Algor covers all pharma zones in India as well as the major good transport routes connecting key metropolitan centres such as Mumbai, Ahmedabad, Pune, Delhi, Bengaluru, Hyderabad, Kolkata and Chennai. Given India’s expansive pharma sector, we are looking at adding a few tier-II destinations and giving next day delivery to the cities within 700 km to 1,000 km range.

Are there any major projects on the cards?

One key project this year is the introduction of ALEX, India’s only temperature-controlled, scheduled and express shipment services. This is a unique service and will be in high demand very soon.
Let me briefly explain what is unique about ALEX. There are two types of shipment options available for pharma companies today.

Your consignments can either be full truckload (FTL) or less than truckload (LTL); either scheduled express or consolidated. So when a company wants to ship only a few kilograms of material, it has to either spend as per FTL rates for express delivery or wait for indefinite time for it to get delivered.

ALEX combines all the three ingredients of a great service: Fast (Delivery), Good (Quality) and Cost Efficient. With ALEX, pharma companies can send small consignments with scheduled express delivery timelines without having to spend at FTL rates.

With specially designed reefer trucks, ALEX offers two temperature ranges—20C to 80C and 150C to 250C—to pharma clients. So companies can concurrently ship their goods with differentiated cooling requirements, thus, saving time and costs.

This may be a great news for SMEs as well as enterprises. Your comment.

Certainly! In addition to the big pharma, ALEX can be a great temperature-controlled transportation option for micro, small and medium enterprises (MSMEs). ALEX respects everyone’s budget concerns and offers a solution that offers a truely competitive advantage. Our message to all MSMEs as well as large pharma companies is: Your wait for the right transport option is over. ALEX provides guaranteed express delivery of pharma goods cost-effectively.

Moreover, being GDP compliant and SOP-driven, ALEX scores 100 per cent on all the quality parameters. Ensuring zero-damage to sensitive cargo is our motto. Our field-staff is well-trained to handle pharma materials during transport. Customers can demand real-time temperature monitoring of goods up to the package level. Our backend support team keeps a constant vigil on your consignments with satellite-based monitoring technology. Starting with Mumbai, Hyderabad and Visakhapatnam, ALEX is going to storm all the busy pharma routes in the country very soon.

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