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Conference ‘Understanding Regulatory Perspectives of Excipients’ hosted by IPEC

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Experts, manufacturers and consumers attending the conference discussed the ever-evolving regulatory framework that guides the Indian excipients industry how active communication between the suppliers and users can decrease instances of quality negligence

The International Pharmaceutical Excipients Council (IPEC) recently organised a conference to boost communication and understanding between manufacturers and consumers involved in the supply chain for the excipients segment. Held in Mumbai, the theme of the one-day conference was ‘Understanding Regulatory Perspectives of Excipients’. Speakers and experts attending the conference also discussed the ever-evolving regulatory framework that guides the Indian excipients industry and the need for Indian manufacturers to diligently adopt global GMP standards in times when they are facing stiff competition from China, USA and Europe.

Commenting on this the issue, Subodh Priolkar, Vice Chairman, IPEC India and CEO, Wincoat Colours and Coatings, spoke during his welcome address, “The Chinese Pharmacopoeia has included functional related characteristics (FRC) in a monograph which will create imbalance under the current regulatory regime. But this would definitely help excipients to perform critical functional attributes for drug safety. These are particle size, mean particle size, bulk density, viscosity, etc besides assay and chemical test. The challenge that lies in this context is that regulated markets cannot modify GMP Requirements for Certificates of Analysis (CoA) and according to Chinese regulations basis if there is a special material manufactured in China as per the local regulations. Just as if any regulated market comes out with a regulation on elemental impurities to comply with, it would be really difficult to comply when we are talking about global regulatory harmonisation.”

“Everyone is realizing that excipients aren’t just inactive ingredients anymore,“ said Rajesh Parab, MD- South Asia, Colorcon and Member Managing Committee IPEC India, as he talked about the emerging role of excipients in the pharmaceutical industry. Speaking about IPEC’s dedication to promote quality, safety and functionality of pharmaceutical and related healthcare products worldwide, Parab introduced the audience with IPEC’s goal to ensure that excipients that are produced, distributed and manufactured are safe and effective. He stated that the excipients industry is significantly different from the pharma industry, and not just its mere sub-segment, he called for the need for this industry to have a proper framework related to supply chain controls and traceability and product consistency.

The next speaker, Vishakha Metkar, Manager-Regulatory Affairs, Colorcon Asia and Managing Committee Member & Chairperson of Regulatory Affairs Committee, IPEC India, spoke on ‘Excipient Qualification And Implementation Of Appropriate Standards’. Citing various worldwide reports of incidents where medications caused grievous health complications due to a certain malignant ingredient, Metkar stated that it is extremely important that manufacturers be diligent about the quality of excipients that are supplied. Poor quality excipients can lead to failure at two stages: during manufacturing causes failure of drug batch production, and when during drug consumption, which could result in serious complications. “It is important that all users improve communication with their suppliers to gain an appropriate understanding of all potential risks and select excipients for formulations and utilize suppliers which will help mitigate risks wherever possible,” she insisted.

Speaking on ‘Qualification Of Alternate Vendor For Excipients’, Mohan Kumar, Head – External Manufacturing MSAT and AVD, Dr Reddy’s Laboratories, talked about Alternate Development Methodology. A proper supplier assessment, he said, should circumvent these components—management, reputation and position in the industry GMP facilities, operation controls, material quality, procedural compliance, delivery mechanism, packaging and transportation, geographical locations, performance history and agreements (quality and legal). On the other hand, quality assessment should incorporate the following factors: Site Master File /Quality Manual, SOP and, Change control systems , Vendor qualification for input materials, Documents filed/control and retained, Batch/lot numbering procedure, Equipment/Instrument qualifications procedures, Quality Control– Input RM, In Process controls Finished product, Microbiological monitoring & control, Input material traceable for batch, Out of Specification, Annual product reviews/Trend, Complaints and Recall procedure.

The following speaker, Dr Ravleen Khurana – Managing Director M/s Nitika Pharmaceutical Specialties, spoke on the topic ‘An Integral Role Of Qbd Excipients In Robust Formulation’. He discussed what factors encompass robust formulation, what does a formulation contain, the role of excipients and QbD with respect to excipients. He also talked about the various disadvantages of having conventional manufacturing practices and what advantage does a QbD approach have.

The last speaker at the conference, Prakash Gadhave, Site Manager – Colorcon Asia and Member, Regulatory Affairs Committee IPEC India, spoke on the challenges that manufacturers face when it comes to Good Distribution Practices. He discussed various factors that cause complications during the supply chain and disasters that can be caused if excipient quality is compromised. He also talked about different professionals who are part of a supply chain system and different pros and cons that suppliers and distributors should abide by.

The conference ended with a question and answer session between the audience members and a panel comprised of OS Sadhwani, Former Joint Commissioner – FDA Maharashtra; Prakash Gadhave, Ravleen Singh and Vishakha Metkar who acted as the moderator. Sadhwani spoke on how the performance of the formulation depends on the excipient, and hence, how it is relevant that drug development is evolved to an extent that it can be made sure that there are no related unintentional impurities in the drug.

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