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Indian pharmaceutical industry.

Article

Rajani Jha

Senior Pharmaceutical Scientist and Consultant [ RegulatoryAffairs and GMP]

Quality Oversight – Pharmaceutical Quality Systems and Culture – critical for Regulatory & GMP Compliance

Pharmaceutical Quality Management Systems in industries are most of the time lacking serious involvement of the higher management in terms of Effective monitoring and controls. The Quality Oversight concept[expectations/ Requirements]has been defined long back by Regulatory Authorities particularly by the US-FDA and EMA. However there are huge gaps prevailing with respect to this aspect as of now in the Indian Pharmaceutical industry. Quality Oversight by definition is the method/process of Supervision i.e., keeping a Quality Process or system under constant observation fm appropriate checks and alert/alarm systems to ensure proper controls. It relates to the independence of Quality systems and procedures to ensure an unbiased quality assurance of the pharmaceutical products reaching the end user. This has been identified as a critical and ongoing problem by Regulatory Agencies and is pretty much evident from the recent 483s, Warning letters and Import alerts issued by these agencies to Pharmaceutical organizations worldwide. Awareness regarding all relevant guidance implementing the critical aspects relevant to an organization’s product grid via the right written down procedures and managing the transition phase are instrumental in carving out the right pathway to identify & bridge these gaps. Awareness regarding all relevant guidance implementing the critical aspects relevant to an organization’s product grid via the right written down procedures and managing the transition phase are instrumental in carving out the right pathway to identify & bridge these gaps .
The cross functional team members need to be more conversant with the current gaps in their organizations regarding Quality oaersight to bridge them and align themselves with current global Regulatory Expemarions as an ongoing process. By channelizing the Management for effective monitoring to scent systems and process., organizations can eff.tively manage the risks involved via timely decisions in tams of mitigation & nee ,. controls to ensure faster approvals of Marketing Authorization applimtions to meet business aspirations of the Company.
The Challenge lies in Designing & implementing the best suited Quality Oversight Programs which translate into adequate Regulatory/GMP Compliance as evident from increasing no. of 483s and Wanting Letters pertaining to Responsibilities of the Management and Quality Control Units repeatedly. The Key constraints -both intemal[organizational-Multiple Manufachuing sites] & ex.mal [outsourcing of materials/equipment or some specific activities as analyses of packaging materials & stability studies sample]remain a challenge to handle this crucial aspect.

In Conclusion

Industries can effectively deal with these issues by accepting the gaps and bridging them by designing, reviewing, revising, rectifying & restructuring the Quality Management Systems as well as implementing best practice quality improvement programs to ensure all round necessary Compliance. This needs involvement of all stakeholders wrt necessary inputs both during development and commercialization vis-a-vis Global Regulatory requirements & can be facilitated by various vendors whose services are utilized for buying raw materials, apparatus and equipments for Process and Analytical departments & commercial Production units and various Software & hardware providers for Design of Experiments [DoE]studies , eCTD registrations, Genotoxic impurities assessment and many more- by proper mutual agreements.

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