FOPE and PharmaState Academy hosts Session 11 of the PULSE series

On December 15, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 11 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Good Practices In Quality Control. 

The event began with a keynote address by Dr Y K Gupta, President, AIIMS Jammu, and Principal Adviser, GARDP (Global Antibiotic Research and Development Partnership). Dr Gupta discussed the importance of quality control in the pharmaceutical industry, emphasising that patient safety and reputation are paramount. He highlighted the need for stringent quality measures, particularly considering India’s status as a hub for generic drugs.He concluded by emphasising the need for continual improvement in quality and the importance of building trust and confidence in the industry.

The session was led by Dr Deo Narain Dikshit, Director at AQEX Phamasolutions, former VP and Regional Quality Head, Asia in Sun Pharma.

Dr Dikshit discussed the importance of validation in the quality control process, emphasising the need for user requirement specifications for standard equipment. He presented on good practices in quality control, highlighting the importance of appropriate qualifications and experience, and adequate facilities for storage and sampling. He mentioned the necessity of having license number, and manufacturer address on certificates of analysis. He also discussed the importance of having retention samples for raw materials and packaging materials and the role of quality control in investigating deviations and ensuring the stability of raw materials. He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices. He mentioned the role of quality assurance in ensuring these practices are followed. He also touched upon the importance of maintaining retention samples and adhering to stability guidelines. The importance of data integrity in the pharmaceutical industry, emphasising the need for completeness, consistency, and accuracy of raw data was also discussed. He explained the concept of metadata and the data lifecycle, highlighting the importance of data management, access control, configuration control, and authority control at different levels.

Panel Discussion: The session’s panel discussion, moderated by Harish K Jain, President FOPE, Director Embiotic Laboratories, featured the following industry experts:

• Dr Jitender Khurana, International GMP Consultant, Quality System, Auditing, FDA Remediation and Training.
• Subhrangshu Chaudhury, Vice President & Head of Quality at Centaur Pharmaceuticals
• Dr Deo Narain Dikshit, Director at AQEX Phamasolutions, Former VP and Regional Quality Head Asia in Sun Pharma.

Engaging Q&A Session with Panelists: The interactive Q&A session focused on various aspects of the pharmaceutical industry, including testing methods, vendor management, and regulatory compliance. Jain discussed the potential for a paperless system and the importance of impact analysis for new amendments. Chaudhary explained the necessity of sampling excipients and the exemption for dedicated facilities. Dr Khurana stressed the importance of risk-based testing and the need for proper documentation. The panel also discussed the role of analytical method validation when outsourcing testing and the necessity of Excel sheet validation. 

The panellists patiently addressed participants’ questions on quality control practices in pharmaceutical manufacturing, particularly in the microbiological and chemical analysis sections. They emphasised the importance of maintaining a controlled environment in microbiological labs, comparable to sterile manufacturing facilities while highlighting the need for proper documentation and comprehensive risk assessments. Additionally, they discussed strategies to minimise human error through automation and stressed the significance of ensuring compliance with computerised systems. The panel discussion ended by highlighting the need for a controlled environment, automation, and equal responsibility for product quality.

Looking ahead: The next session in the PULSE series, focusing on Complaints and Product Recall, is scheduled for December 29, 2024. As demand for practical compliance knowledge grows, the PULSE initiative continues to serve as an essential resource for industry professionals.