Session 14 of FOPE & PharmaState Academy’s PULSE Program explores investigations & CAPA under Revised Schedule M

On February 2, 2025, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 14 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Investigations and CAPA. The session attracted over 250 attendees, reinforcing the PULSE series’ role as a key learning platform for industry professionals.

Session Highlights:

Chief Guest: The event began with a keynote address by Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA), Former MD, Abbott Healthcare. During his keynote address, Jain underscored that quality in healthcare is not optional—it is a fundamental license to operate. He emphasised that compliance should not be seen as a burden but as a responsibility towards patient safety. He urged organisations to adopt a proactive approach to Corrective and Preventive Actions (CAPA), ensuring that mistakes are not just corrected but prevented in the future. He highlighted the need for a cultural shift, where leaders set the tone for quality by being the first to uphold and enforce compliance.

Expert Educator: The session was led by Balwinder Kaur, a Pharmaceutical Quality Consultant, 35+ years in Quality function.

Presentation Highlights: Balwinder Kaur provided an in-depth analysis of the Revised Schedule M, focusing on its strengthened pharmaceutical quality system requirements. She highlighted the critical role of investigations and CAPA in ensuring compliance and preventing recurring quality issues. Emphasising a proactive rather than reactive approach, she urged organisations to mitigate risks through thorough root cause analysis (RCA) and systematic documentation.

Kaur stressed the importance of a cross-functional team in handling investigations, ensuring that diverse perspectives contribute to identifying the true root cause. She discussed essential RCA tools, including fishbone diagrams, fault tree analysis, and Pareto analysis, to improve investigative accuracy. Furthermore, she emphasised that poorly implemented CAPA leads to repeated failures, making it crucial to clearly define problems and implement measurable solutions.

She concluded by advocating for a strong, quality-driven culture, continuous training, and robust documentation, reinforcing that true compliance is achieved not through audits alone but through a commitment to ongoing improvement and risk mitigation.

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

• Dr Sanjit Singh Lamba, Managing Partner, Trillyum Consulting and a pharmaceutical veteran with over 35 years of experience
• Dr Jitender Khurana, International GMP Consultant: Quality System, Auditing, FDA Remediation and Training
• Balwinder Kaur, Pharmaceutical Quality Consultant, 35+ years in Quality function

Engaging Q&A Session with Panellists: The discussion on Investigation and CAPA featured insights emphasising the importance of structured investigations and data-driven risk assessments. The panellists highlighted that root cause identification must be thorough and objective, avoiding assumptions and focusing on real-life case studies. Vendor qualification was also discussed, stressing the need for a rigorous process to ensure consistent quality.

Dr Khurana provided key insights into impurity investigations, emphasising the necessity of understanding whether impurities originate from the API or the process itself. Kaur addressed CAPA timelines, underscoring the need for realistic closure periods and traceability within the supply chain. Dr Lamba emphasised the importance of effectiveness checks post-CAPA implementation to ensure long-term resolution. The discussion concluded with a reference to HVAC system management, reinforcing that turning off systems during non-production hours can compromise product quality and compliance.

Looking Ahead: The next session in the PULSE series, focusing on Change Controls and Deviations, is scheduled for February 16, 2025. 

Supporting Associations: The PULSE series continues to receive support from key industry associations including Confederation of Indian Pharmaceutical Industry (CiPi), Laghu Udyog Bharati (LUB), Indian Pharma Machinery Manufacturers’ Association (IPMMA), Karnataka Drugs & Pharmaceuticals Manufacturers’ Association (KDPMA), Himachal Drug Manufacturers Association (HDMA), Federation of Madhya Pradesh Chamber of Commerce & Industry (FMPCCI), Drug Marketing & Manufacturing Association (DMMA), Rajasthan Pharmaceutical Manufacturers Association (RPMA), Pharmaceutical Manufacturers’ Association of Tamil Nadu, Drug Manufacturers Association (DMA)

Stay tuned for updates on the PULSE initiative and upcoming sessions. For inquiries or to pre-book participation, visit PharmaState Academy’s official website.