FOPE and PharmaState Academy host session 13 of the PULSE series

On January 5, 2025, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 13 of the PULSE (Pharma Upgradation and Learning Series for Excellence) initiative, focusing on materials, reference standards and vendor qualification. The session attracted over 270 attendees, reinforcing the PULSE series’ role as a key learning platform for industry professionals.

Session highlights:

The event began with a keynote address by K Raja Bhanu, Director General, Pharmexcil.  Raja Bhanu commenced the session with a keynote address underscoring India’s burgeoning prominence as a global pharmaceutical leader. He emphasised that India currently holds the third position globally in pharmaceutical production volume and the fourteenth in value, achieving a remarkable $27 billion in pharmaceutical exports in 2024, signifying immense growth potential. Bhanu stressed the critical importance of robust compliance and competitiveness, highlighting that lapses in vendor qualification and material testing can have severe repercussions. He outlined crucial strategies for achieving these goals, including the implementation of risk-based vendor assessment frameworks, ensuring supply chain resilience and financial stability in vendor collaborations, and aligning vendor qualification processes with international standards to bolster export capabilities.

Presentation highlights:

The session was led by Dr Hargovind Seth, Head-QC, Windlas Biotech. He presented a comprehensive overview of the Revised Schedule M and its profound implications for materials management, vendor qualification, and reference standards. He emphasised the criticality of adhering to food-grade standards for materials like cleaning agents and lubricants that come into direct contact with products. Proper storage, labelling, and FEFO rotation of incoming materials were highlighted as essential practices. Regarding reference standards, Dr Seth stressed the importance of procuring primary standards from the IPC or equivalent sources and maintaining working standards with validated procedures and stringent storage conditions. Vendor qualification was presented as a strategic risk management activity, necessitating risk assessment tools, periodic on-site audits, and well-documented SOPs for selection, qualification, and disqualification. The presentation underscored the significance of 100 per cent testing and robust laboratory practices, including meticulous adherence to SOPs for reagent handling, sampling, and dispensing in controlled environments like LAF units, to prevent contamination and ensure product quality.

Panel discussion: 

The session’s panel discussion, moderated by Aprajita Takiar, Managing Director, Lark Laboratories and Senior Vice President, FOPE, featured the following industry experts:

Dinesh Mehandale, Assistant Vice President QA, Relicare Tech Services; Balwinder Kaur, Pharmaceutical Quality Consultant, 35+ years in Quality function and Dr Hargovind Seth, Head-QC, Windlas Biotech.

The panel delved into critical challenges and solutions in vendor qualification and materials management. The panel explored strategies for ensuring compliance with cGMP standards, and methods to address high-risk materials through rigorous testing and documentation, and emphasised the importance of proactive risk management and clear procedures to safeguard product quality. The session including a Q&A, highlighted the significance of engaging with vendors for smoother operations, particularly in globalised markets, the need for 100 per cent testing for specific excipients like sorbitol and glycerine to prevent contamination, and the crucial role of proper labelling, composite sampling, and stability testing of materials.

The next session in the PULSE Series, Investigations and CAPA, is scheduled for February 02, 2025. This session promises to dive into essential practices that can transform pharmaceutical manufacturing processes.

As demand for practical compliance knowledge grows, the PULSE initiative continues to serve as an essential resource for industry professionals.

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)