FOPE & PharmaState Academy conducts session 17 on gap analysis and implementation plan for Revised Schedule M
A structured and well-documented Gap Analysis is essential for identifying deficiencies, strengthening compliance, and ensuring smooth regulatory approvals
The Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy successfully conducted Session 17 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, delivering comprehensive guidance on gap analysis and implementation plan for revised Schedule M compliance. The 3.5-hour workshop provided participants with direction, supplementary documentation, and hands-on learning, ensuring they were well-equipped to meet compliance requirements. Close to 200 participants attended the online workshop.
Session Highlights:
The session began with a keynote address by Dr Chandrashekar Ranga, Joint Drugs Controller (I), CDSCO, who provided valuable regulatory insights. He emphasised that conducting a structured and well-documented Gap Analysis is essential for identifying deficiencies, strengthening compliance, and ensuring smooth regulatory approvals. In addition to his address, Dr Ranga actively engaged with participants, answering their industry-specific queries with clarity and precision. He provided detailed responses on compliance challenges & documentation requirements.
Compliance guidance
The educator for the session, Dr Sanjit Singh Lamba, a global expert with over 35 years of experience in pharmaceutical manufacturing and regulatory compliance and Managing Partner at Trillyum Consulting led a live demonstration covering:
- How to correctly fill Form A as required by regulatory bodies
- How to conduct a structured Gap Analysis to identify compliance gaps
- How to develop a practical and effective Implementation Plan for Revised Schedule M
Dr Sanjit Lamba provided detailed insights, industry best practices, and real-world examples, enabling participants to understand, document, and execute their compliance strategies with confidence.
Addressing industry-specific challenges
The session also featured an extended Q&A segment, moderated by Harish Jain, President of FOPE and Director, Embiotic Laboratories. Participants’ queries were addressed in detail by Dr Chandrashekar Ranga and Dr Sanjit Lamba, who provided practical solutions and expert recommendations tailored to the specific challenges faced by pharma manufacturers.
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)