The Central Drugs Standard Control Organization (CDSCO) is teaming up with the Food and Drug Control Administration (FDCA) Gujarat and the Indian Drug Manufacturers Association (IDMA) to host a focused one-day workshop titled “Vendor Audit/Validation as per the Updated Schedule M Guidelines.” Scheduled for November 30, 2024, in Ahmedabad, this workshop promises to offer in-depth knowledge and practical strategies surrounding the recent revisions to Schedule M, with an emphasis on validating and auditing vendors.
Aimed at pharmaceutical professionals, regulatory specialists, and relevant stakeholders, the event will provide a platform for learning about comprehensive compliance practices in line with the new guidelines.
Notable elements of the workshop include expert-led sessions where authoritative figures from the industry and regulatory bodies will present thorough discussions on the Revised Schedule M. These presentations will focus on its impact on vendor evaluation and adherence requirements.
Following the presentations, there will be interactive components such as Q&A sessions and group discussions, designed to allow participants to clear up uncertainties and exchange effective practices.
Attendees will also gain insight into the compliance expectations articulated by CDSCO and FDCA Gujarat, aiding organizations in aligning seamlessly with regulatory directives.
The workshop stands as an essential event for pharmaceutical producers and related professionals wanting to synchronize their processes with the latest compliance frameworks, thereby ensuring superior quality and adherence throughout the supply chain.
The revised Schedule M guidelines allocate responsibilities for pharmaceutical manufacturing units in India, instructing companies on necessary certifications and validations to prove conformity with Good Manufacturing Practices (GMP). This includes ensuring that equipment undergoes both qualification and validation.
Pharmaceutical companies are also required to implement a pharmaceutical quality system (PQS), engage in quality risk management (QRM), conduct product quality reviews (PQR), and utilize computerized storage systems for all drug products.
“This joint effort highlights the commitment of CDSCO, FDCA Gujarat, and IDMA towards advancing compliance and achieving distinction within the pharmaceutical sector,” stated Dr. H G Koshia, Gujarat FDCA Commissioner.