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Revised Schedule M guidelines require applicability of WHO guidelines on water, HVAC systems, etc: Dr Reddy
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Shardul Nautiyal, Mumbai
October 04 , 2023
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The proposed Revised Schedule M guidelines would now require applicability of World Health Organization (WHO) guidelines on quality of water, HVAC systems, validation and packaging of pharmaceutical products, informed Dr. S Eswara Reddy, Joint Drugs Controller of India, while speaking on the sidelines of a recent workshop on “Revision of Schedule-M” in Mumbai as a keynote speaker.
He further highlighted that revised Schedule M guidelines is required because Good Manufacturing Practice (GMP) is a dynamic process and there has been a substantial improvement in the concept of drug quality since the inception of guidelines three decades back.
The workshop was organised by the Central Drugs Standard Control Organisation (CDSCO) in association with the Indian Drug Manufacturers’ Association (IDMA). The objective of the workshop was to make the participants aware of the proposed changes to the Schedule-M and prepare for implementation at the earliest.
Dr. Reddy further emphasized that there is a need to update GMP in order to retain the credibility of India as a Pharmacy to the World. He informed that in 2001, Second Amendment to the GMP was made based on 1992 WHO GMP guidelines. These guidelines were effective from December 11, 2001 for new units and January 1, 2004 for existing units which were further extended for one year.
A draft notification was further issued on October 5, 2018 to upgrade and synchronize the Schedule M of the Drugs and Cosmetics (D and C) Rules, 1945 in compliance with WHO-GMP standards.
Schedule-M prescribes requirements to the manufacturing plants of pharmaceutical companies for maintenance, manufacturing, control and safety testing, storage and transport material, written procedures and records, and traceability among others.
“The WHO GMP guidelines regarding the design, installation and operation of pharmaceutical water systems now also include guidance about which quality of water to be used for specific applications such as the manufacturing of active pharmaceutical ingredients (APIs) and dosage forms. It also stipulates guidelines on design, installation qualification and maintenance of the heating, ventilation, air conditioning (HVAC) systems of the pharma manufacturing plant,” explained Dr Reddy.
Observation from ongoing risk-based inspections necessitated the government to take a re-look at the current GMP regulations and quality management systems (QMS) being followed by the Indian pharmaceutical manufacturers.
GMP comprises mandatory standards that build and bring quality to products by way of control on materials, methods, machines, processes, personnel, and facility or environment, etc. The GMP system was first incorporated in 1988 in Schedule M of the D&C Rules, 1945, and the last amendment was made in June 2005. WHO-GMP standards are now part of the revised Schedule M.
Some of the major changes which will happen with introduction of the revised Schedule M are introduction of pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, change control management, self-inspection, quality audit team, suppliers audit and approval, stability studies as per recommended climate condition, validation of GMP-related computerised system and specific requirements for manufacturing of hazardous products among others.
The CDSCO also recently conducted workshops on Revised Schedule M in Hyderabad and Ahmedabad and is also in the process of conducting it in Chandigarh and other places.
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