#ScheduleM is a crucial component of the #Drugs and #Cosmetics Rules in India. It outlines the Good Manufacturing Practices (#GMP) and requirements for premises, plant, and equipment for pharmaceutical products.
âž¡ Key Aspects of Schedule M:
#Rules: Schedule M is associated with rules 71, 74, 76, and 78.
#Objectives: The revised Schedule M aims to ensure that each licensee develops appropriate methodologies, systems, and procedures.
#Documentation: These methodologies, systems, and procedures must be documented and maintained for inspection and reference.
#Exclusive Production: The manufacturing premises should be used exclusively for the production of drugs.
âž¡ Recent Improvements:
✅ Centralized Database for Unsafe Drugs:
✔ In a circular dated February 9, the CDSCO instructed drug inspectors across India to follow new guidelines for sample collection.
✔ The goal is to maintain a centralized database of Not of Standard Quality (NSQ)/spurious drugs for public disclosure.
✔ This move enhances transparency and accountability by identifying and tracking unsafe drugs.
✅ Emphasis on Excipients and Formulation Standards:
✔ CDSCO’s new drug sampling guidelines focus on the role of excipients (inactive ingredients) and advanced technology in formulation development.
✔ These changes aim to improve the quality of pharmaceuticals and public health in India.
✔ Despite challenges due to a shortage of drug inspectors, the CDSCO is committed to enhancing drug quality.
✅ Uniform Drug Sampling Methodology:
✔ The CDSCO has issued new guidelines for effective surveillance of drug and cosmetic quality in the market.
✔ These guidelines promote uniformity by adopting consistent drug sampling methods across the country
âž¡ Role of FWQRC-Global GxP & Regulatory Consultant
✅ FWQRC-Global GxP & Regulatory Consultant, a business partner, has initiated the process to identify the gaps in the existing manufacturing facilities. They have also provided support with remedial actions for the identified gaps in several medicinal products manufacturing industries in India.
âž¡ Conclusion:
Understanding and implementing Schedule M is vital for maintaining the quality of pharmaceutical products. It ensures that the manufacturing processes adhere to the highest standards, thereby safeguarding public health. With the support of consultants like FWQRC-Global GxP & Regulatory Consultant, pharmaceutical companies can effectively navigate the complexities of Schedule M and ensure compliance
