A REVIEW ARTICLE ON AN EXISTING SCHEDULE M VS REVISED SCHEDULE M

Schedule M is considered as an important part in the Drugs and Cosmetics Act 1940, Rules 1945. For making a product with proper quality and effective for the human beings it is necessary to maintain or follow the guidelines of schedule M. Schedule M is considered as the guidelines which talks mostly about Good Manufacturing Practices. Schedule M was first established in the year 2001 and it was divided into Part 1 and Part 2. Then in the year 2018 it was divided into 12 Parts more precisely than first one which was established in the year 2001. Then in the year of 2024 it became more precise, and it was divided into 13 Parts and including the changes introduced in, the revised Schedule M which include introduction of a Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), Qualification and Validation of Equipment, and a Computerized Storage system for all drug products. These revised Schedule M will help in making the product proper and effective to the human beings. The revised Schedule M makes it easy for the identification of the risk and to check whether the product is maintaining quality system or not. The revised Schedule M will make the records of the documentation for future references. Schedule M is a crucial part for all the manufacturing products used by the human. Previous Schedule M doesn’t give much explanation about each topic which creates problems most of the time. It is better to be revised.