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GMP Guidelines for Pharma MSMEs: Ensuring Quality and Compli



  Aug 23, 2023

Good Manufacturing Practices (GMP) for MSMEs in Pharma


What is 'Schedule M'?

Schedule M refers to the mandatory guidelines established by the Indian government that specify Good Manufacturing Practices (GMP) for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing.
 

Why has the Indian government decided to enforce 'Schedule M'?

The Indian government aims to ensure quality assurance, reduce the compliance burden in the pharmaceutical sector, and bolster the confidence of consumers in the products manufactured by MSMEs. Furthermore, it seeks to reinforce India's reputation as the pharmacy of the world.
 

What are some of the practices outlined in Schedule M?

Schedule M outlines practices related to shop floors, quality control systems, quality control labs, production, and equipment cleaning.
 

What action is being taken against manufacturers who do not comply with these quality standards?

The government has established a special squad to inspect drug manufacturing companies. Stringent actions are in place against manufacturers who make spurious medicines or fail to adhere to quality compliance standards.


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