Schedule M Browser
Browse the full text of the Revised Schedule M (2025). We've organized the gazette notification into an indexed, searchable structure complete with plain English explanations for complex requirements.
Part IV
Sanitation and Hygiene
Personnel Hygiene
All personnel prior to and during employment shall undergo health examinations. Every person engaged in the manufacture of drugs shall be trained in practices which ensure personal hygiene. Any person shown to have apparent illness or open lesions that may adversely affect the quality of products shall not be allowed to handle raw materials, packaging materials, in-process materials, or drug products until the condition is remediated.
AI Explanation
Staff must get health check-ups before joining and regularly after. Everyone must be trained in hygiene. Anyone sick or with open wounds cannot work with medicines until they've recovered.
Cleaning and Sanitation Programs
Written procedures shall be established and followed for cleaning of premises and equipment. The cleaning procedures shall contain specific details including schedule, methods, equipment to be used and cleaning agents. There shall be validated cleaning procedures to ensure effective removal of product residues, cleaning agents and microbial contamination. Cleaning validation shall include establishment of limits for product residues, cleaning agents and microbial contamination.
AI Explanation
You need written step-by-step cleaning procedures with specific details (what to clean, how often, what products to use). You must prove the cleaning works through validation — show that residues are removed.
Gowning Procedures
Written procedures for gowning shall be established for each production area based on the cleanliness classification. Personnel entering Grade A and B areas shall wear sterilized protective clothing including head covering, face masks, gloves and footwear. The gowning procedure shall be validated to demonstrate that the garments do not introduce unacceptable levels of particulate or microbial contamination.
AI Explanation
Each area needs specific dress code rules in writing. In cleanest areas (Grade A/B), staff must wear fully sterilized gowns, masks, gloves, and shoe covers. You must prove the gowning process itself doesn't add contamination.