Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on March 15, 2025 by The Health Master
Sanitation and Hygiene
Key considerations for Point No. 4 – Sanitation and Hygiene compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 3 – Good Manufacturing Practice (GMP)
Sanitation and Hygiene Requirements for Pharmaceutical Manufacturers
High Level of Sanitation and Hygiene:
Maintain strict sanitation and hygiene standards throughout the entire drug manufacturing process.
Comprehensive Coverage:
Ensure sanitation and hygiene practices cover all aspects of the manufacturing process, including:
- Personnel
- Premises
- Equipment and apparatus
- Production materials and containers
- Cleaning and disinfection agents
- Any potential source of contamination
Integrated Sanitation and Hygiene Program:
- Implement a comprehensive program to eliminate potential contamination sources.
- This program should integrate all sanitation and hygiene aspects into a unified approach.
Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 5 – Qualification and validation
Gist of 31 Chapters on Schedule M
Revised Schedule M Guidelines: Drug Recall and Ensuring Pharma Quality
Pharmaceutical Quality: Key Amendments in Revised Schedule M
Revised Schedule M: The Role of Pharmaceutical Waste Management
Gap analysis for Revised Schedule M
Important short notes for Industry and Regulators
Key Notes on Revised Schedule M: Compilation
Important short notes for Industry and Regulators
CDSCO Guidelines on Drug Recall
Quality Assurance Vs Quality Control in the Pharma Industry
Major FDA audit findings about Equipment and Instruments
Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Licensing procedure for manufacturing of Drugs
Procedure to obtain license for manufacturing of Cosmetics
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Procedure to obtain license for manufacturing of Medical Devices
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Blood Centre (Blood Bank)
Procedure to obtain license for Commercial Testing Laboratories
