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
Waste materials
Key considerations for Point No. 16 – Waste materials for compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 15 – Reference Standards
Pharma Manufacturers’ Compliance for Waste Management:
Proper Storage of Waste Materials:
Toxic and flammable substances must be stored in designated, enclosed cupboards.
Regular Waste Removal:
Waste materials should not accumulate and must be collected in suitable receptacles.
Regular and frequent removal to designated collection points outside the building.
Safe and sanitary disposal methods must be followed.
Environmental Compliance:
Disposal of sewage and effluents (solid, liquid, and gas) must adhere to Environmental Pollution Control Board guidelines.
Biomedical Waste Management:
Destruction of biomedical waste as per Bio-Medical Waste (Management and Handling) Rules, 2016.
Contamination Prevention:
Rodenticides, insecticides, fumigating agents, and sanitizing materials should not contaminate equipment, materials, or products.
Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 17 – Documentation
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
Dissolution test: Importance in Pharma Industry
NSQ Drug: Route cause analysis and CAPA
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
