Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on January 4, 2025 by The Health Master
Reference Standards
Key considerations for Point No. 15 – Reference Standards compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 14 – Materials
To ensure compliance with Good Manufacturing Practices (GMP) for pharmaceutical products, manufacturers must adhere to the following principles regarding Reference Standards:
Pharmaceutical manufacturers must:
- Use official reference standards whenever available.
- Procure Indian Pharmacopoeia reference standards from the Indian Pharmacopoeia Commission.
- Use official reference standards only for the purposes outlined in the relevant monograph.
- Test, release, and store manufacturer-prepared reference standards like official standards.
- Designate a responsible person to oversee the storage of manufacturer-prepared reference standards in a secure area.
- Establish secondary or working standards through regular testing and checks to maintain standardization.
Label reference standards with the following information:
- Name of the material
- Batch or lot number and control number
- Date of preparation
- Shelf-life
- Potency
- Storage conditions
- Standardize in-house working or secondary standards against an official reference standard, if available, initially and periodically.
- Store and use all reference standards to prevent quality degradation.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 16 – Waste materials
Key Notes on Revised Schedule M: Compilation
Important short notes for Industry and Regulators
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Quality Assurance Vs Quality Control in the Pharma Industry
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Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
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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
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