An NSF International Company Rx-360 Summary of India Draft GDP Guidelines for Biological Products
Monday the 8th October 2012
The Central Drugs Standards Control Organization (CDSCO) of India posted a draft Guidelines on Good Distribution Practices for Biological Products on their web site on September 17, 2012. This is available for comment for 15 days after posting.
The scope of the document is broad and covers storage and distribution activities from the site of manufacture to the point at which product is dispensed or administered to the patient. Its scope also includes manufacturers of bulk (though it isn’t clear whether this means drug substance or bulk drug product) and finished products. The draft Guideline addresses activities required for participants in the distribution supply chain, including but not limited to:
- Organization and Management
- Quality System
- Premises Warehouse and Storage (includes requirements for temperature mapping)
- Temperature, Environment and Storage Control
- Transportation
- Documentation
Similar to the EU draft GDP Guidelines, this also states that product is to be stored and transported at “conditions described on the label”. Specific details are provided in paragraphs 10.1, 11.1 and 11.6. Paragraph 13.1 states “Validated temperature-control systems…shall be used to ensure that correct transport conditions are maintained between the distributor and customer.” If customers request data demonstrating that the product was maintained within the specified temperature range this should be provided (paragraph 13.2). Paragraph 4.3 requires that the “principles of GDP” are met for returned and recalled product.
To view or download the draft guidance document, click here
To view or download the Rx-360 Summary of the draft guidance, click here
