CDSCO: Indian Agency Drafts Revised GDP Guidelines
The Central Drugs Standard Control Organization (CDSCO), the Ministry of Health, and the Government of India have released a 25-page document Draft Guidelines on GDP for Pharmaceutical Products. The guidelines have been developed following WHO TRS 1025 – Annex 7: Good Storage and Distribution Practices for Medical Products, with a broader focus on pharmaceutical product storage.
These guidelines aim to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. Aspects include organization management, personnel, quality systems, premises, temperature, environmental and storage control, transportation, shipment containers and labeling, dispatch and receipt, documentation, complaints, recalls and returns, handling spurious products, importation, contract activities, and self-inspection.
It applies to all entities involved in different stages of the supply chain of medical products, manufacturers and wholesalers, as well as brokers, suppliers, distributors, logistics providers, traders, transport companies and forwarding agents and their employees.
A 30-day comment period on the draft guidance has started on 9 August 2024.
Source:
WHO: TRS 1025 – Annex 7: Good storage and distribution practices for medical products
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