WHO Good Distribution Practices for Pharmaceutical Products
WHO good distribution practices for pharmaceutical products (Technical Report Series No. 957, Annex 5), the reference GDP standard widely adopted by regulators in emerging markets. Covers the quality system, storage and warehousing, transportation, and the controls needed to preserve product integrity across the supply chain.
Distribution of pharmaceutical products in jurisdictions that reference WHO norms. Frequently the operative GDP baseline where a national GDP guideline is not yet established.
- 01A quality system covering the full distribution operation
- 02Controlled, monitored storage and transportation conditions
- 03Documentation and traceability of received and dispatched products
- 04Handling of complaints, returns, recalls, and counterfeit products
Issued in WHO Technical Report Series No. 957 (2010); later WHO guidance (e.g. TRS 1025 storage and distribution) supplements it.
WHO TRS 957, Annex 5: frequently asked questions
Quick answers to common questions about WHO TRS 957, Annex 5.
What is WHO TRS 957, Annex 5?
WHO TRS 957, Annex 5 — WHO Good Distribution Practices for Pharmaceutical Products — is a guidance issued by the World Health Organization. WHO good distribution practices for pharmaceutical products (Technical Report Series No. 957, Annex 5), the reference GDP standard widely adopted by regulators in emerging markets. Covers the quality system, storage and warehousing, transportation, and the controls needed to preserve product integrity across the supply chain.
Who does WHO TRS 957, Annex 5 apply to?
Distribution of pharmaceutical products in jurisdictions that reference WHO norms. Frequently the operative GDP baseline where a national GDP guideline is not yet established.
What are the key requirements of WHO TRS 957, Annex 5?
WHO TRS 957, Annex 5 requires, among other things: A quality system covering the full distribution operation; Controlled, monitored storage and transportation conditions; Documentation and traceability of received and dispatched products; Handling of complaints, returns, recalls, and counterfeit products.
When was WHO TRS 957, Annex 5 last updated?
The current version of WHO TRS 957, Annex 5 dates from January 2010. Issued in WHO Technical Report Series No. 957 (2010); later WHO guidance (e.g. TRS 1025 storage and distribution) supplements it.
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