GxP Disciplines

GSP

Good Storage Practice

What a definition is not

A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.

The discipline governing the proper receipt, storage, and stock-rotation of pharmaceutical products and materials — covering warehouse conditions, temperature and humidity control and monitoring, segregation of quarantined/rejected/recalled stock, pest control, and security — to preserve product quality between manufacture and use, including for retained and reference samples.

GSP addresses everything that happens to a product or material while it sits in a warehouse or distribution center: mapped and monitored storage conditions, first-expiry-first-out stock rotation, physical segregation of quarantined, rejected, returned, and recalled stock from released saleable stock, and controls against pests, cross-contamination, and unauthorized access.

It applies not only to finished products awaiting distribution but also to raw materials, packaging components, and reference/retained samples, each of which may carry different temperature, humidity, or light-protection requirements that the storage facility must be capable of maintaining and demonstrating through mapping and continuous monitoring.

GSP overlaps with, but is distinct from, good distribution practice: GSP focuses on the storage facility and conditions themselves, while distribution practice extends to transportation, temperature-controlled logistics, and chain-of-custody during transit between sites.

KEY POINTS
  • Covers storage conditions, monitoring, and stock rotation, distinct from transport/distribution
  • Requires physical segregation of quarantined, rejected, returned, and recalled stock
  • Applies to raw materials, packaging, finished product, and retained samples alike
  • Storage areas must be mapped and continuously monitored for temperature/humidity
REGULATORY BASIS

WHO Technical Report Series 908, Annex 9 — Guide to Good Storage Practices for Pharmaceuticals (2003)

Frequently asked questions

What does GSP stand for?

GSP stands for Good Storage Practice.

What is GSP?

The discipline governing the proper receipt, storage, and stock-rotation of pharmaceutical products and materials — covering warehouse conditions, temperature and humidity control and monitoring, segregation of quarantined/rejected/recalled stock, pest control, and security — to preserve product quality between manufacture and use, including for retained and reference samples.

Which regulations cover GSP?

WHO Technical Report Series 908, Annex 9 — Guide to Good Storage Practices for Pharmaceuticals (2003)