COS-GMP Section 11 Explained: Storage and Despatch

By Robert Low, Lead Management System Specialist

Section 11 of COS-GMP covers storage and despatch — the equivalent ground to ISO 22716’s finished products section, restructured slightly and with a few specific additions, including an explicit naming of FEFO stock rotation that ISO 22716 implies but does not name directly.

This post is part of a series working through COS-GMP section by section. The series summary with links to every section is available at the end.

What the Standard Covers

Stock item storage. All stock items — bulk and finished products alike — need storing under conditions appropriate to their nature. Maximum storage duration needs defining and documenting where appropriate, with stored products monitored to ensure conditions remain suitable throughout. Handling needs to account for specific characteristics, associated risks such as allergens or COSHH requirements, and any declared claims such as organic or vegan status. Storage containers need closing or sealing, and purchased materials in easily damaged packaging such as cardboard need storing off the floor.

Identification of stock item containers needs to show name or code, traceability code, storage conditions where critical, quantity and unit of measure where required, and relevant dates. Where a digital inventory system produces barcode labels, these need linking back to the system’s intake records showing this information.

FEFO stock rotation. Except in special circumstances, stock rotation needs to ensure the earliest-expiring material is used first — explicitly named as First-Expiry-First-Out (FEFO), a more precise standard than simply rotating by receipt date, since a later-received item can sometimes expire sooner than an earlier-received one.

Re-evaluations and shelf life. A documented procedure needs to govern shelf life and expiration management and the re-evaluation process, with a system in place to prevent the use of materials that have actually expired — not just materials approaching expiry.

Positive release. All finished products need controlling and verifying against established test methods before market release, meeting defined criteria for quality, safety, and regulatory compliance. Release of both work-in-progress and finished products needs performing exclusively by authorised Technical Compliance personnel or their designated deputies.

Despatch and returns. Shipment measures need to include documentation availability and vehicle inspection prior to loading. Returns need identifying appropriately and storing in defined areas, evaluated against established criteria on arrival, with release given only after re-evaluation — explicitly designed to avoid the inadvertent redistribution of unreleased finished product.

Where This Commonly Goes Wrong

The most common gap is FEFO versus simple first-in-first-out rotation. Many warehouse systems default to rotating stock by receipt date alone, which usually approximates FEFO but is not the same thing — a batch received later with a shorter remaining shelf life needs to be picked before an earlier-received batch with a longer shelf life, and systems that cannot make that distinction will eventually let stock expire on the shelf.

The second common gap is returns handling — specifically, returned product being stored generally rather than in a clearly defined separate area pending the required re-evaluation, creating exactly the redistribution risk this section is designed to prevent.

How This Connects to the Rest of the System

FEFO rotation and expiry tracking depend on stock and inventory management that tracks expiry dates as a first-class field, not just receipt dates. Positive release authority connects to the broader organisational structure and Technical Compliance authority covered earlier in this series.

This post is part of the Cornerstone COS-GMP series. See the full series summary with links to all 11 sections.