COS-GMP Section 7 Explained: Premises and Site Standards

By Robert Low, Lead Management System Specialist

Section 7 of COS-GMP covers premises and site standards. The underlying objectives match ISO 22716’s premises section closely — protecting product, enabling cleaning, and minimising mix-up risk — but COS-GMP is more prescriptive about documentation, specifically requiring a formal site plan that several other clauses then reference 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

General and the documented site plan. Beyond the standard location, design, and construction principles, COS-GMP specifically requires a documented site plan — a single reference document that the control zones and flow requirements both build on directly.

Control zones. GMP control zones and their risk status need clearly defining and documenting on the site plan, with separate or defined areas for storage, production, quality control, ancillary functions, washing, and toilets. Clear signage needs providing so personnel entering control zones understand the restrictions and controls in place — an explicit signage requirement that goes beyond ISO 22716’s equivalent clause.

Flow. The flow of stock items, personnel, and waste needs defining to prevent mix-ups and documenting on the site plan, with the layout from intake to dispatch organised to minimise contamination or damage risk.

Infrastructure. Walls, floors, ceilings, doors, and windows need designing for ease of cleaning and sanitisation. Windows need protecting and regularly checked for breakages with records maintained — a specific, recorded breakage-check requirement. Floors need to be hard-wearing with no damaged, delaminating, or flaky paint. Pipework, drains, and ducts need installing to prevent contamination from drips or leaks, with both internal and external drains kept clear, and pooling water specifically called out as something to avoid with recorded corrective action where it occurs.

Staff facilities. Break rooms, locker rooms, changing rooms, washing rooms, and toilets need to be suitable, clean, and clearly separated from production and storage. Personal belongings need storing away from product and eating areas, without contact with GMP-required PPE. Where cleaning happens within staff facilities, dedicated equipment separate from GMP control zones is required — often implemented through colour-coded cleaning equipment.

Cleaning, maintenance, pest control, and waste. Cleaning and sanitisation programmes need defining specifically for each control zone, staff facility, and office space, covering equipment, materials and dilutions from the Approved Materials Register, and contact times. All cleaning and sanitising activity needs validating for effectiveness at the specified dilutions and times. Maintenance needs a documented preventative programme. Pest control needs a signed, documented agreement acknowledged by both the service provider and the responsible person internally. Waste disposal needs licensed contractors where legally required, with removal records available for audit.

Where This Commonly Goes Wrong

The most common gap is the documented site plan not actually being kept current as the facility changes over time — control zones, flow paths, and signage requirements drift from what is physically true while the plan itself remains unrevised.

The second common gap is cleaning validation — programmes exist and get followed, but the specific validation step confirming the materials are actually effective at the dilutions and contact times specified often gets treated as assumed rather than demonstrated.

How This Connects to the Rest of the System

The site plan and control zone definitions connect closely to the risk control and HARA process covered earlier in this series, since contamination risk assessment depends on an accurate understanding of facility flow and zoning. Pest control and cleaning programme records also benefit from being tracked through document control given the contractual and validation evidence this section requires.

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