EU GMP Annex 1, Section 4 - Premises

What it says

Premises used for the manufacture of sterile products must be designed to avoid unnecessary entry of supervisory or control personnel, support the intended airflow and cleanliness classifications, and be part of a facility design that is assessed and justified through the manufacturer's overall Contamination Control Strategy.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Premises design decisions under this section are expected to be traceable back to the facility's Contamination Control Strategy, connecting the physical layout directly to the documented risk-based reasoning required across all of Annex 1.
• Room adjacency and personnel and material flow are central design considerations, since poorly planned flows can undermine cleanroom classification even when individual rooms are built to the correct specification.
• Because premises are expensive and difficult to change after construction, facility design decisions made under this section tend to have long-lasting consequences for a site's contamination control posture.

What inspectors look for

• Whether the facility's premises design is explicitly justified within the site's Contamination Control Strategy, rather than treated as a fixed, unquestioned given.
• Whether personnel and material flow patterns through the premises actually match what the facility's qualification and monitoring data assume.
• Whether premises modifications made since original qualification were assessed for their impact on airflow, classification and contamination control.

Related regulations