EU GMP Annex 1, Section 6 - Equipment

What it says

Equipment used in sterile product manufacture must be designed to minimize contamination risk, be readily cleanable and sterilizable where required, and be qualified and maintained under a program that demonstrates ongoing suitability for its intended use within the site's Contamination Control Strategy.

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

What it means in practice

• Equipment design choices made at procurement, such as how easily a piece of equipment can actually be cleaned and sterilized, have lasting contamination control consequences that are difficult or expensive to correct after installation.
• Ongoing equipment qualification and maintenance is expected to be risk-based and tied into the Contamination Control Strategy, rather than treated as a standalone preventive maintenance schedule disconnected from contamination risk.
• Equipment changes or repairs, even ones that seem purely mechanical, can alter a piece of equipment's contamination control performance and may warrant requalification before it returns to use.

What inspectors look for

• Whether equipment qualification and maintenance records demonstrate ongoing suitability for sterile manufacturing, not just a one-time installation qualification.
• Whether equipment repairs or modifications were assessed for their potential impact on contamination control performance before the equipment returned to use.
• Whether equipment cleaning and sterilization procedures are validated and consistently followed, particularly for equipment that is difficult to access or disassemble.

Related regulations