EU GMP ANNEX 1

Cleanroom PPE should be selected based on cleanroom grade, process risk, and the potential for operator-borne contamination. Garments, gloves, facemasks, goggles, footwear, and gowning practices should work together as a coordinated Head-to-Toe contamination control system, not as separate product choices.

Selection should be supported by clear rationale within the Contamination Control Strategy (CCS), with evidence available to demonstrate suitability, sterility, traceability, and intended use.

Learn more about selecting PPE as part of a contamination control strategy in Why Cleanroom PPE Belongs in Your CCS and EU GMP Annex 1: Are You Dressed for the Part?

QA teams should be able to retrieve evidence that supports PPE selection, release, traceability, and suitability for intended use.

Typical PPE-related evidence may include:

• Declarations of Conformity
• Sterilisation method and sterility assurance level information
• Product specifications
• Intended use information
• Material performance or suitability data
• Packaging and expiry information
• Lot-level documentation. 

The key principle is not simply that documentation exists. It should be accessible when needed and aligned with the site’s CCS, QRM approach, and internal quality procedures.

Annex 1 requires contamination control to be considered across the manufacturing process, including people, facilities, equipment, materials and procedures.

Cleanroom PPE and gowning practices should be linked to the CCS because personnel are a significant source of contamination risk. The CCS should provide the rationale for PPE selection, gowning controls, glove practices, sterilisation requirements, and supporting evidence for routine operations. 



Where PPE practices are not clearly defined or justified, variation in behaviour can occur, increasing deviation risk and weakening quality documentation

For a deeper look at how PPE supports a CCS and contamination risk management, read Why Cleanroom PPE Belongs in Your CCS.

PE-related non-conformances often arise when routine practice, rationale, and documentation are not aligned.



• Common areas include:

• inconsistent aseptic donning technique

• glove and garment interface exposure at the wrist or forearm

• unclear rationale for double gloving or glove change frequency

• insufficient eye and face coverage

• PPE substitutions without documented risk assessment

• documentation that is not easily retrievable during deviations, investigations, or inspections



These issues can increase contamination risk and deviation likelihood, especially in Grade A/B operations where gowning discipline and operator behaviour are critical control points. Common PPE-related deviations often originate during gowning and donning activities. Read Aseptic Donning in Cleanrooms: Best Practices and Compliance for practical guidance.

Yes. PPE should be considered a people-related control within the CCS. A Head-to-Toe approach helps ensure that gloves, garments, eye and face protection, footwear and other PPE elements are selected as a coordinated system, reducing variability and supporting contamination-control objectives.

This approach supports risk-based decision making but does not by itself guarantee compliance.

Learn more about cleanroom PPE as part of a contamination control strategy in Why Cleanroom PPE Belongs in Your CCS