Compliance you can rely on

The requirements of EU GMP Annex 1 have a direct impact on systems, processes and behaviour in the cleanroom. As soon as technical interpretations, processes or verifications are not clearly formulated, uncertainty arises in production and preparation for inspections and audits.

The Bausch+Ströbel Annex 1 Services include services that provide targeted support in the assessment and implementation of these requirements. These include services for analysing aseptic processes, assessing air flows and aspects relating to the Contamination Control Strategy. The focus is on presenting risks transparently and integrating measures into existing production environments in a practical manner.

Our Annex 1 services support you in implementing regulatory requirements in a structured manner and providing reliable assurance of assumptions, measures and evidence.