Category: Cleaning

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White Paper: Human Contamination and Controlled Access in Clean Room Environments – Compliance with Annex 1, Paragraph 7.2

Jason Carter,  jcarter@nav-team.com,  Nav-Team, Inc.AbstractThe critical issue of human contamination in clean room environments, with a focus on compliance with Annex 1, Paragraph 7.2, of the European Union Guidelines to Good Manufacturing Practice (GMP). Personnel represent a significant contamination risk in sterile manufacturing, introducing both viable and non-viable particles into controlled environments. Annex 1 mandates […]

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Annex 1 & Contamination Control Strategy

Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAIAnnex 1 and a Contamination Control Strategy are critical aspects of pharmaceutical manufacturing, focusing on maintaining quality, safety, and compliance as is expected in a regulatory setting.  Annex 1 of the European Union’s Good Manufacturing Practice (GMP) serves as a guideline and cornerstone for sterile […]

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