Knowledge Category: Air

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Annex 1 2022 Frequently Asked Questions

Particle Measuring Systems (PMS) recently hosted a webinar about the new Annex 1 2022 Revision. This easy to read compendium for quick consultation consists of questions received in conjunction with the webinar along with questions from years of supporting our customers in their compliance journey. Questions are answered below by industry expert Mark Hallworth.

PaperContinuous Monitoring Concept

Contamination Control Strategies for Innovation and Regulatory Compliance

This paper addresses The 3 Steps of Developing a CCS: Assessment, Acceptance, and Remediation.
1. Assessment: Outline the CCS
2. Acceptance: Compilation of CCS Documentation
3. Remediation: CCS Evaluation

PaperATMP Environmental Monitoring

ATMP Environmental Monitoring

The primary importance of environmental monitoring for Advanced Therapeutic Medicinal Products (ATMP) facilities is to demonstrate the highest degree of control over
* The aseptic manufacturing environment
* The potential for cross contamination between batches / manipulations

PaperUSP 797 Revision

Review of Annex 1: 2022

Read this paper for an easy-to-understand explanation of the meaning of the newest EU GMP Annex 1 2022.Ā The charts provide a section-by-section practical explanation and interpretation of Annex 1.

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