Pharmaceutical Contamination Control Frequently Asked Questions

Pharmaceutical Contamination Control Frequently Asked Questions


This FAQ paper is a follow up to the webinar, Pharmaceutical Contamination Control Live Q&A Event presented by Maurizio Della Pietra, Daniele Pandolfi, Giulia Artalli, and Bjarke Madsen. Many thoughtful questions were asked about current standards in the pharmaceutical manufacturing industry. Questions submitted during and after the webinar are answered by our experts, below. If you have any additional queries, submit them directly here.

Some questions covered in this paper are

  • Is there a specific requirement in the EU GMP guidance for updating an FMS system?
  • Is a central vacuum system necessary to implement stationary particle counters/active air sampling for continuous monitoring? What are the pros and cons?
  • How do we satisfy requirements of Annex 1, 9.29 for qualification of recovery efficiency for in-use methods? What elements should be considered for settle plates?
  • Can the Lasair III be used for filter integrity tests?​ What needs to be considered?
  • Many more…..

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