GMP附录1最新草案修订更新

GMP附录1解析：知识点/白皮书

• EU Annex 1:Impact on Environmental Monitoring for Clean Manufacturing

  On December 20th, the first draft for a Revision of EU ANNEX 1 was published for public comment. Particle Measuring Systems put together a team of industry experts to provide their insights of the new aspects of environmental monitoring in sterile manufacturing and its probably implications to Pharmaceutical manufacturers.

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• Annex 1 Revision 2017 Comments from Industry Experts

  The updated EU GMP Annex 1 Draft was released for public comment in December 2017, and the industry experts at Particle Measuring Systems have shared their response on the revision.

   

   

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• Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for Annex 1 FAQ

  Viable monitoring requirements and solutions per the latest Annex 1 draft (rev 12) are discussed here by industry experts. Watch the on-demand webinar and access FAQS here.

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• Concerned about how Annex 1 might affect you?  

  Industry experts answer over 40 common Annex 1 draft questions including:

  • During cleanroom classification, is it mandatory to monitor viable and non-viable counts simultaneously?
  • Can you choose not to use one of the microbiological sampling methods for qualification of a classified area?
  • Does the removal of the 5 micron particle size from ISO 14644 mean the qualification time for Grade A and B will be vastly reduced?
  • Have particle sizes greater than 5.0 been removed as a requirement of Grade A or B monitoring?

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