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News about GMP/cGMP

2010-01-28

PIC/S: Re-Interpretation of Annex 1

PIC/S has published a revised version of the recently adopted Recommendation for the technical interpretation of Annex 1 to the PIC/S GMP Guide, which has been prepared by Switzerland / Swissmedic. The Recommendation entered into force on 1 January 2010.

 

The revised Recommendation is the outcome of recent consultations of EEA and PIC/S Competent Authorities in order to reach a common document between the EEA and PIC/S. It summarises the interpretations which an inspector from a national regulatory authority should adopt when performing an inspection of a manufacturer of sterile medicinal products.

It reflects the most important changes introduced in the revised Annex 1 and addresses the feedback received from industry concerning the revision. The interpretation is not meant to address all changes in the revision.

To download the Recommendation click on the link below.

Outcome:

If you are a manufaturer of sterile products, check the PIC/S-Document to finde out if your current SOPs and other quality documents cover the new and changed topics:

  • Operation status of machines (activity/ rest)
  • Clean room / clean air device classification
  • Probe-locations
  • Portable particle counters
  • Clean room re-qualification
  • formal risk assessment on clean rooms/ clean air devices
  • Continuous monitoring in critical areas
  • Continuous monitoring in the B zone
  • Qualification of particle sampler and sampling system in remote systems
  • Sampling during monitoring
  • Monitoring of Grade C and D areas/ number of sampling points and the sampling frequency
  • Media simulations
  • Bioburden
  • Handling of aseptically filled vials after leaving the aseptic processing area up until final sealing
Link:

PIC/S Recommendation for the interpretation of Annex 1

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