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18 February 2008

EMEA:
GMP Annex 1 of the GMP Guide has been revised

The revision of the Annex was necessary in particular to align the classification table for environmental cleanliness of clean rooms with ISO standards. Two public consultations took place in preparation of this new revision. The revised Annex 1 provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products. The guidance has been updated in four main areas:

  • Classification table for environmental cleanliness of clean rooms, and associated text
  • Guidance on media simulations
  • Guidance on bioburden monitoring
  • Guidance on capping of vials
The new annex should be implemented by 01 March 2009 except for the provisions on capping of vials, which should be implemented by 01 March 2010.