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segunda-feira, 4 de fevereiro de 2013

WHO: Proposed Text for GMP Annex 3

WHO: Proposed Text for GMP Annex 3:

WHO: Proposed Text for GMP Annex 3

The WHO has published a proposed updated text for “WHO GMP for pharmaceutical products: main principles”, in January 2013. The main principles are published as Annex 3 in the WHO Technical Report Series, No. 961.
 
The paragraphs that are planned to be updated are in
  • Section 1 (pharmaceutical quality system)
  • Section 2 (GMP for pharmaceutical products)
  • Section 7 (contract production and analysis) and
  • Section 17 (good practices in quality control).
Outcome:
Comments on the proposal will be accepted until 29 March 2013, a working document is available electronically. A presentation of the document is planned on the 48th Meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2013.
Source:

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