WHO, Production, gmp for pharmaceuticals.#Gmp #for #pharmaceuticals


Posted On Feb 14 2018 by

Production

Gmp for pharmaceuticals

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

WHO good manufacturing practices

  • WHO good manufacturing practices for pharmaceutical products: main principles

Annex 2, WHO Technical Report Series 986, 2014

  • French version

    Annex 2, WHO Technical Report Series 957, 2010

  • French version

    Annex 5, WHO Technical Report Series 885, 1999

  • WHO good manufacturing practices for sterile pharmaceutical products

    Annex 6, WHO Technical Report Series 961, 2011

  • WHO good manufacturing practices for biological products

    Annex 3, WHO Technical Report Series 996, 2016

  • WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization)

    Annex 4, WHO Technical Report Series 961, 2011

  • Pharmaceutical products containing hazardous substances

    Annex 3 WHO Technical Report Series 957, 2010

  • French version

    pdf, 454kb

  • Investigational pharmaceutical products for clinical trials in humans [pdf 4Mb]

    Annex 7, WHO Technical Report Series 863, 1996

  • Herbal medicinal products

    Annex 3, WHO Technical Report Series 937, 2006

  • Radiopharmaceutical products

    Annex 3, WHO Technical Report Series 908, 2003

  • Water for pharmaceutical use (English version)

    Annex 2, WHO Technical Report Series 970, 2012

  • French version

    pdf, 377kb

  • Japanese version pdf, 537.2 kB
  • WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms

    Annex 5, WHO Technical Report Series 961, 2011

  • Validation

    Annex 4, WHO Technical Report Series 937, 2006

  • Guidelines on good manufacturing practices: validation, Appendix 7: non‑sterile process validation 1

    Annex 3, WHO Technical Report Series 992, 2015

  • Risk analysis

    • Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals

    Annex 7, WHO Technical Report Series 908, 2003

    Technology transfer

    • WHO guidelines on transfer of technology in pharmaceutical manufacturing

    Annex 7, WHO Technical Report Series 961, 2011


    Last Updated on: February 14th, 2018 at 1:14 pm, by


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