Good manufacturing practice (GMP)

NEW PUBLICATIONS

• AS OF 23 MAY: Update of WHO biosafety risk assessment and guidelines for the production and quality control of human influenza vaccines against avian influenza A(H7N9) virus
  pdf, 609kb
• WHO Manual for Quality Control of Diphtheria, Tetanus and Pertussis Vaccines

Recommendations/Guidelines adopted by the 63rd WHO Expert Committee on Biological Standardization (ECBS), 15-19 October 2012.

• Recommendations to assure the quality, safety and efficacy of diphtheria vaccines
  pdf, 695kb
• Recommendations to assure the quality, safety and efficacy of tetanus vaccines
  pdf, 837kb
• Recommendations to assure the quality, safety and efficacy of DT-based combined vaccines
  pdf, 912kb
• Recommendations to assure the quality, safety and efficacy of Japanese encephalitis vaccine (live, attenuated) for human use
  pdf, 1.15Mb
• Recommendations to assure the quality, safety and efficacy of live attenuated poliomyelitis vaccine (oral)
  pdf, 1.41Mb
• Annex 1 (OPV)
  pdf, 422kb
• Annex 2 (OPV)
  pdf, 275kb
• Annex 3 (OPV)
  pdf, 282kb
• Guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum
  pdf, 1.02Mb
• Methodological considerations: Potency tests for recombinant adjuvanted RTS,S vaccine
  pdf, 127kb

RECENT PUBLICATIONS

• Meeting Report: WHO Informal Consultation (3-4 April 2012) to develop further guidance on vaccines for UNEP-convened Intergovernmental Negotiating Committee Meeting 4 (INC 4)
  pdf, 501kb

WHO Informal Consultation on the Scientific and Regulatory Considerations on the Stability Evaluation of Vaccines under a Controlled Temperature Chain, Langen, Germany, 4-6 June 2013

Expert Committee on Biological Standardization, Geneva, Switzerland, 21-25 October 2013

CONTACTS

Quality, Safety and Standards (QSS)
Immunization, Vaccines and Biologicals (IVB)
World Health Organization (WHO)
Avenue Appia 20
1211 Geneva 27, Switzerland
Fax No. +41 22 7914971