WHO Technical Report Series


The WHO Technical Report Series makes available the findings of various international groups of experts on a broad range of medical and public health subjects. It includes the reports of the annual meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP). An Expert Committee is the highest official advisory body to the Director-General of WHO, as well as to all its Member States. An Expert Committee is established by the WHO World Health Assembly or by an Executive Board decision. It is governed through rules and procedures that are strictly adhered to. ECSPP was established at the first World Health Assembly, in 1948, to provide recommendations and tools to ensure the quality of medicines: from their development phase to their final distribution to patients. The development of norms, standards and guidelines to promote quality assurance and quality control is an integral part of WHO’s Constitution and a unique responsibility.

Guidelines relating to medicines quality assurance are drafted by pharmaceutical specialists, in consultation with the WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations, other specialists from industry, national institutions and nongovernmental organizations. Preparation of guidelines generally incorporates an extensive consultative procedure. The draft guidelines are evaluated by ECSPP at its annual meeting. If considered to be appropriate they are adopted as international standards. Alternatively, ECSPP may request that a draft guideline be revised.

The WHO Technical Report Series includes all guidelines that have been adopted by ECSPP. They are appended as annexes to ECSPP’s annual reports, each of which is published as a WHO Technical Series report. Many of these annexes underpin the procedures and activities of WHO medicines prequalification and therefore serve as valuable references for manufacturers, regulators and procurers. For example, Annex 2 of WHO Technical Report Series 957, WHO Expert Committee on Specifications for Pharmaceutical Preparations, Forty-fourth Report (published in 2010) concerns WHO good manufacturing practices (GMP) for active pharmaceutical ingredients. WHO inspections of the manufacturing sites of active pharmaceutical ingredients and finished pharmaceutical products, undertaken as a component of evaluation for WHO prequalification, are based on WHO GMP.

WHO Technical Report Series documents relating to development, production, distribution, inspection and quality control of medicines can be found on the guidelines section of the WHO web pages dealing with quality assurance of medicines. The guidelines most relevant to WHO medicines prequalification are listed and accessible below. The full Technical Report Series documents issued by the WHO Expert Committee on Specifications for Pharmaceutical Preparations are publicly available.

 

WHO TRS documents relevant to prequalification

WHO prequalification requirements for active pharmaceutical ingredients and finished pharmaceutical products

Guidelines on active pharmaceutical ingredient master file procedure (2008)
WHO Technical Report Series, No. 948, Annex 4, 2008

Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part (2012)
WHO Technical Report Series, No. 970, Annex 4, 2012

Guidelines on submission of documentation for a multisource (generic) finished product. Preparation of product dossiers in common technical document format (2011)
WHO Technical Report Series, No. 961, Annex 15, 2011

Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities (2014)
WHO Technical Report Series, No. 986, Annex 5, 2014

Guidelines on variations to a prequalified product (2013)
WHO Technical Report Series, No. 981, Annex 3, 2013

Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products (2009)
WHO Technical Report Series, No. 953, Annex 4, 2009

Procedure for prequalification of pharmaceutical products (2011)
WHO Technical Report Series, No. 961, Annex 10, 2011


WHO prequalification requirements for quality control laboratories

Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies (2011)
WHO Technical Report Series, No. 961, Annex 12, 2011


Bioequivalence

Guidance for organizations performing in vivo bioequivalence studies (revision) (2016)
WHO Technical Report Series, No. 996, Annex 9, 2016

Guidelines for registration of fixed-dose combination medicinal products (2005)
WHO Technical Report Series, No. 929, 2005, Annex 5

Guidelines on registration requirements to establish interchangeability (2015)
WHO Technical Report Series, No. 992, Annex 7, 2015

Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (2015)
WHO Technical Report Series, No. 992, Annex 8, 2015


Clinical trials

Guidelines for good clinical practice for trials on pharmaceutical products (1995)
WHO Technical Report Series, No. 850, Annex 3, 1995


Collaborative procedure

Collaborative procedure between the World Health Organization (WHO) Prequalification Team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines (2016)
WHO Technical Report, Series No. 996, Annex 8, 2016


Good manufacturing practices

Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals (2003)
WHO Technical Report, Series No. 908, Annex 7, 2003

Good manufacturing practices for active pharmaceutical ingredients (2010)
WHO Technical Report, Series No. 957, Annex 2, 2010

Good manufacturing practices for biological products (2016)
WHO Technical Report Series, No. 996, Annex 3, 2016

Good manufacturing practices for pharmaceutical products containing hazardous substances (2010)
WHO Technical Report Series, No. 957, Annex 3, 2010

Good manufacturing practices for pharmaceutical products: main principles (2014)
WHO Technical Report Series, No. 986, Annex 2, 2014

Good manufacturing practices for radiopharmaceutical products (2003)
WHO Technical Report Series, No. 908, Annex 3, 2003

Good manufacturing practices for sterile pharmaceutical products (2011)
WHO Technical Report Series, No. 961, Annex 6, 2011

Good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans (1996)
WHO Technical Report Series, No. 863, Annex 7, 1996

Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients (1999)
WHO Technical Report Series, No. 885, Annex 5, 1999

Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (2011)
WHO Technical Report Series, No. 961, Annex 5, 2011

Supplementary guidelines on good manufacturing practices: validation (2006)
WHO Technical Report Series, No. 937, Annex 4, 2006

Good manufacturing practices: water for pharmaceutical use (2012)
WHO Technical Report Series, No. 970, Annex 2, 2012

Model certificate of good manufacturing practices (2003)
WHO Technical Report Series, No. 908, Annex 5, 2003

Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients (2015)
WHO Technical Report Series, No. 992, Annex 6, 2015


Inspections

Guidance on good data and record management practices (2016)
WHO Technical Report Series, No. 996, Annex 5, 2016

Guidance on good manufacturing practices: inspection report (2016)
WHO Technical Report Series, No. 996, Annex 4, 2016

Guidelines for drafting a site master file (2011)
WHO Technical Report Series, No. 961, Annex 14, 2011

Guidelines for inspection of drug distribution channels (1999)
WHO Technical Report Series, No. 885, Annex 6, 1999

Guidelines on pre-approval inspections (2002)
WHO Technical Report Series, No. 902, Annex 7, 2002

Guidelines for preparing contract research organization master file (2010)
WHO Technical Report Series, No. 957, Annex 7, 2010

Model certificate of good manufacturing practices
WHO Technical Report Series, No. 908, Annex 5, 2003

Provisional guidelines on the inspection of pharmaceutical manufacturers (1992)
WHO Technical Report Series, No. 823, Annex 2, 1992

Quality system requirements for GMP inspectorates (2002)
WHO Technical Report Series, No. 902, Annex 8, 2002


Good practices for pharmaceutical quality control laboratories

Boas práticas da OMS para laboratórios de controle de qualidade de produtos farmacêuticos (2010)
OMS Serie de Informes Técnicos, No. 957, Anexo 1, 2010

Buenas prácticas de la OMS para laboratorios de control de calidad de productos farmacéuticos (2010)
OMS Serie de Informes Técnicos, No. 957, Anexo 1, 2010

Buenas prácticas de la OMS para laboratorios de microbiología farmacéutica
OMS Serie de Informes Técnicos, No. 961, Anexo 2, 2011

Directives pour la préparation d'un dossier d'information par le laboratoire (2011)
OMS Série de Rapports techniques, No 961, Annexe 13, 2011

Good practices for pharmaceutical microbiology laboratories (2011)
WHO Technical Report Series, No. 961, Annex 2, 2011

Good practices for pharmaceutical microbiology laboratories (2011) in Thai (2010)
WHO Technical Report Series, No. 957, Annex 1, 2010

Good practices for pharmaceutical quality control laboratories (2010)
WHO Technical Report Series, No. 957, Annex 1, 2010

Guidelines for preparing a laboratory information file (2011)
WHO Technical Report Series, No. 961, Annex 13, 2011

Régles de bonne pratique applicables par les laboratoires de contrôle qualité pharmaceutique (2010)
OMS Série de Rapports techniques, No 957, Annexe 1, 2010

 


Quality control and testing

Considerations for requesting analysis of drug samples (2002)
WHO Technical Report Series, No. 902, Annex 4, 2002

General guidelines for the establishment, maintenance and distribution of chemical reference substances (2007)
WHO Technical Report Series, No. 943, Annex 3, 2007

Guidelines for sampling of pharmaceutical products and related materials (2005)
WHO Technical Report Series, No. 929, Annex 4, 2005

Guidelines on the conduct of surveys of the quality of medicines (2016)
WHO Technical Report Series, No. 996, Annex 7, 2016

Model certificate of analysis (2002)
WHO Technical Report Series, No. 902, Annex 10, 2002


Procurement and procurement agencies

Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection (2014)
WHO Technical Report Series, No. 986, Annex 4, 2014

Guide to good storage practices for pharmaceuticals (2003)
WHO Technical Report Series, No. 908, Annex 9, 2003

Guidelines for the preparation of a procurement agency information file (2003)
WHO Technical Report Series, No. 917, Annex 7, 2003

Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (2011)
WHO Technical Report Series, No. 961, Annex 9, 2011

Model quality assurance system for procurement agencies (2014)
WHO Technical Report Series, No. 986, Annex 3, 2014

Outil d’évaluation des AA fondé sur le Système modèle d’assurance de la qualité pour AA : aide-mémoire pour les inspections (2014)
OMS Série de Rapports techniques, No 986, Annexe 4, 2014

Procedure for assessing the acceptability, in principle, of procurement agencies for use by UN agencies (2003)
WHO Technical Report Series, No. 917, Annex 6, 2003

Système modèle d’assurance de la qualité pour agences d'approvisionnement (2014)
OMS Série de Rapports techniques, No 986, Annexe 3, 2014


Other

Guidelines for registration of fixed-dose combination medicinal products (2005)
WHO Technical Report Series, No. 929, Annex 5, 2005

Guidelines on quality risk management (2013)
WHO Technical Report Series, No. 981, Annex 2, 2013

Guidelines on transfer of technology in pharmaceutical manufacturing (2011)
WHO Technical Report Series, No. 961, Annex 7, 2011

Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (2015)
WHO Technical Report Series, No. 992, Annex 7, 2015

Stability conditions for APIs and FPPs (updated March 2015)
WHO Technical Report Series, No. 953, Annex 2, updated March 2015