WHO Guideline

WHO GUIDLINE FOR PRODUCTION

WHO good manufacturing practices

WHO good manufacturing practices for pharmaceutical products: main principles(Annex 2, WHO Technical Report Series 986,2014)

Active pharmaceutical ingredients (bulk drug substances) (Annex 2, WHO Technical Report Series 957,2010)

Pharmaceutical excipients (Annex 5, WHO Technical Report Series 885,1999)

WHO good manufacturing practices for sterile pharmaceutical products (Annex 6, WHO Technical Report Series 961,2011)

Biological products (Annex 3, WHO Technical Report Series 822,1992)

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)

Investigational pharmaceutical products for clinical trials in humans (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 (Annex 2, WHO Technical Report Series 970,2012)

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 (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)

                                   

                             WHO GUIDELINE LINK FOR QUALITY CONTROL

Screening tests (Basic tests for drugs : pharmaceutical substances, medicinal plant materials and dosage forms)

Pharmacopoeia and International Reference Standards

Index of national, regional and international pharmacopoeias

Release procedure for International Chemical Reference Substances (Annex 1, WHO Technical Report Series 981,2013)

Procedure for the development of monographs and other texts for The International

Pharmacopoeia (Annex 1, WHO Technical Report Series 992, 2015)

Recommendations on Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products (Annex 1, WHO Technical Report Series 908, 2003)

The International Pharmacopoeia: revised concepts and future perspectives (Annex 2, WHO Technical Report Series 908, 2003)

The International Pharmacopoeia – related substances tests: dosage form monographs guidance notes (Annex 1, WHO Technical Report Series 943, 2007)

General guidelines for the establishment, maintenance and distribution of chemical reference substances (Annex 3, WHO Technical Report Series 943, 2007)

PowerPoint presentation on the International Pharmacopoeia

Analysis of Samples

Considerations for requesting analyses of drug samples (Annex 4, WHO Technical Report Series 902, 2002)

Model certificate of analysis (Annex 10, WHO Technical Report Series 902, 2002)

Laboratory Guidelines

Good practices for pharmaceutical quality control laboratories(Annex 1, WHO Technical Report Series 957, 2010)

WHO good practices for pharmaceutical microbiology laboratories (Annex 2, WHO Technical Report Series 961, 2011)

Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies (Annex 12, WHO Technical Report Series 961, 2011)

WHO guidelines for preparing a laboratory information file (Annex 13, WHO Technical Report Series 961, 2011)

Plant materials

Quality control methods for medicinal plant materials

 

The International Pharmacopoeia (Ph. Int.) – monograph development

To consult current work plan click here

Process: Steps followed in the development of new Monographs

General monographs

Capsules 

Tablets 

General methods

Sulfated ash

Sterility test

Microbial examination of non-sterile products : microbial enumeration tests

Microbial examination of non-sterile products: test for specified microorganisms

Test for bacterial endotoxins 

Uniformity of content for single-dose preparations

 Disintegration test for tablets and capsules

Extractable volume for parenteral preparations (revision)

Tests for particulate contamination

Tablet friability

Bulk density and tapped density of powders

Microbiological quality of non-sterile products: recommended acceptance criteria for pharmaceutical preparations

 

GENERAL GUIDANCE FOR INSPECTORS ON “HOLD-TIME” STUDIES ( DRAFT )

 

General guidance on hold-time studies (TRS 992, Annex 4)

 

Non‑sterile process validation Annex3-TRS992

 

 

 

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