Annex 2 51 introduction who requirements for oral poliomyelitis vaccine opv were first formulated in 1962 1, and revised in 1965 2, and then again in 1971 3, when an appendix describing the production of opv in human diploid cells was added. The requirements were further updated in 1982 4 following an accumulation. Global bioequivalence bioavailability regulatory guidance. Annex 2 national control laboratory for biologicals. Jul 17, 2015 these changes were adopted for maintenance purposes. Trs 961 2011 annex 6 who gmp for sterile pharmaceutical products. Comparison of guidelines of indian gmp with who gmp. Int piramal healthcare uk desk assessment api 12 september 2019 this inspection report is the property of the who contact. Control of the quality of water throughout the production, storage and dis tribution. Who good manufacturing practices for sterile pharmaceutical products 1. S section for the api from each of the other api manufacturers.
Who guideline pharmaceutical guidance pharmaceutical guidance. Gmpwatepharmaceuticalusetrs970annex2 free download as pdf file. Who technical report series trs 992, 2015 read in english 48th report who technical report series trs 986, 2014 read in english 47th report who technical report series trs 981, 20 read in english 46th report who technical report series trs 970, 2012 read in english 45th report who technical report series trs 961, 2011 read in english 44th report. Submitted acceptable, prepared according to the who trs no. Geneva, world health organization, 2006 who technical report series, no. Cleaning validation as published in trs and trs 937, annex 4, 2006 and as crossreference to trs 970, annex 2, 2012 5 appendix 4. Who guidelines are known as who trs technical report series. Mar 31, 2016 water for pharmaceutical use annex 2, who technical report series 970,2012 who guidelines on good manufacturing practices for heating, ventilation and airconditioning systems for nonsterile pharmaceutical dosage forms annex 5, who technical report series 961,2011. Geneva, world health organization, 2014 who technical report series, no. Mcaz good manufacturing practice guideline medicines control. Annex 2 international pharmaceutical federation fip.
Trs 961 2011 annex 6 who gmp for sterile pharmaceutical products cong ty c. Annex 4, 2006 and as crossreference to trs 970, annex 2, 2012 5. Opening remarks by secretary of the expert committee 2 general 2 developments in biological standardization 2 who programmatic issues 2 vaccines and biological therapeutic products 4 maintenance of capacity for production of mcr5 human diploid. Annex 5 201 infants and toddlers 28 days23 months children 2 11 years adolescents 12 to 1618 years dependent on region. The world health organization was established in 1948 as a specialized agency of the united nations serving as the directing and coordinating authority for international health matters and public health. In order to ease reading the full guideline has been reproduced again as an annex to the current report of thewho expert committee on speci. Cleaning validation as published in trs and trs 937, annex 4, 2006 and as crossreference to trs 970, annex 2, 2012 5. Trs 961 2011 annex 6 who gmp for sterile pharmaceutical. Scribd is the worlds largest social reading and publishing site. Temperature and humidity monitoring systems for fixed storage areas 7. Fortyeighth report geneva, world health organization, 2014 who technical report series, no. Joint session with the expert committee on biological standardization 4. Replacement of annex 1 of who technical report series, no. Int piramal healthcare uk desk assessment api 12 september 2019.
The who technical report series makes available the findings of various. Gmpwatepharmaceuticalusetrs970annex2 drinking water water. Annex 3 requirements for measles, mumps and rubella vaccines. Who good manufacturing practices for biological products.
Who trs970 46th2012 free ebook download as pdf file. Guideline on stability testing of existing active substances. Hvac for nonsteriles, transportation, stability, reference substances, quality terms, qc labs qualification, trs 943. Who expert committee on specifications on pharmaceutical. Trs 961, annex 15 published in 2011 quality overall summary qos. Who expert committee on specifications for pharmaceutical preparations. Annex 4 123 fully adopt the modular format of the common technical document quality m4q 2 as developed by ich.
Annex 3 pharmaceutical development of multisource generic. It is a challenge to find one formulation appropriate for all age groups. Annex 3 requirements for measles, mumps and rubella. Unlike other product and process ingredients, water is usually drawn from a system on demand, and is not subject to testing and batch or lot release before use. Summary and recommendations acknowledgements annex 1 release procedure of international chemical reference substances annex 2 who good practices for. Who expert committee on specifications for pharmaceutical. These measures are intended to promote effective and efficient processes. World health organization, regional office for the eastern mediterranean.
Annex 2 recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines oral, live, attenuated replacement of annex 1 of who technical report series, no. Who trs 937annex4 verification and validation calibration. Security and fire protection in storage facilities 5. Trs 970 annex 2, 46th report, 2012 reg regularly campode accionpara ensayosy mejoras. Quality control specifications and tests for the international pharmacopoeia 14 2. Who good manufacturing practices for pharmaceutical products. Validation of water systems for pharmaceutical use as published in trs 937, annex 4, 2006 and as crossreference to trs 970, annex 2, 20125 appendix 3. Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a major concern. Guidance for organizations performing in vivo bioequivalence studies. Trs 957 2010 annex 3 who gmp for pharmaceutical products containing hazardous substances.
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