Trs 961, annex 15 published in 2011 quality overall summary qos. Who trs 1010, annex 8, guidelines on hvac systems for nonsterile pharmaceutical products the present document is the first part and contains the recommendations that are to be considered as. 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. Guidelines on submission of documentation for a multisource generic finished pharmaceutical product.
Dates of inspection 37 june 2019 type of inspection routine gmp inspection of the facility for bulk artesunate sterile powder sterile api and that for the powder for injection fpp only. Temperature and humidity monitoring systems for fixed storage areas 7. T h i s p r i n t i n g p u b l i s h e s a r e v i s i o n o f t h i s p u b l i c a t i o n. Water for pharmaceutical use annex 2, who technical report series 970, 2012. Jul 31, 2015 trs 986 2014 annex 2 who gmp for pharmaceutical products main principles 1. Trs 986 2014 annex 2 who gmp for pharmaceutical products main principles 1. Comparison of guidelines of indian gmp with who gmp. Trs 961 2011 annex 6 who gmp for sterile pharmaceutical.
Model certificate of good manufacturing practices who technical report series, no. Who good manufacturing practices for pharmaceutical products. Int mylan laboratories limited, unit 2 telangana india desk assessment api 07 october 2019. Control of the quality of water throughout the production, storage and dis tribution. Annex 4 who good manufacturing practices for sterile pharmaceutical products introduction the who expert committee on speci. Results from this study provide a longterm safety database and support assessment of the vaccine in the ongoing. Who trs97046th2012 free ebook download as pdf file. Guidelines on variations to a prequalified product trs 981 annex 3 use of ich q3d guideline in the assessment of active pharmaceutical ingredients master files apimfs. Page 2 of 5 list of gmp guidelines, their titles of publication and web addresses 1. Publication of the updated who stability guideline trs. Quality system requirements for gmp inspectorates 2002. Who expert committee on biological standardization sixtyfourth report 6 2. A new drat guideline will address the development and manufacturing of active pharmaceutical ingredients apis including chemical, biotechnological and biological entities. Who trs 970 46th2012 free ebook download as pdf file.
Aseptic processing and sterilization by filtration 88 8. Trs 937, annex 4, 2006 and as crossreference to trs 970, annex 2. Security and fire protection in storage facilities 5. Who trs other useful guidances along with pq quality guidelines, other who guidelines and points to consider are published in the trs. Tak003 elicited antibody responses against all four serotypes, which persisted to 48 months postvaccination, regardless of baseline serostatus. Provisional guidelines on the inspection of pharmaceutical manufacturers 1992 who technical report series, no. Safety and immunogenicity of a tetravalent dengue vaccine in. Guidelines on submission of documentation for a multisource generic finished pharmaceutical product for the who. Pharmaceutical development of multisource generic pharmaceutical products point to consider 20 annex 3 trs 970.
Who expert committee on specifications for pharmaceutical preparations a thirtyninth report this report presents the recommendations of an international group of experts convened by the world health organization to consider matters concerning the quality assurance of pharmaceuticals and speci. Jul 17, 2015 trs 961 2011 annex 6 who gmp for sterile pharmaceutical products. Expendabledurable items except medical, class v, repair. Some nonpq guidelines that provide supportive guidance. Jun 21, 2018 who trs 1010, annex 8, guidelines on hvac systems for nonsterile pharmaceutical products the present document is the first part and contains the recommendations that are to be considered as. Who expert committee on specifications for pharmaceutical preparations fortysixth report.
World health organization who provides the gmp guidelines for pharmaceuticals. It was subsequently submitted to the twentyfirst world health assembly under the title draft requirements for good. The updated who stability guideline has now been published in trs 1010 annex 10. Who expert committee on specifications for pharmaceutical. These measures are intended to promote effective and efficient processes. Annex 2 2012 970 gmp for water for pharmaceutical use. Annex 4 123 fully adopt the modular format of the common technical document quality m4q 2 as developed by ich. Results from this study provide a longterm safety database and support assessment of the vaccine in. Annex 1, followed by a series of who guidelines adopted on the advice of the committee annexes 24. B e c a u s e t h e p u b l i c a t i o n h a s b e e n e x t e n s i v e l y r e v i s e d. Expendabledurable items except medical, class v, repair parts, and heraldic items common table of allowance 50970 h i s t o r y. We observed a longterm reduction in risk of symptomatic dengue virus disease in vaccinees. Validation of water systems for pharmaceutical use as published in trs 937, annex 4, 2006 and as crossreference to trs 970, annex 2, 2012. Oct 28, 2018 b d n om ri petunjuk teknis sarana penunjang kritis industri farmasi juknis spk 1 cpob 2 badan pengawas obat dan makanan republik indonesia 2 farmarind.
On the other hand, preschoolaged children are not included in who guidelines for schistosomiasis control because the safety of praziquantel in children under 4 years of age has not been. Publication of the updated who stability guideline trs 1010. Mar 11, 2015 process validation commitment as described in annex 4,trs 970, applicants are not expected to have process validation data before pq in this case satisfactory pv protocol pvp and appropriately worded commitment are essential pvp or signed commitment letter should clearly indicate the need for prospective validation as finalized on three. Good manufacturing practices for premises and materials who gmp who good manufacturing practices for pharmaceutical products. Quality assessment procedure is publicly available. All additions and discontinuations made during the 20 meeting to. Annex 6 good manufacturing practices for sterile pharmaceutical products introductory note 76 1. 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.
Annex 2 79 introduction the first who draft text on good manufacturing practices gmp was prepared in 1967 by a group of consultants at the request of the twentieth world health assembly resolution wha20. Comparison of guidelines of indian gmp with who gmp section wise comparison contd indian gmp, schedule m who gmp 11 general requirements 1. Who technical report series who prequalification of. Standard requirement of a microbiological quality control. Who expert committee on specifications for pharmaceutical preparations. Safety and immunogenicity of a tetravalent dengue vaccine. B d n om ri petunjuk teknis sarana penunjang kritis industri farmasi juknis spk 1 cpob 2 badan pengawas obat dan makanan republik indonesia 2 farmarind. Finished pharmaceutical products fppcopenhagen, denmark 2225 september 2014 1 vimal sachdeva, technical officer inspector. The expert committee on specifications for pharmaceutical preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines.
Pdf treatment of preschool children for schistosomiasis. Signup for the free email updates for your daily dose of pharmaceutical tipsmoc. Annex 4 who good manufacturing practices for sterile. These guidelines are followed through out the world. This guideline replaces the previous stability guideline in trs 953 annex 2 2009, which is referred to in the pq quality technical guidelines trs 970 annex 4. Who good manufacturing practices for pharmaceutical. Development of monographs for the international pharmacopoeia. Annex 1 release procedure of international chemical reference substances 67 annex 2 who good practices for. Water for pharmaceutical use, annex 2, trs 970, 2012. Annex 4, 2006 and as crossreference to trs 970, annex 2, 2012 5. 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.
Trs 961 2011 annex 6 who gmp for sterile pharmaceutical products. Process validation commitment as described in annex 4,trs 970, applicants are not expected to have process validation data before pq in this case satisfactory pv protocol pvp and appropriately worded commitment are essential pvp or signed commitment letter should clearly indicate the need for prospective validation as finalized on three. Annex 4, who technical report series 986, 2014 selfinspection tool. 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. Interpretation of guidelines on heating, ventilation and airconditioning systems for nonsterile pharmaceutic al products. Annex 2 2012 970 gmp for water for pharmaceutical use free download as pdf file. Fifty third report geneva, world health organization, 2019 who technical report series, no. On the other hand, preschoolaged children are not included in who guidelines for schistosomiasis control because the safety of praziquantel in children under 4 years of. Comparison of guidelines of indian gmp with who gmp main requirements indian gmp, schedule m schedule m, part. Gmpwatepharmaceuticalusetrs970annex2 drinking water.
Gmpwatepharmaceuticalusetrs970annex2 drinking water water. Whether the association between the establishment of an adi and the presence of the 495 enzyme preparation in the final food can be considered unnecessary and reference to 496 the adi can be deleted from the text in ehc 240 chapter 9. Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a major concern. Annex 6 who good manufacturing practices for sterile pharmaceutical products. Who expert committee on biological standardization sixtythird report. Standards are developed by the committee through worldwide consultation and an international consensusbuilding process. Int macleods pharmaceuticals limited, daman, indiafpp 37 june 2019 this inspection report is the property of the who contact. Who technical report series trs 970, 2012 read in english 45th report who technical report series trs 961, 2011 read in english. Int mylan laboratories limited, unit 2 telangana india desk assessment api 07 october 2019 this inspection report is the property of the who. Annex 3 pharmaceutical development of multisource generic. Prequalification of generic drug products trs 970 annex 4 guidance on amendments to apis. Scribd is the worlds largest social reading and publishing site.
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