For example, in haiti in 1996, more than 80 children died after. Annex 5 good distribution practices for pharmaceutical products 179 annex 6. Validation of water systems for pharmaceutical use appendix 3. Trs 885 annex 5 guidelines on good manufacturing practices for radiopharmaceutical products trs 908 annex 3 2003 supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines trs 937 annex 3 2006 guidelines on validation includes 7 appendices appendix 4. Jul 31, 2015 trs 986 2014 annex 2 who gmp for pharmaceutical products main principles 1. 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 airconditioning systems for nonsterile pharmaceutical dosage forms annex 5, who technical report series 961,2011. Annex 8 sampling of starting and packaging materials principle sampling is an important operation in which only a small fraction of a batch is taken.
New who trs 992 may 2015 having guidance on hold time. Trs 986 2014 annex 2 who gmp for pharmaceutical products main principles 1. Tak003 elicited antibody responses against all four serotypes, which persisted to 48 months postvaccination, regardless of baseline serostatus. Safety and immunogenicity of a tetravalent dengue vaccine in. Appendix 5 examples of use of sampling plans n, p and r 93. Comparison of eu gmp guidelines with who guidelines identification of the costintensive requirements. World health organization who provides the gmp guidelines for pharmaceuticals. The who additionally describes further general requirements in its introduction of annex 3, technical report series trs 961, quality management in the medicines industry.
The european commission mandated esma on 11 october 2012 to provide it with technical advice on the equivalence between the us regulatory regime and different aspects of the eu regulatory regime. Who trs t e c h n i c a l r e p o r t s e r i e s 992 was released in may2015 by who. Who expert committee on specifications for pharmaceutical. Progress and challenges of parametric release applied to. Hvac for nonsteriles, transportation, stability, reference substances, quality terms, qc labs qualification, trs 943. Publication of the updated who stability guideline trs. World health organization, 2005, annex 5 who technical report series, no. Recently who trs 961 has published the updated contents on gmp in annex 3. The technical supplement series this series of technical supplements has been written to amplify the recommendations given in model guidance for the storage and transport of time and temperaturesensitive pharmaceutical products who technical report series, no. Annex 4 who good manufacturing practices for sterile pharmaceutical products introduction the who expert committee on speci. Guidelines for registration of fixeddose combination medicinal products. Annex 4, 2006 and as crossreference to trs 970, annex 2, 2012 5.
Ms yukiko maruyama presented a document titled proposed who guidelines for. Technical report series trs, with the adopted guidelines as annexes. Technical advice on third country regulatory equivalence. Appendix 3 steps to be considered for inclusion in a standard operating procedure. Geneva, world health organization 2005 who technical report series, no. Annex 3 good practices for national pharmaceutical control. Global bioequivalence bioavailability regulatory guidance. Balancing the advantages and disadvantages of a new. Draft report on enzyme assessment for jecfa food additives 23 58.
Annex 10 stability testing of active pharmaceutical ingredients and finished pharmaceutical products introduction and background the guidance on stability testing of active pharmaceutical ingredients and finished pharmaceutical products was published as annex 2 in the world health organization who technical report series, no. Pharmaceutical development pharmaceutical formulation. Guidelines on import procedures for medicinal products revision annex 5 clicking here takes you directly to trs 1019, that summarises and interprets all results of the 53nd whoexpertmeeting of october 2018 in geneva. Annex 6 who good manufacturing practices for sterile pharmaceutical products. Annex 4 who guidelines for sampling of pharmaceutical. Who good manufacturing practices for biological products. Guidance on compatibility studies is provided in appendix 3 of. We assessed the immunogenicity and safety of three different dose schedules of a tetravalent dengue vaccine tak003 over a 48month period in children living in dengueendemic countries. The appendix to part 745 is amended by removing section b and by redesignating sections c through g as b through f respectively. Validation of computerized systems update in process. Ich q1a, b, c, d and e variation guidance appendix 4 stability requirements for variations trs 943 guideline on stability testing for applications for variations to a marketing authorization ema 2011 fdc guideline trs 929 annex 5. Annex 4 supplementary guidelines on good manufacturing.
Who technical report series who technical report series 957 957who expert committee who expert committee on specifications for on specifications for pharmaceutical preparations pharmaceutical preparations fortyfourth report fortyfourth report the world health organization was established in 1948 as a specialized agency of the united nations serving as the directing. Joint faowho expert committee on food additives expert. Interregional seminar for quality control laboratories involved in who prequalification programme andor participating in respective sampling and testing projects, nairobi, kenya, 2325 september 2009. Who good practices for pharmaceutical quality control laboratories. Out of these annexure, annex 3 guidelines on good manufacturing practices. Annex 5 guidance on good data and record management practices background during an informal consultation on inspection, good manufacturing practices and risk management guidance in medicines manufacturing held by the world health organization who in geneva in april 2014, a proposal for. These guidelines are followed through out the world. The updated who stability guideline has now been published in trs 1010 annex 10.
Proposal to waive in vivo bioequivalence requirements for who model list of essential medicines immediate. Annex 4 recommendations for the production, control and. Stability conditions for who member states by region, in appendix 1 to the. An unmet clinical need remains for an effective tetravalent dengue vaccine suitable for all age groups, regardless of serostatus. This annex deals with the collection and storage of reference samples of starting materials, packaging materials and retention samples of finished products. Finished pharmaceutical products fppcopenhagen, denmark 2225 september 2014 1 vimal sachdeva, technical officer inspector. Stability testing of active pharmaceutical ingredients and finished pharmaceutical. Who technical report series who prequalification of. The guidelines most relevant to who medicines prequalification are listed and accessible below. Who expert committee on specifications for pharmaceutical preparations. Appendix 3, part a that the applicant is acting for, or pursuant to rights derived from, the who pq holder, and that the pq holder agrees with the application of the procedure in the country concerned. Annex 4 who good manufacturing practices for sterile.
Bioavailabilitybioequivalence, gcpglp, dissolutionbcs, pharmacokinetics, bioanalytics and statistics. An example of the steps to be considered when sampling. Supplementary training modules on good manufacturing practice who technical report series, no. Stability considerations in the life cycle of generic. Roomsee figures 3, 4, and 5, of appendix b, for sample closet layouts. Supplementary training modules on good manufacturing practice. Results from this study provide a longterm safety database and support assessment of the vaccine in the ongoing. Annex 5 guidelines for stability testing of pharmaceutical. The final guidelines are listed in form of annexes and will be published on the who website in form of single documents. Valid conclusions on the whole cannot be based on tests which have been carried out on nonrepresentative samples.
Who good manufacturing practices for sterile pharmaceutical products who trs 961, annex 6 free pdf download. Appendix 2 consent of who prequalification holder for who to. Bibliography appendix 1 types of sampling tools appendix 2 sample collection form appendix 3 steps to be considered for inclusion in a standard operating procedure. Who guidelines including gmp guidelines for process validation, cleaning validation, analytical method validation, hvac validation, water system validation and stability. Information required for the safety assessment of enzyme preparation 61. Appendix 2 donor selection appendix 3 donor immunization and plasmapheresis for speci. Annexes 1 3 of that appendix specify the central and subcentral government entities as well as other entities, such as public utilities, that each party has committed to complying with the agreement. Each partys appendix i annexes also specify the minimum threshold values above which a procurement is. Supplementary training modules on good manufacturing. Annex 3 good practices for national pharmaceutical control laboratories general considerations 28 glossary 29 part one. Appendix 4 examples of types of containers used to store samples of starting materials and bulk products appendix 5 examples of use of sampling plans n, p and r. This presentation is compiled by drug regulations a non profit organization which provides free online resource to the pharmaceutical professional.
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. Comparison of eu gmp guidelines with who guidelines. Annex 5 basic elements of good manufacturing practices in. Definitions for safe food enzyme production strain and presumed safe 59. Ufc 358001 the whole building design guide pages 1 45. Pharmaceutical development who guidelines trs 929 annex 5. Guidelines on import procedures for medical products. Geneva, world health organization, 2005 who technical report series, no. Annex 3 who good manufacturing practices for biological products replacement1 of annex 1 of 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. Although this collection contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. We observed a longterm reduction in risk of symptomatic dengue virus disease in vaccinees.
Correct sampling is thus an essential part of a system of quality assurance. Good manufacturing practices for pharmaceutical products. Progress and challenges of parametric release applied to pharmaceuticals humberto zardo, bs ind pharm, msc consultant irvine, ca usa ii symposium sindusfarma anvisa fipips new frontiers in manufacturing technology, regulatory sciences and pharmaceutical quality system. Generics guideline stability testing of apis and fpps who stability guide in trs953 2009 annex 2. Annex 4 recommendations for the production, control. Who trs 937annex4 verification and validation calibration.
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