Presentation on eu gmp annex 16 certification by qp 1. Documented evidence that the process, operated within established. Airborne particle counting for pharmaceutical facilities. Replacement of commission directive 956ec of june 1991 to cover good manufacturing practice of investigational medicinal products. The eu logo on the left on the bottom of each page is a reminder of the origin of this document. How will it affect my operation or the company as a whole. When the draft was publicised back in february 2014, we at pharmout scrutinised the document and produced a white paper detailing the proposed changes in this article, i will discuss the changes. European union, volume 4, good manufacturing practice, medicinal products for human and veterinary use diverges in philosophy. European commission directorategeneral for health and food safety medicinal products quality, safety and efficacy brussels, 30 march 2015 eudralex volume 4 eu guidelines for good manufacturing practice for medicinal products for human and veterinary use annex 15. Ich guideline q9 on quality risk management emachmpich242352006 page 4 20 lifecycle of drug substances, drug medicinal products, biological and biotechnological. Working party on control of medicines and inspections final.
Gmp that manufacturers identify what validation work is needed to prove. However, the approach of part 11 is to make clear there are requirements to be met in order to conform to regulations. Chapter 7 final version 11102011 european commission. Volume iv good manufacturing practice gmp guidelines. Volume iv gmp regulations, it is important to take in the wider picture. The attention of states is also drawn to the provisions of annex 15 related to the. Regulations have binding legal force in every member state ms. Implementation of gmp in early phase clinical trials.
This annex deals with the collection and storage of reference samples of starting materials, packaging materials and retention samples of finished products. Volume 4 of the rules governing medicinal products in the european union contains guidance for. New eu gmp for atmps vs existing gmps pros and cons drew hope director of quality operations, autolus. Qualification and validation into operation since 1 october 2015. This annex is specific to the eu gmp guide and has not been adopted by pics. Both documents cover the same topic, the use of computerized systems in regulated activities. This presentation is compiled by drug regulations a non profit organization which provides free online resource to the pharmaceutical professional. This annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to eudralex, volume 4, part ii. Draft annex 15 v12 200115 for pics and ec adoption.
All human and veterinary api and finished product medicines. Annex 15 was originally published in september 2001, and since then there have been significant changes in the gmp environment with the incorporation of ich q9 and q10. In january 2011, the eu issued a revision to annex. Volume 4 of the rules governing medicinal products in the european union contains. The draft version is based on an ema concept paper, published in november 2012 which outlined various reasons for the revision of annex 15. New eu gmp annex 15 revision published valid as of 1 october 2015 02042015.
Detailed guidance of annex clinical labeling requirements are detailed in annex of the eu gmp guide eudralex volume iv of the rules, articles 26 33 each of these articles have been reprinted in. The following guideline can be ordered through the address listed in the sourcepublishercategory. New revised eu gmp annex 11 ispe international society. Eudralex the rules governing medicinal products in the european union volume 4 eu guidelines to good manufacturing practice medicinal products for human and veterinary use annex 1. Good manufacturing practices for medicinal products for human use.
Eu gmp annex 1 is the primary document governing the manufacture, control and release of sterile pharmaceutical products both terminally sterilised and aseptically filled medicines. Gmp publications, basic eu gmps with annex 11, 15, 16, 18, 19. European commission, health and consumers directorategeneral. Update 2008, eu gmp annex 1 lighthouse worldwide solutions on february 14th, 2008, the european commission updated volume 4 eu guidelines to good manufacturing practice medicinal products for human and veterinary use. The ec through annex 11 of gmp and fda through the us 21 cfr part 11. The impact on microbial id strategy on cleanroom qualifications for pharma manufacturers. Presentation on eu gmp annex 16 certification by qp. In cases in which you can order through the internet we have established a hyperlink.
Volume 4 eu guidelines for good manufacturing practice for. Eudralex volume 4 good manufacturing practice gmp guidelines part i basic requirements for med. Eu gmp requirements validation at turkish ministry of health ankara, 2021 oct 2009. Good manufacturing practices for medicinal products for. Reflection paper on good manufacturing practice and marketing authorisation holders. Article 631 of regulation eu no 53620143 also empowers the commission to adopt and publish detailed guidelines on good manufacturing practice applicable to investigational medicinal products. It is not meant to address all changes within the revision. Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these systems. I start to read the intro below the headline again. In february 2014 the draft for the revision of eu gmp annex 15 was published see the gmp news from 11 february 2014 revision of the eu gmp annex 15 for qualification and validation published. Questions and answers covering interpretation of chapter.
Eudralexeu guidelines to good manufacturing practice medicinal products for human and veterinary use, manufacture of biological active substances and medicinal products for human use, vol. And with the introduction of a significant revision to annex 1. In fact, it could be argued that in todays ever more digitally connected world, understanding the core of the eus guidelines, annex 11, and its approximate fda counterpart, 21 cfr part 11, the socalled elevens is more critical than ever. Chapter 5 production european commission health and consumers directorategeneral health systems and products medicinal products quality, safety and efficacy brussels, august 2014 eudralex the rules governing medicinal products in the european union volume 4 eu guidelines for good manufacturing practice for. Eu regulatory changes annex 1 is just one of a range of changes to eu gmp others include. Process validation annex 15 to ec gmp guide, glossary. Volume 4 of the rules governing medicinal products in the european union contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and. Annex 11 is focused on the life cycle of computerized systems. Annex 15 of the eu gmp guide is concerned with the qualification and.
The ec has announced a new revision of eu gmp annex 11 computerised systems. Manufacture of sterile medicinal products license holders and pharma suppliers should ask themselves. Comparison of 21 cfr part 11 and annex 11 of eu guidelines. Eudralex volume 4 good manufacturing practice gmp guidelines. These guidelines develop the gmp requirements that should be applied in the. New eu gmp for atmps vs existing gmps pros and cons. More than 10 years have passed since the last revision of the annex 1 of the eu gmp guideline for the manufacture of sterile medicinal products. Mra between eu and us annex to the euus mutual recognition agreement mra which was signed in 1998 but not yet implemented. The pics committee has adopted by written procedure the revision of annex 15 of the pics gmp guide which will enter into force on 1 october 2015, simultaneously to the eu revision of annex 15. Practice for medicinal products, qualification and validation, annex 15.
Eudralex volume 4 good manufacturing practice gmp guidelines, annex 15. On the 30th of march, the eu released its updated version of annex 15 qualification and validation which will be effective on 01 october 2015. Both guides are equivalent in terms of gmp requirements. Volume 4 good manufacturing practices annex manufacture of investigational medicinal. European commission enterprise and industry directorategeneral consumer goods pharmaceuticals brussels, 25 november 2008 rev. Efpia has previously communicated to the commission, the changes made to this text compared with the current eu gmp annex will have significant. Annex 16, volume 3, co2 certification requirement on 201703 06. An agency of the european union gmp, quality by design and validation mats welin, member of bwp and ema pat team presented by mats welin on 16 april 2015. Compared with the currently valid version the changes were significant in some parts see also the gmp news from 21. Eu gmps with annex 11, 15, 16, 18, 19 gmp publications. Eu gmp annex 1 update 2008 airborne particle counting.
Eudralex volume 4 good manufacturing practice gmp guidelines volume 4 of the rules governing medicinal products in the european union contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in commission directives 956eec. Quality system, chapter 7 of the gmp guide has been revised in order to provide. Eu gmp change impact on cleaning and process validation. Other guidelines published by the european commission should be taken into account where relevant. Part iv of eudralex volume 4 these guidelines are specific to atmps.
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