Manufacture of sterile medicinal products draft for comments, december 2017. What steps are being taken by eu authorities to assure the consistent interpretation of the requirements of the revised annex by eu gmp. The new revision to the annex includes a number of revised requirements. Qualification and validation into operation since 1 october 2015. Eu gmp annex 1 manufacture of sterile medicinal products revision 2020 abstract expanding from 127 clauses in the 2008 revision to 300 clauses in the 2020 revision, will annex 1 be any less ambiguous. Eu gmp annex 1 manual were revised for the manufacture of largescale. On the 12 th of march 2018, there was a discussion conference in england chaired by andrew hopkins, mhra, gdmp expert and head of the eu gmp annex 1. Mar 26, 2016 eudralex volume 4 good manufacturing practice gmp guidelines. Operational manual inspection of tissue and cell procurement and tissue. Eu regulatory changes annex 1 is just one of a range of changes to eu gmp others include. It has been 10 years since the last revision of the annex 1 of the eu gmp and, in that time, many advances have been made that impact many areas of big pharma. New guidance for sterile products manufacture is coming. In addition to the guidance outlined in the main chapters and annexes, it was a thought that there was a need to publish a specific guideline on importation of medicinal products under a dedicated annex of the gmp guideline. Eugmp guideline of annex 21 importation of medicinal.
This presentation is compiled by drug regulations a non profit organization which provides free online resource to the pharmaceutical professional. Apr 07, 2020 on 20 th march 2020 the eu gmp guideline of annex 21 importation of medicinal products was published as a draft. An industry expert tells pharmaceutical manufacturers to be aware of changes proposed for annex 1 of the european commissions gmp guide that affect visual inspections and particulate control for new parenteral drugs. Therequirements laid down in this document have to be implemented by the industryby 1 march 2009. Detailed commission guideline of 8 december 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the article 63 1 of regulation eu no 5362014 applicable as from the date of entry into application of regulation eu no 5362014 on clinical trials annex 14.
Annex 1 last revision revision completed december 2007. Supplementary guidelines to the ec gmp guide with specific. The first draft without a version number was released for widespread public comment on 22 nd december 2017 1 designated to replace the current annex, which was last. Eu begins second consultation to revise annex 1 of eu gmp. The drafting group processed more than 6200 lines of comments.
A lot of operational aspects of sterile production are now much more detailed and cleared, and new challenges are arriving for sterile manufacturers to get compliance with gmp guidelines, not only related with equipment and cleanrooms but also with their quality personnel. The eu first adopted the ich gmp guide on apis as annex 18 to the eu gmp guide while pics adopted it as a standalone gmp guide pe 007. Eu gmp annex 1 and iso 14644 prepared by tim sandle 1. Pdf latest draft of eu gmp annex 1 signals changes for. I believe that annex 1 dates back to september 2003 and has been revised to align the cleanroom classification table and provide guidance on media simulations, bioburden monitoring and the capping of vials. Terminal sterilisation vs aseptic processing wfi produced by reverse osmosis guidance for media simulation trials this remains speculative changes to cleanroom classification iso 14644 this is factual, based on the newly published standard prepared by tim sandle 2. This training session will help you understand about expectations by eugmp for the computerised systems as per annex 11 and how we should evaluate the compli. On 20 th march 2020 the eu gmp guideline of annex 21 importation of medicinal products was published as a draft. Annex 1 becomes effective on march 1st, 2009, except for capping, in. Eu gmp annex 1 manufacture of sterile medicinal products revision 2020 main gmp guide. Jan 23, 2018 annex 1 of eu gmp was first issued in 1989 and it has undergone no major revision since 2007 and no change whatsoever since 2009 in 2009 there was a minor point of clarification about the required air supply grading for oversealing grade a air supply 2. General introduction to gmp, history, ich, pics, eu, fda.
Annex 1 manufacture of sterile medicinal products of the eu gmp guidelines is currently being revised. The purpose of this guide is to walk usbased clinical supply professionals through the labeling requirements laid out in annex of the eu gmp guidelines. Eu gmp annex 1 revision joint phss and pqg conference. Provisions on capping of vials in this annex will enter into force on 1 march.
Eu gmp annex 1 update 2008 airborne particle counting. Agenda what is likely to go into the revised annex 1, including. Where a computerised system replaces a manual operation, there should be no. Updates to eu gmp annex 1, including iso 14644 changes. This latest revision includes significant changes that aim to improve the current practices in the whole of sterile manufacturing and, it is hoped, will lead towards a new global standard. Ingrid walther, pharma consulting walther, chair eca annex 1 task force background. The formal cleanroom testing for classification should be done per the en iso 14644 1 standard. Chapter 3 premise and equipment 1 march 2015 chapter 4 documentation january 2011 chapter 5 production 1 march 2015. Annex 1 of eu gmp was first issued in 1989 and it has undergone no major revision since 2007 and no change whatsoever since 2009 in 2009 there was a minor point of clarification about the. The annex will shortly undergo a comprehensive update, as signalled by a new draft issued in february 2020. Proposed changes to eu gmp annex 1 sterile manufacture gmp annex 1 sterile manufacture. What are the key changes in the 2008 revision of annex 1 of the eu gmp. Eu gmp annex 1 guidance for the manufacturing of sterile medicinal products this standard applies to sterile medicinal products and active substances, and focuses on preventing contamination of products by particulates, microbes and endotoxins a fevercausing pyrogen. The annex will shortly undergo a comprehensive update, as signalled by a new draft.
New version of annex 1 to the ec gmp guide on sterile. Annex 1 is just one of a range of changes to eu gmp others include. The second draft of gmp annex 1 has been recently released and the issue date for the new revision is finally approaching. In conclusion, the new annex 1 is going to request manufacturers to adopt an overall risk assessment approach and build a robust and scientificallybased management system for the sterility assurance of their products. This annex is specific to the eu gmp guide and has not been adopted. Concerns surrounding annex 1 proposed revisions european. Chapter 1 pharmaceutical quality system 31 january 20 chapter 2 personnel 16 february 2014. May 21, 2019 the eu gmps were first published in 1989, reconstructed in october 2005 and updated in december 2010. Both guides are equivalent in terms of gmp requirements. Pdf eu gmp annex 1 the new draft and implications for sterile.
Eu gmp annex 1 european pharmacopoeia pic s other helpful documents en iso 14644 1, 2. In doing so the focus is on those aspects that are different to the 2017 draft, rather than spending much time comparing the 2020 draft with the current annex 1 which is dated 2009. Eu gmp annex 1 specifies the same grade a for both filling. Webinar hosted by dr tim sandle discussing the eu gmp annex 1 updates and implications for sterile products manufacture. 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, annex 1. Detailed commission gui deline on gmp for imps published 20122017. Martin melzer 3 staatliches gewerbeaufsichtsamt hannover agenda relevant and legally binding documents eu gmp annex 1 european pharmacopoeia. Since 1971, annex 1 of the eus good manufacturing practice gmp guide has helped with the manufacture of sterile medicinal products, but now the european commission, european medicines agency, pics and who are launching a second consultation on fully revising the annex and introducing the principles of quality risk management qrm. Annex 1 to the good manufacturing practices guide manufacture of sterile drugs gui0119 page 7 of 43 guidance 4. Annex 1 1 manufacture of sterile medicinal products 2 document. 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.
It supplements the eu clinical trials regulation ctr 5362014 by specifying principles and guidelines for good manufacturing practice gmp for investigational medicinal products imps for human use and arrangements for inspections. Eu gmp annex 1 manufacture of sterile medicinal products revision 2020 abstract expanding from 127 clauses in the 2008 revision to 300 clauses in the 2020 revision, will annex 1 be. Timeline for eu gmp annex 1 revision remains unclear. Clearly the latest consultation draft is more than a revision, it is a rewrite. Dec 11, 2015 presentation on eu gmp annex 16 certification by qp 1. Eudralex volume 4 good manufacturing practice gmp guidelines. If you choose our virtual learning option, training will be delivered via a combination of live instructorled virtual classrooms and selfpaced. Consultation on the annex 1 draft closes on 20th march 2018. The guide has now been adopted as part ii of the pics gmp guide see pe 009 part ii.
Following the release of the draft copy of eu gmp annex 1 for public consultation, phss jointly with pqg pharmaceutical quality group organised a conference for its members to question one of the authors of annex 1, and to openly discuss the annex 1 along with the response that phss and pqg will. Pdf eu gmp annex 1 the new draft and implications for. Contamination reduces effectiveness of sterilization and contaminants from the air can deposit on surfaces and reduce the effects of sterilization. These have now been taken into account in the preparation of a second draft. Tim the link was for the current guide 2008 corrected 2009. Guide to good manufacturing practice for medicinal products. Whats new in the draft of annex 1 of the eu gmp guidelines.
Presentation on eu gmp annex 16 certification by qp. Some guidance may also be used to support the manufacture of nonsterile. The use of appropriate current 32 technologies should be implemented to ensure protection and control of the product 33 from potential extraneous sources of particulate and microbial contamination such as 34 personnel, materials and the surrounding environment. Annex 1 of the eu gmp guide was then adopted by pics, which in turn has provided the guidance to pics member countries including australia. Eu gmp annex 1 manufacture of sterile medicinal products. Revision of annex 1 of the eu gmp guide hv manufacture of sterile medicinal products. The revision calls for stricter standards for visually screening products for defects. Timeline for eu gmp annex 1 revision remains unclear pink. The global acceptance and implementation of ich q9 quality risk management and q10 pharmaceutical quality system, is not reflected in the current annex. Good manufacturing practices guide manufacture of sterile drugs gui0119 page 10 of 43 102. Impact on environmental monitoring programs 1 800 238 1801 page 1 of 8 itout measurement tere is no control introduction on december 20th, after intensive research and debates, the draft for a revision of annex 1 manufacture.
This webinar is part of a complimeny series provided by rssl. Part ii covers gmp for active substances used as starting materials. Terminal sterilisation vs aseptic processing wfi produced by reverse osmosis guidance for media simulation trials this remains speculative changes to cleanroom classification iso 14644 this is factual, based on the newly. This standard applies to sterile medicinal products and active substances, and focuses on preventing contamination of products by particulates, microbes and endotoxins a fevercausing pyrogen. A first targeted consultation to the annex 1 of the eu gmp guide allowed about 140 companies and organizations to comment. On the 12 th of march 2018, there was a discussion conference in england chaired by andrew hopkins, mhra, gdmp expert and head of the eu gmp annex 1 emapicswho revision working group.
Eu gmp annex 1 guidance for the manufacturing of sterile medicinal products. Pdf eu gmp annex 1 is the primary document governing the. With the provisions on capping of freeze dried vials implemented by march 1st, 2010 cleanroom and clean air device classification. Differences between gmp part i and part ii and ich q7 swissmedic. Proposed changes to eu gmp annex 1 sterile manufacture. Manufacture of sterile medicinal products revision november 2008.
Mar 04, 2020 directorpharmqa compliance services gmpglpgcppharmaceuticalconsultant and trainer on 20 february, the directorate for health and food safety of the european commission published a second draft. This update comes into operation on march 1st, 2009. For new or amended text for the eu gmp or gdp guide i. This 159 second video is part 2 of a 2 part series on eu gmp for cleanrooms and controlled environments. Were you perhaps referring to the new annex 2 for biological active substances. The commission delegated regulation eu 20171569 was issued on 23 may 2017. The use of appropriate current 32 technologies should be implemented to ensure protection and control of the product 33 from potential extraneous sources of particulate and microbial contamination such. Pharmaceutical quality system pqs compared with gmp part 1 old chapter 2 section 3 key personnel includes the head of production, the head of quality control, and if at least one of these persons is not responsible for the release of products the authorisedpersons designated for the purpose. This annex is specific to the eu gmp guide and has not been adopted by pics. Opinions of a pharmaceutical microbiologist on proposed revisions to the eu gmp annex 1 re current industry practice and future innovation. The document, a milestone standard for all sterile manufacturers, has been widely revised and extended, with important insights and implementations for the sterility assurance of the finished products. Concept paper on the revision of annex 1 of the guidelines on. The document was published on 8th march 2019 and becomes effective from 1st october 2019. An introduction to eu gmp european union good manufacturing.
Apr 30, 2020 annex 1, revised draft a brief summary available as recorded version on thursday, 30 april 2020. March 1st, 2009, except for capping, in order to give enough time to industry to set on the new requirements. Cleanrooms and associated controlled environmentspart 1. Eu gmp guideline annex 1 we know the gmp requirements. Sterile drug products produced by aseptic processing current good manufacturing practice. It should also be included in the gmp design strategy. New annex 21 of the eu gmp guide hv guidance for importers of medicinal products. This annex details guidance for investigational medicinal products. This update comes into effect on march 1, 2009 for all our environmental sensors.
Eu gmp annex 1 and iso 14644 prepared by tim sandle 1 2. Eu good manufacturing practice annex investigational. Join us on this course to gain insight into the cgmp expectations of eu gmp volume 4 annex 1, including how to generate an endtoend contamination control strategy that balances precautions to risk. Eu begins second consultation to revise annex 1 of eu gmp guide on sterile drug manufacturing. The purpose annex 1 of eu gmp has undergone no major revision of these guidances, is to detail the controls required since 2007 and no change whatsoever since 2009 around the manufacture of sterile products.
580 967 1477 769 668 480 716 1320 1246 1586 1341 181 945 1106 1444 369 1084 201 1309 1578 564 799 829 960 1204 148 1338 674 445