Whats new in the draft of annex 1 of the eu gmp guidelines. Industry groups have raised some concerns regarding the european commissions proposed revisions to the eus good manufacturing practice guidelines. Draft eu gmp annex 1 released pharmaceutical microbiology. Quality risk management and the draft annex 1 revision. The manufacture of sterile medicinal products covers a wide. New technologies mean that new regulations are required to clarify the gmps.
On 20 december, the european commission published the longawaited revision draft of annex 1 manufacture of sterile medicinal products of the eu guideline for good manufacturing practice for drug products and drug substances. More than 10 years have passed since the last revision of annex 1 of the eu gmp. The ec has announced a new revision of eu gmp annex 11 computerised systems. Woodland grange, leamington spa following the revision of eu gmp annex 1 for sterile medicinal product manufacturing the phss. New annex 1 for good manufacturing practice released in eu. Manufacture of sterile medicinal products draft short title. The impact on microbial id strategy on cleanroom qualifications for.
The annex 1 of the eu gmp guide manufacture of sterile medicinal products is considered the most important european regulatory standard for the manufacture of sterile pharmaceutical products. This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the eu good manufacturing practice annex 1 in terms of current industry practice and future innovation in sterile product manufacturing. Medicines and healthcare products regulatory agency and pics committee representatives, over 6,200 comments were received during the comment period. It should also be included in the gmp design strategy. The impact on microbial id strategy on cleanroom qualifications for pharma manufacturers. Why annex 1 is important to you key reasons for revision to annex 1 what should i be asking myself, regardless of the dosage form i am responsible for. Concerns surrounding annex 1 proposed revisions european. 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. Chapter 1 pharmaceutical quality system 31 january 20 chapter 2 personnel 16 february 2014. A lot of uncertain issues were discussed and clarified, including the anticipated aseptic approach to get the operator away from the product. The association credited ema for the tremendous effort it put forth revising the annex to integrate new concepts and to facilitate the introduction. Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these systems.
Draft annex 2a takes into account the international development in the regulation of advanced therapy medicinal products atmp with particular attention to the european commission guideline on gmp for atmp which has been published since the latest revision of the eu annex 2, while addressing at the same time concerns of pics participating. More than 10 years have passed since the last revision of the annex 1 of the eu gmp guideline for the. Review of eu gmp annex 1 by tim sandle jan 23, 2018 8. Woodland grange, leamington spa following the revision of eu gmp annex 1 for. Comparison of 21 cfr part 11 and annex 11 of eu guidelines to gmp. Manufacture of sterile medicinal products 1st draft adopted by ad hoc gmp inspectors group october 2002 released for public consultation november 2002 january 2003 final draft adopted by ad hoc gmp inspectors group april 2003. Sabine paris from the editorial office of the gmpverlag was on site and brought these news with her. The revised gmp guide pe 00914 will enter into force on 1 july 2018. Revision of annex 1 manufacture of sterile medicinal. It has been and continues to be speculated when the final version of annex 1 on the sterile manufacture of medicinal products will finally be published. On 20 december 2017, almost 3 years after its announcement, the eu published a draft of the new annex 1 document.
Well prepared for the revision of the eu gmp annex 1. New manufacture of biological active substances and medicinal products for human use into operation since 26 june 2018. Draft eu gmp annex 1 released the pics secretariat has notified that the revised eupics gmp annex 1 on the manufacture of sterile medicinal products has reached step 2 of the revision process and on 20 december 2017, the pics and ema published the draft revision of annex 1 for public consultation. General introduction to gmp, history, ich, pics, eu, fda. The main instrument for harmonisation has been the pics gmp guide. In the eea, part iv 1 of directive 200183ec as revised in 2009 contains a definition of. It can also be sent by post to 127 directorategeneral for health and food safety, unit sante b4, be1049 brussels. So, what exactly is annex 1 of the eu gmp, and what does it mean for pharmaceutical companies operating in the usa.
The 2018 and presumably 2019 update contains substantial additional detail on virtually every topic in the 2007 version. New guidance for sterile products manufacture is coming. Manufacture of sterile medicinal products 1st draft adopted by ad hoc gmp inspectors group october 2002 released for public consultation november 2002 january 2003 final draft adopted by ad hoc gmp inspectors. The published text is aligned with the international standards of who and pic s.
Comparison of 21 cfr part 11 and annex 11 of eu guidelines. Vetter well prepared for the revision of eu gmp annex 1. Principle general principles as applied to the manufacture of medicinal products. This was proceeded by several coming soon messages. Since its creation, pics has been active in the development and promotion of harmonised gmp standards and guidance documents. Pdf updates to eu gmp annex 1, including iso 14644 changes. The eu and pics annex 1 has long been the gmp bible for manufacturers of sterile medicines, but with more than 10 years now passed since its previous revision, it is fair to say an update is long overdue. The latest revision will be released in 2019, and is expected to have a greater reaching impact on qaqc and all laboratory activities in the eu and abroad. The revision, an overhaul of the 2008 version of annex 1, went out for public comments in january 2018, with comments due for submission by march 20, 2018. The european commission is holding a second targeted stakeholder consultation on the updated draft annex 1 of the eu gmp guidelines on manufacturing of sterile medicinal products. Manufacturing of sterile medicinal products is now under revision. Eu gmp guide new annex 1 fda aseptic guide pics guide recommendations on the validation of aseptic processes main changes compared to still valid annex 1 implementation of new requirements into routine annex 1 changes, challenges and consequences 2829 november 2018, berlin, germany.
On 20 december 2017, the european commission ec published its longawaited revision draft of annex 1. Eu gmp annex 1 2020 volume 4 eu guidelines to good. 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. They also want the european commission to eliminate certain filter testing. Quality risk management and the draft annex 1 revision what. The pics secretariat has notified that the revised eu pics gmp annex 1 on the manufacture of sterile medicinal products has reached step 2 of the revision process and on 20 december 2017, the pics and ema published the draft revision of annex 1 for public consultation. Fda and eu gmp annex 1 differences in cleanroom specifications. New revised eu gmp annex 11 ispe international society.
Concept paper on the revision of annex 1 of the guidelines on. Here, james tucker, ecolab life sciences, explores the potential impacts on cleaning and disinfection regimes within sterile manufacturing areas. They want annex 1 better aligned with other regulatory and compendial standards for cleanroom designations and water for injection. Changes to 2019 eu gmp annex 1 using one instrument for complete compliance.
Nov 21, 2018 the revision, an overhaul of the 2008 version of annex 1, went out for public comments in january 2018, with comments due for submission by march 20, 2018. There are also associated changes to eu gmp chapter 4 documentation. Ad hoc gmp inspections services group ec guide to good manufacturing practice revision to annex 1 title. Updates to eu gmp annex 1, including iso 14644 changes. This is the first revision since annex 1s inception in 1996.
Other us viewpoints on the annex 1 revision from experts in the area of aseptic. This annex is specific to the eu gmp guide and has not been adopted by pics. Does my organization utilize production, facility or. Eu gmp annex 1 compliant environmental monitoring solutions and instruments.
Both guides are equivalent in terms of gmp requirements. Industry groups raise concerns about proposed eu gmp annex. The 128 subject line of the letter or email should contain the reference targeted public consultation 129 revision of annex 1 of eu gmp guide. 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. Good manufacturing practice european medicines agency. The revision has been successfully completed by the pics subcommittee on the harmonisation of gmdp, led by paul gustafson canada rorb.
The special feature here is that the revised annex 1 will not be an independent eu document but should also apply directly to the pics guidelines. In january 2011, the eu issued a revision to annex 11, with. Scope additional areas other than sterile medicinal products where the general principles of the annex can be applied. The eu gmps were first published in 1989, reconstructed in october 2005 and updated in december 2010. Eu gmp annex 1 whats new for sterile product manufacturing. 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. Eudralex volume 4 good manufacturing practice gmp guidelines. This focuses on significant modifications since the first consultation in early 2018 and aims to gather stakeholders feedback on certain manufacturing steps. Eu regulatory changes annex 1 is just one of a range of changes to eu gmp others include. Annex 11 is focused on the life cycle of computerized systems. Pharma industry perspective on eu gmp annex 1 consultation document. Pdf refresh the requirement of all gmps will only consider sterile products no application of. Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice manufacture.
The revised annex 1 of the gmp guidelines is close to publication. The guideline published in 1971 had last been revised in parts in 2008. The annex 1 revision may make mutual recognition of gmp. Prweb march 28, 2018 the parenteral drug association pda today released its comments to the european medicine agencys revision of gmp annex 1. Annex 11 has been revised in response to the increased use of computerised systems and. Annex 2 who good manufacturing practices for pharmaceutical.
At the beginning of this month, the issue was also discussed at the ispe annual conference in dublin. 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. Concept paper on the revision of annex 1 of the guidelines. On december 20, the longawaited draft of annex 1 was published manufacture of sterile medicinal products. Annex 1 to the european union good manufacturing practice gmp guidelines is now under formal revision, with a concept paper issued during february 2015 and with a. Annex 1 1 manufacture of sterile medicinal products 2. Revised annex 17 has been aligned with the eu revision of annex 17 which will be published shortly by the european commission ec. It is not meant to address all changes within the revision. Finally, nearly 3 years after it was announced, the new annex 1 for good manufacturing practice gmp has been released in draft form. Annex 1 to the european union good manufacturing practice gmp guidelines is now under formal revision, with a concept paper issued during february 2015 and with a view to implement the new. Pqs reinforce the existing requirements of eu gmp eu directive 200394 article 5 eu directive 200183 article 23 chapter 3 chapter 5 5. The guide has now been adopted as part ii of the pics gmp guide see pe 009 part ii.
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