New technologies mean that new regulations are required to clarify the gmps. 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. This was proceeded by several coming soon messages. 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. The revision has been successfully completed by the pics subcommittee on the harmonisation of gmdp, led by paul gustafson canada rorb. The guide has now been adopted as part ii of the pics gmp guide see pe 009 part ii. A lot of uncertain issues were discussed and clarified, including the anticipated aseptic approach to get the operator away from the product. 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. 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. Principle general principles as applied to the manufacture of medicinal products. Revised annex 17 has been aligned with the eu revision of annex 17 which will be published shortly by the european commission ec. They want annex 1 better aligned with other regulatory and compendial standards for cleanroom designations and water for injection. Fda and eu gmp annex 1 differences in cleanroom specifications.
The published text is aligned with the international standards of who and pic s. Chapter 1 pharmaceutical quality system 31 january 20 chapter 2 personnel 16 february 2014. On december 20, the longawaited draft of annex 1 was published manufacture of sterile medicinal products. 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.
The manufacture of sterile medicinal products covers a wide. General introduction to gmp, history, ich, pics, eu, fda. More than 10 years have passed since the last revision of annex 1 of the eu gmp. They also want the european commission to eliminate certain filter testing. Scope additional areas other than sterile medicinal products where the general principles of the annex can be applied.
Revision of annex 1 manufacture of sterile medicinal. 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. This focuses on significant modifications since the first consultation in early 2018 and aims to gather stakeholders feedback on certain manufacturing steps. In the eea, part iv 1 of directive 200183ec as revised in 2009 contains a definition of. The guideline published in 1971 had last been revised in parts in 2008. 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 annex 1 revision may make mutual recognition of gmp. At the beginning of this month, the issue was also discussed at the ispe annual conference in dublin. Ad hoc gmp inspections services group ec guide to good manufacturing practice revision to annex 1 title. On 20 december 2017, the european commission ec published its longawaited revision draft of annex 1. In january 2011, the eu issued a revision to annex 11, with. Draft eu gmp annex 1 released pharmaceutical microbiology. 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.
New annex 1 for good manufacturing practice released in eu. Manufacture of sterile medicinal products draft short title. Industry groups have raised some concerns regarding the european commissions proposed revisions to the eus good manufacturing practice guidelines. The main instrument for harmonisation has been the pics gmp guide. Discussion on prepared selected questions on key concerns and comments on annex 1 revision. Prweb march 28, 2018 the parenteral drug association pda today released its comments to the european medicine agencys revision of gmp annex 1. Concept paper on the revision of annex 1 of the guidelines. So, what exactly is annex 1 of the eu gmp, and what does it mean for pharmaceutical companies operating in the usa. Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice manufacture. Whats new in the draft of annex 1 of the eu gmp guidelines. This annex is specific to the eu gmp guide and has not been adopted by pics. Vetter well prepared for the revision of eu gmp annex 1. Mcdowall january 2011 saw the publication of the new revision of european union eu gmp annex 11 on computerized systems and chapter 4 on documentation.
On 20 december 2017, almost 3 years after its announcement, the eu published a draft of the new annex 1 document. Woodland grange, leamington spa following the revision of eu gmp annex 1 for. Pharma industry perspective on eu gmp annex 1 consultation document. Changes to 2019 eu gmp annex 1 using one instrument for complete compliance.
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. It should also be included in the gmp design strategy. 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. Pdf updates to eu gmp annex 1, including iso 14644 changes. Does my organization utilize production, facility or. Good manufacturing practice european medicines agency. The numerous changes to the european and american guidelines in recent years must be harmonised with the new annex 1. This is the first revision since annex 1s inception in 1996. 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. 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. There are also associated changes to eu gmp chapter 4 documentation. New guidance for sterile products manufacture is coming.
The impact on microbial id strategy on cleanroom qualifications for pharma manufacturers. Other us viewpoints on the annex 1 revision from experts in the area of aseptic. Update on changes in eu gmp guide summary of gmp changes to the guide important details of changes over the last year other eu gmp regulatory changes deficiencies where does this information come from references deficiencies associated with the quality system and annex 1 reminder of why deficiency data may be important. Since its creation, pics has been active in the development and promotion of harmonised gmp standards and guidance documents. 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. 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.
Comparison of 21 cfr part 11 and annex 11 of eu guidelines to gmp. Woodland grange, leamington spa following the revision of eu gmp annex 1 for sterile medicinal product manufacturing the phss. Eudralex volume 4 good manufacturing practice gmp guidelines. Updates to eu gmp annex 1, including iso 14644 changes. 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. Eu regulatory changes annex 1 is just one of a range of changes to eu gmp others include. Annex 2 is no longer applicable to advanced therapy medicinal products to which applies the commission guideline on good manufacturing practice for advanced therapy medicinal products, published in part iv of. Sabine paris from the editorial office of the gmpverlag was on site and brought these news with her. Industry groups raise concerns about proposed eu gmp annex. The revised annex 1 of the gmp guidelines is close to publication.
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. 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. The impact on microbial id strategy on cleanroom qualifications for.
Both guides are equivalent in terms of gmp requirements. Concept paper on the revision of annex 1 of the guidelines on. More than 10 years have passed since the last revision of the annex 1 of the eu gmp guideline for the. The revised gmp guide pe 00914 will enter into force on 1 july 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. Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these systems. A signal that the draft was imminent was sent in january 2015 via a concept paper. It can also be sent by post to 127 directorategeneral for health and food safety, unit sante b4, be1049 brussels. Review of eu gmp annex 1 by tim sandle jan 23, 2018 8. 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. Pdf refresh the requirement of all gmps will only consider sterile products no application of. Annex 1 1 manufacture of sterile medicinal products 2.
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. Quality risk management and the draft annex 1 revision. Finally, nearly 3 years after it was announced, the new annex 1 for good manufacturing practice gmp has been released in draft form. Concerns surrounding annex 1 proposed revisions european. Here, james tucker, ecolab life sciences, explores the potential impacts on cleaning and disinfection regimes within sterile manufacturing areas. 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. Pdf eu gmp annex 1 the new draft and implications for. 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. Medicines and healthcare products regulatory agency and pics committee representatives, over 6,200 comments were received during the comment period. Well prepared for the revision of the eu gmp annex 1. It is not meant to address all changes within the revision.
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. 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. Annex 2 who good manufacturing practices for pharmaceutical. Eu gmp annex 1 compliant environmental monitoring solutions and instruments. The ec has announced a new revision of eu gmp annex 11 computerised systems.
Quality risk management and the draft annex 1 revision what. Comparison of 21 cfr part 11 and annex 11 of eu guidelines. 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. The eu gmps were first published in 1989, reconstructed in october 2005 and updated in december 2010. The new draft of the annex is not the first revision. Eu gmp annex 1 whats new for sterile product manufacturing. Eu gmp annex 1 2020 volume 4 eu guidelines to good. New revised eu gmp annex 11 ispe international society. Pqs reinforce the existing requirements of eu gmp eu directive 200394 article 5 eu directive 200183 article 23 chapter 3 chapter 5 5.