This change to annex 15 takes into account changes to other sections of the eu gmp guide part i, annex 11, ich q8, q9, q10 and q11, qwp guidance on process validation and changes in manufacturing technology. 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. Working party on control of medicines and inspections final. Seamless integration of astm e2500, annex 15, fda process. There are also associated changes to eu gmp chapter 4 documentation. Good manufacturing practices annex manufacture of investigational medicinal products july 2003.
The ec has announced a new revision of eu gmp annex 11 computerised systems. How do new developments find their way into the eu gmp guide. The description of computerised systems required by eu. Annex 1 of eu gmp has undergone no major revision since 2007 and has seen no change whatsoever to its contents since 2009. Annex 2 is no longer applicable to advanced therapy medicinal products to which applies the commission guideline on good manufacturing practice for advanced therapy medicinal products,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. Expectations with adoption of the pics gmp guide pe009. Validation is a lifecycle with pharmaceutical development as basis and also a stage 3 is mentioned, called ongoing process verification. Eu regulatory changes annex 1 is just one of a range of changes to eu gmp others include. Annex 15 of the eu gmp guide is concerned with the qualification and. This annex is specific to the eu gmp guide and has not been adopted by pics. The guide has now been adopted as part ii of the pics gmp guide see pe 009 part ii.
Gmp publications, basic eu gmps with annex 11, 15, 16, 18, 19. A signal that the draft was imminent was sent in january 2015 via a concept paper. Draft annex 15 v12 200115 for pics and ec adoption. Airborne particle counting for pharmaceutical facilities. Responsibility of qp to ensure eu gmp standards details dependent on country of origin, availability of eu market authorisation etc. 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. Pt chapter 5 production european commission health and consumers directorategeneral public health and risk assessment medicinal products quality, safety and efficacy brussels, eudralex the rules governing medicinal products in the european union volume 4 eu guidelines for good manufacturing practice for. This annex is specific to the eu gmp guide and has not been adopted by. May be used as supplementary optional guidance for active substances without introduction of additional requirements to eudralex, volume 4, part ii.
Eu gmp annex 1 and iso 14644 prepared by tim sandle 1 2. Regulation or standard site master file quality manual eu gmp yes chapter 4 yes chapter 1 pics gmp version 11 2017 yes chapter 4 yes chapter 1 who gdrp 2016 no yes eu and pics smf guidance document yes no specific requirement iso 9001 2015 no yes 20, no 2015 now more general ich q10 no yes adapted from tang, s. With the revision of annex 15 eu gmp guide the eu is going in the same direction. General introduction to gmp, history, ich, pics, eu, fda.
Gmp that manufacturers identify what validation work is needed to prove. 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. 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. Agenda what is likely to go into the revised annex 1, including. Comparison of eu gmp guidelines with who guidelines. Validation is a lifecycle with pharmaceutical development as basis and also. Eu gmps with annex 11, 15, 16, 18, 19 gmp publications. 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. This annex deals with the collection and storage of reference samples of starting materials, packaging materials and retention samples of finished products. Regulations have binding legal force in every member state ms. Qualification and validation legal basis for publishing the detailed guidelines. Where manual cleaning of equipment is performed, it is especially important that. Validation and qualification form an important part of the quality system in the pharmaceutical sector and can be defined in different ways.
In february 2014 the draft for the revision of eu gmp annex 15 was published see the gmpnews from 11 february 2014 revision of the eu gmp annex 15 for qualification and validation published. January 2011 saw the publication of the new revision of european union eu gmp annex 11 on computerized systems and chapter 4 on documentation. Eus annex 11 and fdas 21 cfr part 11 mastercontrol. As one difference the annex 15 asks to also list noncritical attributes and parameters in the validation protocol. The pics revised annex 15 can be downloaded from the link below. Efpia comments on da on gmp for imp final 24nov2015. New eu gmp annex 15 revision published valid as of 1 october 2015 02042015. Compared with the currently valid version the changes were significant in some parts see also the gmpnews from 21.
Product specification file a reference file containing, or referring to files containing, all the information necessary to. Template for the written confirmation for active substances exported to the european union for medicinal products for human use version 2, january 20 guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared. Eu guidelines for good manufacturing practice for medicinal products for human and veterinary use annex 15. Since annex 15 was published in 2001 the manufacturing and. Update as per concept paper on revision of annex 15. In february 2014, a draft of the revised annex 15 was released by the european commission ec for public comment. 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. Process validation in the light of the revised annex. In europe 3 validation approaches are now possible traditional, continuous and hybrid. A better match with the fda guideline was also one of the reasons for the revision of eugmp guide annex 15. On december 20th 2017 the european commission produced a draft of annex 1. Formal validation and qualification are both requirements of gmp.
Process validation in the light of the revised annex 15. Chapter 1 of the eu gmp guidelines presents an overview of the chapters to come. On october 1st, 2015, changes to the eu guidelines on gmp annex 15 went into effect. New revised eu gmp annex 11 ispe international society. The draft version is based on an ema concept paper, published in november 2012 which outlined various reasons for. Breakdown by eu guidelines to gmp chapter or annex the data provides a breakdown of the number of deficiencies according to the chapters that comprise the eu guidelines to gmp. Eudralex volume 4 good manufacturing practice gmp guidelines. We do not see the need to introduce a requirement for a product specification file into the delegated act.
Trs 986, annex 2 who good manufacturing practices for pharmaceutical. The following guideline can be ordered through the address listed in the sourcepublishercategory. What is the present status of the revision of the eu gmp guide. Chapter 1 pharmaceutical quality system 31 january 20 chapter 2 personnel 16 february 2014. I should like to begin by saying that i love to be a european citizen and that i like the european union eu, its ideas, visions and many results over the last centuries. In cases in which you can order through the internet we have established a hyperlink. Pdf eu gmp annex 1 the new draft and implications for. Updated version of annex 15 qualification and validation. Outline supported operating system microsoft office excel 2010, excel 2007 note. Article 47 of directive 200183ec on the community code relating to medicinal products for. Annex 14 who guidelines for drafting a site master.