Jun 07, 2018 but what is computer equipment annex 11 is about computerized systems and the validation of application and the qualification of it infrastructure. The eu gmp guide annex 1 on sterile manufacturing of 2008 in comparison to the drafts of 2017 and 2020. Eus annex 11 and fdas 21 cfr part 11 mastercontrol. The intended audience for this guideline is any regulated customer within the life sciences industry. Guidance for industry food and drug administration. Electronic signatures scope and application division of drug information, hfd240 center for drug evaluation and research cder. Eu gmp annex 11 electronic signatures for the first time, the pharmaceutical organisations following eu gmp have the authority to use electronic signatures on regulatory documents, reports and records. Section g product label click upload file to upload the label. Use ceruleans free selfassessment to help you begin to identify gaps in your part 11 andor annex 11 compliance program.
On january 3rd, 2011 the european commission has published a. Eu annex 11 guide to computer validation compliance for the. Ignoring eu annex 11 could be as detrimental as ignoring the directives. While annex 11 is not a regulation, it is key to compliance with gmp principles in eu directives regulations covering human and veterinary medicinal products. Product specification file a reference file containing, or referring to files containing, all the information necessary to.
Background at first glance eu gmp 5 is structured very differently from the united states gmp for pharmaceuticals. Eu annex 11 guide to computer validation compliance for the worldwide health agency gmp orlando lopez this book provides practical information to enable compliance with computer system validation requirements, while highlighting and integrating the annex 11 guidelines into the computer validation program. Good manufacturing practices annex manufacture of investigational medicinal products july 2003. Sparta systems trackwise digital solution 21 cfr part 11annex 11 assessment introduction the purpose of this document is to outline the roles and responsibilities for compliance with the fdas 21 cfr part 11 and the european unions annex 11 as they apply to sparta systems trackwise digital product. Gmp publications, basic eu gmps with annex 11, 15, 16, 18, 19.
Good manufacturing practice medicinal products for human and veterinary use annex investigational medicinal products document history revision to reinforce the principle of independence between production and quality control functions in cases where the number of personnel involved is small. We will explore this question as we analyze the new regulations. Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these systems. The eu published annex 11 in 1992 as one of several guidance documents that supplements the 27member states gmp rules. Pdf eu gmp annex 1 the new draft and implications for. Eu annex 11 guide to computer validation compliance for the worldwide health agency gmp supplies practical information to facilitate compliance with computer system gmp requirements, while highlighting and integrating the annex 11 guidelines into the computer compliance program.
Click choose file to search the file, then click upload. 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 manufacture of biological active substances and medicinal products for human use into operation since 26 june 2018. A computerised system is a set of software and hardware components which together fulfill certain functionalities. 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. The aggregate of these differences is represented visually with the pointtopoint comparison matrix shown below. Annex 11 provides guidance to help ensure electronic record integrity, which in turn helps ensure product safety. Such an alteration should only be implemented with the agreement of the person responsible for the part of the system concerned, and the. Supplementary guidelines to the ecgmp guide with specific requirements for. Good manufacturing practice for medicinal products for human and veterinary use part 1. European gmp is split into three parts plus 20 annexes. Documents may be extracted from the adobe sign portal as pdf files which are.
Annex 11 outline broad technical and procedural controls that can be used in creating and storing electronic data used in gmp mandated records. Good manufacturing practice medicinal products for human and veterinary use annex 1 manufacture of sterile medicinal products corrected version document history previous version dated 30 may 2003, in operation since september 2003 revision to align classification table of clean rooms, to include. Product specification file 103 manufacturing formulae and processing instructions 103 packaging instructions 103. Support for title 21 cfr part 11 and annex 11 compliance. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice gmp for medicinal. User requirements should be traceable throughout the lifecycle. Annex 2 who good manufacturing practices for pharmaceutical. Eu gmps with annex 11, 15, 16, 18, 19 gmp publications. 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.
Chapter 1 pharmaceutical quality system 31 january 20 chapter 2 personnel 16 february 2014. Alterations to a system or to a computer program should only be made in accordance with a defined procedure which should include provision for validating, checking, approving and implementing the change. Q7 good manufacturing practice guidance for active. In particular its annex 11, computerised systems is used when inspecting such systems. Annex 11 is part of the european gmp guidelines and defines the terms of reference for computerised systems used by organizations in the. Annex 11 is one of nineteen supplementary requirements of the eu gmp guide. But what is computer equipment annex 11 is about computerized systems and the validation of application and the qualification of it infrastructure.
Where relevant the appropriate system of good manufacturing practices gmp or the nationally appropriate legal basis for gmp, should be indicated. The eu first adopted the ich gmp guide on apis as annex 18 to the eu gmp guide while. We plan to help you get ready now for the pending change. Annex 14 who guidelines for drafting a site master. Us fda cfr part 11 compliance eu annex 11 compliance. The revisions to annex 11 from 2011 align the eu gmps with the quality guidelines q810 published by the international. Trs 986, annex 2 who good manufacturing practices for pharmaceutical. Where a computerised system replaces a manual operation, there. Manufacturing formulae and processing instructions 104. For australian and new zealand manufacturers pics version is due this year, aside from significant changes in part 1, there are also significant changes in annex 11, computers systems and annex 15, qualification and validation. The system will automatically replace the existing attachment when a new document is uploaded. How the vaisala continuous monitoring system aids compliance.
Interpreting 21 cfr part 11, revised eu annex 11 and data. Documentation description of documentation system i. Cerulean provides a formal, twoday diagnostic service for executives, business owners and due diligence teams. After all, the concept paper had been published on may, 2015 already ema2382992015. Annex 11 357 c a regulatory authority associated with an ich member through a legally binding, mutual recognition agreement, including australia, iceland, liechtenstein and norway as before 23 october 2015. Download excel and pdf files 1 excel and 1 pdf file, in total 230 pages. 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. 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.
Annex 11 requirements for electronic signatures comparison of annex 11 requirements for electronic. However, the regulations do not offer much concrete advice on how its principles should be translated into practice during the validation and operation of computerised systems. High level comparison of annex 11 and part 11 annex 11 part 11. In 2011, the eu updated annex 11 to include all computerized systems that are part of the gmprelated activities to reflect the increased use and complexity of.
Eu annex 11 guide to computer validation compliance for the worldwide health agency gmp. Here you can download pdf version of icao annex 11 air traffic services. General introduction to gmp, history, ich, pics, eu, fda. 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. Annex 10 stability testing of active pharmaceutical ingredients and finished pharmaceutical products introduction and background the guidance on stability testing of active pharmaceutical ingredients and finished pharmaceutical products was published as annex 2 in the world health organization who technical report series, no. New revised eu gmp annex 11 ispe international society. Interpreting 21 cfr part 11 and revised eu annex 11 training understand what the regulation 21 cfr part 11 is, identify key terminology used in the regulation, lifecycle of a document, links to validation, validation requirements for computer systems, training requirements, management of systems, signatures, controls, understand fda part 11 guidance for industry, describe the gamp approach. A biological preparation that improves immunity to a particular disease. The guide has now been adopted as part ii of the pics gmp guide see pe 009 part ii. New revised eu gmp annex 11 ispe international society for. The ich guidance q7 good manufacturing practice guidance for active pharmaceutical ingredients is intended to provide guidance regarding good manufacturing practice gmp for the manufacturing of.
Comparison of fdas part 11 and the eus annex 11 eduquest. This annex is specific to the eu gmp guide and has not been adopted by pics. A more detailed, sidebyside breakdown of the two regulatory documents can be found in the article, annex 11 and 21 cfr part 11. The ec has announced a new revision of eu gmp annex 11 computerised. Us fda cfr part 11 compliance eu annex 11 compliance more and more companies are switching over to paperless records and computerised systems as a way to better keep track of all the data that can be accumulated during the manufacture, testing and release of a product. The drug manufacturers guide to site master files 4 focus of recent update pe 0084 the annex shaping the format and structure of contents of the site master file was completely revised chapter f. The ideas presented in this book are based on the authors 25 years. Eu annex 11 guide to computer validation compliance for. Annex 11 computerised systems 87 principle 87 general 87 risk management 87. Eudralex volume 4 good manufacturing practice gmp guidelines. Guide to good manufacturing practice for medicinal. Computerized systems as part of gmp regulated activities. Print version of pe009, the pics guide to gmp for medicinal products pdf, 678 kb.
Electronic signatures 21 cfr part 11 and eudralex volume 4 annex 11 computerised systems annex 11. Eu annex 11 guide to computer validation compliance for the worldwide health agency gmp orlando lopez this book provides practical information to enable compliance with computer system validation requirements, while highlighting and integrating the annex 11. There are also associated changes to eu gmp chapter 4 documentation. Microsoft and its customers for meeting the regulatory requirements of fda 21 cfr part 11 electronic records. The annex defines eu requirements for computerised systems, and applies to all forms of computerised systems used as part of gmp regulated activities. Nov, 2019 a more detailed, sidebyside breakdown of the two regulatory documents can be found in the article, annex 11 and 21 cfr part 11.
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