The following guideline can be ordered through the address listed in the sourcepublishercategory. Computerized systems as part of gmp regulated activities. Annex 11 provides guidance to help ensure electronic record integrity, which in turn helps ensure product safety. Eu annex 11 guide to computer validation compliance for. Electronic signatures scope and application division of drug information, hfd240 center for drug evaluation and research cder. Pharmaceutical inspection coop pic created a document defining. New revised eu gmp annex 11 ispe international society.
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. The eu first adopted the ich gmp guide on apis as annex 18 to the eu gmp guide while. In addition to industryleading document control features, deviations, customer feedback, training, and audit processes and more are all managed via an easy and familiar windows user interface and helps you to achieve compliance with regulations and industry standards such as fda 21 cfr part 11, eu gmp annex 11, iso 9001. Board obligations with regards to governmental advisory committee advice stress test 18 30 november 2015 5 15 several stakeholders supported an amendment to this proposal to remove the words any advice approved by the governmental advisory committee by consensus with objections only.
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 eu published annex 11 in 1992 as one of several guidance documents that supplements the 27member states gmp rules. Annex 11 is part of the european gmp guidelines and defines the terms of. Guidance for industry food and drug administration. Dear colleagues today i will try to focus on fda 21 cfr part 11 in detail by giving you indispensable explanations to each article. Moreover, annex 11 included guidelines for the use of computerized systems. Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these systems. Before anything else, could you please take a look at this update. Annex 11 provides guidance for the use of electronic documents. As noted above, part 11 and annex 11 are not completely aligned for example, the following annex 11 requirements do not have a corresponding crossreference to a part 11 requirement one reason for this is that part 11 is an addon regulation and some of these requirements are in the predicate regulations.
Product specification file 103 manufacturing formulae and processing instructions 103 packaging instructions 103. New revised eu gmp annex 11 ispe international society for. Annex 11 computerised systems 87 principle 87 general 87 risk management 87. 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. Guide to good manufacturing practice for medicinal. Further questions and answers are published as the need arises. A new draft of the european union eu guidelines to good manufacturing practice gmp annex 1, for sterile medicinal products manufacture, has been issued for public comment. Facility, equipment and process design must be optimized qualified and validated according to annex 11. Supplementary guidelines to the ecgmp guide with specific requirements for.
White paper for 21 cfr part 11 and eu annex 11 full compliance contents 1. Sparta systems trackwise digital solution 21 cfr part 11annex 11 assessment highlevel comparison of eu annex 11 and fda 21 cfr part 11 part 11 annex 11 scopeprinciple electronic records and electronic signatures as used for all fda regulated activities. Euannex11pdf european union european commission scribd. Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice manufacture of sterile medicinal products author european medicines agency. Eudralex the rules governing medicinal products in the. Gmp publications, basic eu gmps with annex 11, 15, 16, 18, 19.
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. 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. Pharma industry perspective on eu gmp annex 1 consultation document. Eus annex 11 and fdas 21 cfr part 11 mastercontrol. Eu gmp annex 11 for computerised systems has been an unchanged part of eu gmp since 1992. There are also associated changes to eu gmp chapter 4 documentation. These reports can include all data and audit trails. 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. Us fda cfr part 11 compliance eu annex 11 compliance. Interpreting 21 cfr part 11, revised eu annex 11 and data. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice gmp for medicinal.
Annex 1 calls for a contamination control strategy. Line numbers of the relevant text comment and rationale. Support for 21 cfr part 11 and annex 11 compliance. Since data security and integrity may have an impact on product quality and. 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. Bio represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations in more than 31 other nations. In 2008, the european medicines agency issued a proposed update that also consisted of a principle and 19 clauses but the length of text was four times as long as the current version. Are there uptodate detailed job descriptions for personnel who carry out gmp tasks. Article 5 of regulation ec no 9420072 mandates the commission to draw up guidelines on good manufacturing practice specific to advanced therapy medicinal products atmps. Annex 11 collaborative procedure in the assessment and. Eliminate unnecessary paper use electronic signatures replace the need to print and sign countless documents. Support for title 21 cfr part 11 and annex 11 compliance. Assuring e data integrity and part 11 compliance for empower. Comparison of fdas part 11 and the eus annex 11 eduquest.
Use ceruleans free selfassessment to help you begin to identify gaps in your part 11 andor annex 11 compliance program. In cases in which you can order through the internet we have established a hyperlink. A computerised system is a set of software and hardware components which together fulfill certain functionalities. Individual questions and answers may be removed when the. Eudralex volume 4 gmp, gmp annex 1, revision of november 25th, 2008 for noneea countries. While annex 11 is not a regulation, it is key to compliance with gmp. 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. Article 631 of regulation eu no 53620143 also empowers the commission to adopt and publish detailed guidelines on good manufacturing practice. Cerulean provides a formal, twoday diagnostic service for executives, business owners and due diligence teams.
Persons in responsible positions should have the appropriate training for the management and use of systems within their field of responsibility which utilises computers. Concept paper on the revision of annex 1 of the guidelines. Annex 11 as part of the eu gmp guide should focus on product quality and patient safety. Mfiles fulfills the technical requirements for fda 21 cfr part 11 and eu gmp annex 11. 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. 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. Chapter 1 pharmaceutical quality system 31 january 20 chapter 2 personnel 16 february 2014. Comparison of 21 cfr part 11 and annex 11 of eu guidelines. Eudralex volume 4 good manufacturing practice gmp guidelines. It is essential that there is the closest cooperation between key personnel and those involved with computer systems. How the vaisala continuous monitoring system aids compliance with title 21 cfr part 11 and eu gmp annex 11 white paper introduction two crucial regulatory guidelines that describe the proper use of computerised systems to perform gmprelated activities are the food and drug administrations. Annex 11 is part of the european gmp guidelines and defines the terms. Eu gmps with annex 11, 15, 16, 18, 19 gmp publications. The ec has announced a new revision of eu gmp annex 11 computerised.
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