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+++ EudraLex Annex 11 - German Version +++ EMA news: Harmonised requirements for batch certification +++ Annex 11 - “Computerised Systems” - Revision 2011 - Implementation +++ CRO Computer System Validation: FDA Requirements +++ ISPE published the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) +++ Guidance for Industry - Process Validation: General Principles and Practices +++ EudraLex - Volume 4 (GMP): New Annex 11 (revision January 2011) +++ New EudraLex Vol. 4 - Annex 11 - Computerised Systems +++ PIC/S EXPLANATORY NOTES FOR SITE MASTER FILE +++ New GHTF document - CAPA +++ New Audit Services provided to industry +++ FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs +++ Medical Devices QMS: ISO 13485 and FDA requirements +++ Chinese ISPE GAMP 5 Version +++ Germany's BfArM moves to nearly paperless submissions (eCTD) +++ New GAMP publication: GAMP Good Practice Guide: MES +++ New GAMP publication: GAMP Good Practice Guide: A Risk-Based Approach to Operation +++ Computer Validation - FDA expectations and requirements +++ ICH Q10 - Quality Systems guideline +++ New: ISPE Good Practice Guide: Maintenance +++ ICH Q8/Q9/Q10 - Questions & Answers +++ ISPE Pharmaceutical Engineering Publication - March April 2009 +++ ISPE Good Practice Guide: Good Engineering Practice published +++ ICH: Contact the Quality IWG with your comment and questions concerning Q8-Q9-Q10 +++ PIC/S: REVISION OF PIC/S GMP GUIDE +++ EMEA: Eudralex Version 19 December 2008 +++ 21 CFR Part 11: current status (2008) +++ GAMP 5 and PRODUCT QUALITY LIFECYCLE IMPLEMENTATION (PQLI) +++ FDA Warning Letters 2008 (computer system validation) +++ ICH Q10: PHARMACEUTICAL QUALITY SYSTEM - Step 4 +++

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EudraLex Annex 11 - German Version

Saturday, 03 September 2011 16:43

ZLG published a German translation of Annex 11 - Revision 2011.

Open ZLG Announcement

Open A nnex 11 - German (deutsche Übersetzung Anhang 11 zum EU-Leitfaden der Guten Herstellungspraxis Computergestützte Systeme)

German Books for computer system validation - open link.

EMA news: Harmonised requirements for batch certification

Wednesday, 31 August 2011 06:36

The batch certificate will attest that the batch meets the specifications and has been manufactured in accordance with the marketing authorisation of the importing country, detailing the specifications of the product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing, packaging and quality control records were reviewed and found in conformity with GMP. The batch certificate will be signed by the person responsible for certifying that the batch is suitable for release for sale or supply/export.

For Electronic Batch Recording (Computer System Validation) the format should be implemented according the EMA requirements (OPEN) and EudraLex Annex 11.

Annex 11 - “Computerised Systems” - Revision 2011 - Implementation

Saturday, 11 June 2011 07:05

Article published on Pharmaceutical Technology Europe - New Annex 11: Enabling Innovation -

Read it online here.

ISPE published the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)

Friday, 11 February 2011 11:27

ISPE published the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition):

Table of contents

EudraLex - Volume 4 (GMP): New Annex 11 (revision January 2011)

Friday, 14 January 2011 00:40

EMA published today the new GMP Annex 11 - Computerised Systems - revision January 2011 - download your copy here: PDF

Find here also the new EudraLex Chapter 4 - Documentation: PDF

The deadline for coming into operation of the new Annex 11 and Chapter 4 "Documentation" is 30th June 2011.

Basic Principle of the new Annex 11:

This annex applies to all forms of computerised systems used as part of a GMP regulated

activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.

The application should be validated; IT infrastructure should be qualified.

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.

Read more (publication in German)

ZLG EFG Votum V11003 - electronic signatures - open

APV-Mainz Interpretation - Version 2.0 from 1st December 2010 - open