NEW:  PIC/S Aide-Memoire PI 038-1 Inspector Aide-Memoire for QRM implementation.

Qualitiy Management systems and Quality Risk Management approaches are supported by IT applications and systems. Read now the requirements for QRM implementation and investigate system interfaces to quality processes.

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

• Open ZLG Announcement

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

German Books for computer system validation - open link.

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.

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):

• Read more

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.

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Read more (publication in German) 

ZLG EFG Votum V11003 - electronic signatures - open

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

 

 The new EudraLex Vol. 4  GMP - Annex 11 - "Computerised Systems" is expected to come out in Q1/2011.

Annex 11 will be part of the new EudraLex on CD Version 24 - in January / February 2011.

• Contact us for more information, email to: talk@comes-compliance.com

Please find the new PIC/S "EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE" - OPEN LINK.

Content for Computer System Validation - ref. to 4.2.3 GMP critical computerised systems
- Description of GMP critical computerised systems (excluding equipment specific Programmable Logic Controllers (PLCs).

February 2011 update: EU GMP attached to Chapter 4 Documentation.