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.

CRO Computer System Validation: FDA Requirements

Tuesday, 29 March 2011 19:06

 MORE INFORMATION:

Guidance for Industry Computerized Systems Used in Clinical Investigations

Guidance for Industry Electronic Source Documentation in Clinical Investigations

Practical hint: PSI Guide

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):

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