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Book of Validation - Download current regulations and templates

We have re-designed our download area for registered members. Now you have an up-to-date "book of validation" - with current regulations, standards, and templates.

Visit: http://www.ccs-inspired.com/downloads

We also offer to you a company and industry specific online library, regular updating services and GxP trainings. If you want to get more details about our services, contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

EMA news: Harmonised requirements for batch certification

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

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)

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

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