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.