Avoiding Errors With The Batch Release Process: Best Practice CGMPs

Despite most companies having effective batch release procedures, errors can occur leading into products being released which are unsuitable (for the different reasons where a recall can occur). Such issues may be picked up by the company, consumers, or medical staff (such as in the form of a customer complaint). For example, one common reason for recalls is where process for testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications or identity and strength of each active ingredient prior to release (as per 21 CFR 211.165(a)).

 

 

 

To avoid such issues, this article considers some best practices for the batch release process.

 

 

Sandle, T. (2022) Avoiding Errors With The Batch Release Process: Best Practice CGMPs, Journal of GxP Compliance, 26 (2). DOI:  https://www.ivtnetwork.com/article/avoiding-errors-batch-release-process-best-practice-cgmps

 

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)