Thursday 1 April 2021

Complying With Batch Release: Auditing Electronic Batch Records


To ensure that quality is maintained throughout the pharmaceutical or healthcare organization, frequent audits, both internal and external, are required to assess the quality and effectiveness of the processes, systems, and personnel employed by the company. Audits are an important part of quality assurance and the quality management system. This concept needs to apply to computerized systems as much as physical operations. Within pharmaceuticals, perhaps the most important computerized system is the electronic batch record.

This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation. It is only through conducting rigorous audits that the pharmaceutical organization can stay ahead of the regulatory expectations.

The article has been published on Pharmaceutical Online and it can be accessed for free. The reference is:

Sandle, T. (2021) Complying With Batch Release: Auditing Electronic Batch Records, Pharmaceutical Online, March 2021. Access: Pharmaceutical Online at -

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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