Wednesday, 3 March 2021

Important cGMP Considerations For Implementing Electronic Batch Records


While human error is never the ultimate root cause, mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. In more serious cases, when the error is initially undetected, the consequence can be a product recall. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met. These essential requirements need to be included in the initial design phase of the system.

In relation to this topic, Tim Sandle has written a new article for Pharmaceutical Online, titled "Important cGMP Considerations For Implementing Electronic Batch Records"

The article can be found here: Electronic Batch Records

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

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