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  • Drug Manufacturing

What is Review by Exception?

Through the stages of raw material to the final product, every process and material must meet the highest quality standards.  This is especially true for an industry like Pharma. While dealing with products that directly affect life, there is no scope for a mistake or error at any stage. Therefore, raw material and final product reviews play an important role at every stage.

Let’s take the batch management as an example. During every stage, the sample analysis is conducted by the QC and a report with the details is sent to the reviewer. This is usually quite a long document. The reviewer must carefully go through the entire content and identify the errors or deviations. Once these are identified, the document is sent back to QC. Time is now lost both in recording the information and also reviewing it. As a result, the product release is delayed.

In order to overcome this, the “review by exception” concept is brought into picture. With this approach, review is done only on the specific targeted areas. With this, the target portions of the document are highlighted, making the process of review easy.

Automation is Key to Faster Product Release

Automating the manufacturing process is crucial to getting the product to the patient faster. Review by Exception cuts out redundant review time. By collecting real-time information from different sources, the system highlights all the elements which fall out of specification or do not adhere to a set expectation. When this happens, the review will need to be done only for these highlighted items. This makes the product release quicker and helps the process move faster and smoother.

Document Review with Highlighted Exceptions

When “review by exception” is triggered by the Batch Records Management system, the document generally appears in the following format helping in easy identification of errors to be checked.

1. The content in black need not be checked by the reviewer as it is as per the SOPs

2. The content in blue relates to the data entry errors

3. The content in red highlights the areas to be focused on

With this, the document review is easier and products can be released to the market faster.

Ask for a demo of CaliberBRM now.