Review of the batch record is one of the most important jobs in a pharmaceutical company. “If it’s not documented it didn’t happen” is an all too familiar phrase and while the accurate and concise documentation of the sequence of events performed may seem laborious it is a critical activity. It is after all the only evidence that remains after a batch has been manufactured to demonstrate that it was manufactured according to procedural and regulatory requirements. Effective and efficient management of this review process is the key to a successful process. By reviewing the batch record, QA and operations teams have the opportunity to catch errors before the product is released to the public.
One of the most important aspects during the review of an executed batch record is the documentation of any unexpected or atypical events that may have occurred. These should all be accompanied by a written investigation of the atypical event, inclusive of conclusion and a follow up CAPA. The investigation should consider the impact on other batches of the same product or other products and not just the batch in question. Batch review is not just about review of compliance to Good Documentation Practices (GDPs), the critical process parameters (CPPs) and the critical quality attributes (CQAs) assigned to the product being manufactured must also be reviewed for compliance to specifications. Downtime logs, line clearance logs, equipment and room cleaning logs, calibration labels, environmental monitoring data etc. should all be reviewed as part of the batch record review process. It is imperative that production and quality reviewers are trained to review to the same standard and are verifying the same critical parameters.
Nobody likes to be told that they have made a mistake or completed a task incorrectly so the manner in which you approach personnel is more important than you might realise. Avoid using a confrontational approach and ensure that people are empowered so that they are fully engaged. Create a mindset within the company whereby there is an understanding of the importance of accurate and concise documentation of activities. Do not correct errors on behalf of others as this can have a counter productive effect. While it may seem like the most efficient option at the time of batch record review, it will not benefit the long-term goal of improving your batch record right first time metrics. When an immediate correction is not possible due to shifts, holiday leave, sick leave, etc., the reviewer must inform the person who needs to perform the correction; this is typically communicated via a returns sheet or correction sheet and sufficiently details the correction required. Of course, ideally all entry errors should be identified during the department review with no requirement for returns!
Training is probably the most important key to successful batch record review. Similar training plans should be provided to both the Operations and QA departments. An example of a batch record review training plan could include:
- Tour of all operation areas to familiarise the reviewer with the manufacturing process
- Review of a blank batch record
- Observation of a trained batch record reviewer conducting batch record review
- Review of a “mock” batch record with purposeful mistakes under supervision
- Review of a completed batch record, again under supervision until training effectiveness demonstrated
The key elements that must be contained within a batch record are outlined in Eudralex Volume 4, Chapter 4, Documentation, Step 4.20: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/chapter4_01-2011_en.pdf
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