Quality should be “built into” the product. It means that during product manufacturing, it is better to take measurable actions to ensure performing an operation correctly, rather than working on it again to correct mistakes. Production rework is always something that might be necessary in manufacturing operations, but if it happens quite frequently, it could not only hurt the bottom line but also point to a problem with systemic inefficiencies. When we talk about the Batch Record,there are several areas which may contribute to rework in operations: 1. Production reworks: correcting defective products to make them acceptable
2. Batch record reworks: correcting the record due to missing or incomplete required GMP information which prolongs the review process
All of the above issues are inevitable on paper-based operations, it’s simply because of inherent risks of a manual paper-based process, over which there is little control. All the aforementioned issues, especially those relating to data integrity, can be resolved by putting in place an eBR system. Blocks and checks can be set up using computerized systems to make sure that no data elements necessary to build the electronic batch record are missing. In doing so, it is also possible to sequence and lock data entry so that data items are only present and available for input at the time of generation, rather than entered retrospectively, assuring the desired integrity of the data. The usage of electronic batch records also enables Right First Time by providing quicker feedback, for instance in the case of input errors or exceptions. The ability for many parties to act and interact with the batch record simultaneously also ensures better collaboration, more accurate data, and, as a result deliver higher product quality and efficiency. How eBR systems help to ensure Right first timeHow eBR systems help to ensure Right first time
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November 2023
Digitising Batch Records is becoming easier for GMP Manufacturers
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