Paper-based manufacturing batch records are still largely prevalent among most pharmaceutical producers. The manufacturing personnel are required to note down the required values on printed manufacturing record forms. While this may seem like a simple, convenient, and inexpensive method of recording data, it poses a high risk of error. Needless to say, errors in batch records can have severe consequences for the release of drug products. Operators may enter an incorrect reading, forget to complete a required field or miss mandatory signatures for an entry. Necessary attachments such as sample analysis data can be misplaced. The entire paper record itself is subject to damage. A lengthy verification process is required before the documentation can be approved to permit the release of the batch. In cases when the error is initially undetected, it may even result in a product recall. Errors can, however, be minimised through the implementation of electronic batch records. As with any electronic system within the pharmaceutical industry, the electronic batch records also need to meet the requirements of current good manufacturing practice (cGMP) and data integrity. It is essential to include these requirements in the initial design phase of the system.
An electronic batch record can help an organisation benefit in terms of better data accuracy and integrity, efficient operations and streamlined processes. It uses various databases (that store the data recorded during the manufacturing of a batch) and a business process engine (that defines the process to be followed). It has a user interface that shows the necessary tasks along with instructions to operators. This allows them to suitably monitor the operations and record relevant results. Further, integration among systems enables an electronic batch record system to be continually updated with other information about environmental monitoring, test procedure execution, resource planning, manufacturing execution, product lifecycle and so on. With these sets of data becoming part of the batch record, the risk of error can be significantly reduced and helps improve compliance. It can also be a source of data for annual product quality reviews that are required to be submitted to regulatory authorities. It can resolve the limitations of paper-based batch records and eliminate cumbersome activities that operators are required to perform.
An electronic batch record solution helps track data (on the number of batches manufactured, the yields of those batches, changes made to them if any, analysing the effectiveness of such changes) easily, and that can generate useful insights. Using a paper-based system, gathering these data can be extremely long and cumbersome, entailing a loss of unnecessary time. To optimise batch record reporting, integration is necessary between the batch record system and other enterprise information systems. It is essential for pharmaceutical manufacturers to understand that all the data generated are a part of the continuous workflow and are not discrete silos. As such, companies should consider adopting a model that focuses on the organisational workflow as a whole, based on a central system of record.
Electronic batch records present a very streamlined process that is more reliable than a paper-based system, is much less prone to error, and a means to assess and release pharmaceuticals. An integrated solution that helps integrate data from batch records with databases from other systems support the free flow of information within the organisation, providing valuable insights.
