As a part of international regulatory standards of GMP, pharmaceutical industries are required to maintain documentation of the entire manufacturing process and batch execution process.
Pharmaceutical companies have been traditionally using paper to maintain Batch Records (BR) like Batch Manufacturing Records (BMR), BPR, process and equipment templates etc. in order to comply with the requirements of regulatory standards like FDA, MHRA, etc.
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In this current process, the Batch Records documentation is a manual process, with scores of papers to fill and this is tedious, time-consuming, laborious, monotonous and highly error-prone. A large number of documents are generated and there is a high stipulated retention time for such documents which is posing a great challenge to the industry to manage a highly secured space for storing the documents.
A paper-based forms process like Batch Records can be plagued with inefficiency and issues such as wrong issuance, incomplete information, errors and reworks. A study reveals that Batch Record issuance has huge manual and tedious component of work, often turns out to be source of errors and reworks.
For these manual Batch Records, the information has to be collected correctly and completely. With paper forms, the onus lies with the QA team for error- free templates and on the operator to input accurate and complete information. Though manually collected information helps pharma companies meet regulatory requirements, it is very labour-intensive to collect, review and retrieve the information quickly for compliance and production decision making purposes.