Caliber Electronic Batch Record Management
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. 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.
In today’s knowledge -based world, information is the greatest asset and quick use of information for improvement is the key to business success. Manual systems don’t connect forms-based processes like audit findings, corrective action, etc. making continuous improvement almost impossible. It is also nearly impossible to analyse and correlate significant volumes of information necessary to improve production processes. Globally, the pharma industry has the need for timely and accurate manufacturing information that can be collected, stored, retrieved, analyzed and reported more readily. The only option for efficiently managing these Batch Records is to automate the process.
21CFR Part 11 guidelines and automation of Batch Records With the advent of 21 CFR Part 11, the FDA has begun to accept electronic Batch Records. Since then, more and more manufacturers have recognized the advantages of automating the process of controlling Electronic Batch Records (EBR).
Under cGMP regulations found in 21 CFR Parts 210 and 211, the Electronic Batch Record (EBR) must demonstrate the accomplishment of every significant step in the production, packing, and holding of each batch of a drug product. cGMP requires extensive Batch Record documentation, including batch dates, identity of major equipment/lines used, components / materials used and their weights, in-process and laboratory control results, complete labeling control records, sampling, and identification of personnel supervising or checking each step.
In addition to what cGMP requires, manufacturers that automate their Batch Records must do so in accordance with 21 CFR Part 11 requirements.