Batch Records & Regulatory Guidance
Both American and European regulatory bodies publish guidelines for Good Manufacturing Practices that detail proper protocol for pharmaceutical manufacturing. According to FDA CFR 21 Part 211, “Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.”
The FDA also details requirements for who must review these batch records, and when: “All drug production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.”
Many pharmaceutical manufacturers handle batch release with tools not intended for that purpose, resulting in challenges aggregating the required batch record documentation and in working through the review and approval activity associated with batch release.
No matter what stage data is in—paper, files, electronic logs, embedded databases, or automation systems—wrangling the wide variety of data sources that impact batch records is never easy. There can be so many systems capturing data, and they aren’t necessarily incorporated into a single repository. It is important to connect those systems and contextualize that information in a meaningful way.
Disconnected Data Sources & Batch Record Review
A batch record can include data aggregated from many disconnected sources. A batch record might include a batch report, which may incorporate context from the batch historian/MES, data from the process historian, or alarms from the event log. The batch record may also include a bill of materials from an ERP, equipment logs from the control system, alarm annotation, or PDF or CSV records from equipment skids.
When data like this is not necessarily incorporated into a single repository, combining it for review can be a challenge. Initiatives to create data lakes or data warehouses, while noble in concept, have generally fallen short of being viable for batch records. Compliance can’t wait for big data initiatives and complex integration. An alternate approach is to use a hybrid system that combines information in its native form, regardless of where and in what form your data is stored.
Some sites manually inspect individual documents, a time-consuming and inefficient process. With a comprehensive report or single workflow to review everything related to batch release, conquering batch record review becomes an easily achievable goal.
Software Solutions
InfoBatch® for EBR
InfoBatch was designed from the start to address reporting and regulatory issues facing pharmaceutical manufacturers. InfoBatch enables life sciences manufacturers to create comprehensive electronic batch records without the cost and complexity often associated with EBR. Since InfoBatch can contextualize process data from virtually any source, it has proven to be a useful tool for process optimization and analytics. As a result, InfoBatch can play an important role in enabling lean manufacturing initiatives that are becoming more and more critical as the industry continues to consolidate and rationalize facilities.
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AgileDoc® Workflow for EBR
Imagine the time and cost savings if all aspects of batch record review and approval were completed electronically? More and more manufacturers have a call to automate their approval process while still meeting regulatory requirements and maintaining good manufacturing practices. AgileDoc® Workflow creates an expansive GMP context-based document review system to safely manage electronic records, attach associated documents and review process history. It provides an organized approach to collecting completed batch reports and routing to multiple departments for electronic review and approval.
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InfoLog® for EBR
Manufacturers subject to GMP are required to document system modifications as well as operational changes that could affect electronic records. One type of record a facility may wish to include in a report is equipment events, which include atypical events such as alarms. Common automation systems may not have a way to intuitively tie user input back to its alarms in a report. For this purpose, an electronic logbook application like InfoLog® can be useful.
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Resources
No matter what stage your data is in—paper, files, electronic logs, embedded databases, or automation systems—wrangling the wide variety of data sources that impact batch records is never easy. There can be so many systems capturing data, and they aren’t necessarily incorporated into a single repository. You need to connect those systems and contextualize that information in a meaningful way.