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 specifies 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 record production and review 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. Below are a few of the common problems manufacturers may face and how they can be solved with purpose-designed tools.

Unreliable reports

Many manufacturers start out with the best intentions when selecting a reporting system that appears accessible and cost-effective. However, many reporting solutions are not expressly designed to manage mission critical reporting. What starts out as a cost-saving measure can rapidly become a headache for a manufacturer when reports meant to process large amounts of information run prohibitively slow or outright fail. When critical reports fail, huge cost penalties are faced.

Manufacturers benefit from selecting purpose-built batch reporting tools that are designed to handle very large, complex data sourced from multiple systems. Reporting software designed to generate extremely large documents common for many manufacturers’ batch records will speed the batch release process instead of holding it back.

Ensuring regulatory compliance

It goes without saying that regulatory compliance is essential when it comes to producing batch records. However, not all facilities use a product developed specifically to be GMP-ready.

When batch reports are generated by reporting software not developed expressly for GMP compliance, regulatory risk is introduced. Non-GMP products might lack a sufficient audit trail, FDA compliant signatures, and the ability to restrict user access based on role. Some batch record software solutions are not able to access and aggregate all the information required for these records in one place.

But when a software specifically designed to conform to FDA regulations is used for reporting, companies can confidently eliminate these data integrity risks.

Disconnected and complex data

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.

A batch record might include a batch report, which may retrieve 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 comes from so many sources, combining it for review can be a challenge. 

Some manufacturers look to integrators to solve their reporting woes, but struggle with cost. Other reporting solutions require manufacturers to replicate data into their MES, resulting in data integrity issues. 

An alternate approach is to use a hybrid system that combines information in its native form, regardless of where and in what form the data is stored. With a flexible, highly connective electronic reporting tool that doesn’t replicate data, data can easily be organized in one place without data integrity concerns.

Inaccessible data

When manufacturers run into above issue with disconnected and complex data, another problem emerges: the inability to truly understand the data they have. Without the ability to connect and appropriately contextualize all their batch record data, manufacturers risk missing crucial trends. Without this information, making fully informed manufacturing decisions is a much greater challenge.

Software that can make all a manufacturer’s data accessible ensures that all decisions going forward are backed by knowledge.

The Bottom Line

Many of the issues faced by manufacturers producing and reviewing batch records can be solved by choosing an appropriate solution to aggregate those records. A highly flexible reporting solution empowers manufacturers to create compliant, complete, and reliable records, increasing productivity and lowering costs.

Informetric Systems offers reporting software purpose-designed to address each of these issues. To learn more about our solutions, contact our team.