Batch Records; Tool or Torture?

Welcome back for another Technical Tuesday! We have talked a lot about compliance and documentation, and today will be no different! We all start with compliance in the regulated Cannabis industry, that is why we feel it cannot be understated the importance of not only establishing, but also maintaining a compliant Quality Management System. This week we are going to discuss Batch Records, and more importantly, why you need to have a fully electronic Batch Record (EBR).

If you have been within 10 feet of a Quality-controlled production facility you’ve no doubt heard the term “If it’s not written down, then it didn’t happen”. Documentation is the foundation of a GxP compliant Quality Management System. A Batch Manufacturing Record (BMR) or a Batch Production Record (BPR) should include all relevant documentation to demonstrate that this process was completed according to the Master Production Instructions. Batch Records should be prepared, and verified, upon the completion of a manufacturing or production run.

There in lies the rub, depending on what part of the Cannabis value-chain being completed, a Batch Record could be open anywhere from a few hours to 18+ weeks. The efficiency and speed of the business requires that time not be wasted with getting a Batch record verified and approved. This is a common spot in the production process where bottlenecks can occur due to backlogs of Batch Records waiting to be reviewed. There is a lot of data to sort through and validate, getting this process right is crucial. Applying pressure incorrectly to this process can have a negative effect on the business and increases the risk of non-compliance.

Having all the business data funnel into an electronic Quality Management System enables real-time authoring and validation of data. An eQMS can reduce the occurrences of illegible data entries and empty or missed fields, saving time and money in the Batch Record preparation, review, and approval process. Having an always accessible electronic Batch Record provides greater visibility to all interested departments and stakeholders. Alerts and Notifications can keep teams aware of any changes or updates to the Batch Record, such as the moment when test results have been reviewed and posted. That near-instant level of knowledge transfer could reduce inter-departmental engagement time enabling you to get your product to the market faster, creating efficiencies resulting in better returns and lower working capital needs. In today’s uncertain times, an electronic Batch Record could create more opportunity for companies to leverage their Work from Home policies, reducing their on-site headcount and ensuring business continuity.