If your cannabis or dietary supplement business is in production, you’ll need to ensure that you keep excellent records to document and guide each step of manufacturing. The batch production record, or BPR, is one of the most important forms that your facility workers will need to fill out. Batch production records are a crux of any quality assurance system and are necessary to abide by Good Manufacturing Practices, or GMP.
One batch record must be created for each batch product or supplement. This record must contain full information relating to the production and control of each batch. Each step of production must be fully outlined and explained so that personnel are guided in every aspect of the production step.
When you’re creating a batch record for your company it should include certain details. There should be space for the batch and a lot or control number of each batch lot that is packaged. This also includes the lot numbers of any ingredients added to the batch.
Your BPR needs to also include the identity of the equipment used, and the production lines for each batch.
Dates and times will also need to be recorded of when your equipment has been cleaned, sanitized, and maintained. There may need to be cross-references provided of the individual equipment logs where the info is stored.
You will also need to record a unique identifier that has been assigned to each component or ingredient, even when received from an outside source, that goes into the creation, packaging, or labeling of the supplement or cannabis product.
The weight or measures of each component or ingredient will need to be recorded. There will also need to be a statement of your actual yield and the percentage of theoretical yield at various stages of processing.
When you have done your monitoring operation you’ll need to record results, or the results of any testing done.
Besides recording the name of the worker and the date, there will need to be initials of the person who has performed each step, including the weighing and measuring of each component in the batch, and the initials of the person who has added an ingredient to the batch.
When the quality control department has examined the batch, this information will also need to be recorded. This information should include personnel names, and information about any monitoring operations, tests, and examinations.
If the batch has been approved or rejected or needs to be repackaged or reprocessed, this information must also be written on the batch record.
Approvals and releases need to be determined by the Quality Assurance, or QA, department and must be recorded.
If multiple copies are needed of the batch production record, a process may need to be set in place for duplication or for scanning or creating digital copies to ensure duplicate records are not used.
As you can see, designing a batch production record can be a long and tedious process, and is quite complex and confusing.
If you’re stuck and need assistance, Compliance Naturally can be hired to assist you through every step of the process in achieving compliance with the FDA and Good Manufacturing Practices required to have a safe and well-functioning cannabis or dietary supplement facility.