As a supplement manufacturer that is adhering to cGMP guidelines, there’s a good chance that you are keeping strict Master Batch Records and Batch Production Records to comply with regulations put forward by the FDA. Instead of keeping file cabinets full of handmade records or relying on computer-based spreadsheets, take the guesswork out and keep records easily with Virtual Office to maintain cGMP certification. In this article, we will look at what these record types are and how our software can help simplify the process.
What are Common cGMP Records?
As previously mentioned, there are two common records that are required to be kept to maintain cGMP certification. While each is somewhat dependent on each other, there are some key differences between the two. Let’s take a look at each of the previously mentioned record types and the role they play in maintaining cGMP certification.
- Master Batch Records – Also known as a Master Manufacturing Formula, MBRs are best defined as general manufacturing instructions utilized by a supplement manufacturer. In fact, each unique formula provided by a supplement manufacturer will need its own MBR with a bill of materials, product name and other defining information. With an MBR, proper ingredients can be added at the appropriate step to complete the product.
- Batch Production Records – As a copy of the MBR, a BPR explains who created manufactured the product, what tools were used, when it was done and the environment utilized throughout the process. The BPR will often also include an indication of weights, measurements and ingredient counts to be considered complete.
How Can Virtual Office Help with Record Keeping?
As an all-in-one, cloud-based enterprise resource planning software, Virtual Office was built with supplement manufacturing and detailed record-keeping in mind. After spending years in the industry, the team at Equitable Software realized how much of a need there was for an easy record keeping solution to maintain cGMP certification. No matter what your current manufacturing processes are, Virtual Office can be customized to meet your unique needs.
Ready to Get Started?
If you are interested in learning more about Virtual Office or want to see how this powerful ERP software can benefit your supplement manufacturing process, we invite you to request a demo and try it for yourself. We are confident that our industry-specific software contains everything needed to help you manufacture your customer’s products faster while keeping manufacturing costs to a minimum.