August 14, 2024

Master Manufacturing Records (also known as Master Production Records or MPR’s) are the roadmap for the regulated production journey. MPR’s are pivotal in ensuring that new material creation is clearly defined and accurately documented for executing the resultant Electronic Batch Records (EBR’s). They are crucial as they are a trusted resource, so that the EBR’s will support their produced finished goods confidently in regulatory and commercial inquiries and audits.

Here are the features of MPR’s:

• Heading…..defines the product name, client, author, formulation ID, theoretical batch yield (unique to each MPR) batch size (allowing for loss), product unit of measure, container information, component staging, etc. Supporting document attachability is also helpful.
• Personnel…….users permitted to work on the EBR
• Actions……defines activities by individual and date. Also sends reminders if needed
• Materials……defines inventory components for the batch. Also known as BOM, formula, or recipe
• Equipment……selects equipment for production
• Documents……selects documents to be added into the manufacturing steps as instructions or standard operating procedures (SOP’s)
• In Process Tests…….tests run in the course of production
• Manufacturing Instructions…..the order of production related operations. Can be ordered sequential or parallel with a precedent rule engine.
• Approvals……review signoffs of the entire MPR content.

We at InstantGMP built our software around the CFR requirements, including our systems that utilize MPR’s. We’ve retained this scheme for both operational efficiency and ease of compliance. Since businesses evolve, we’ve added configurability so that MPRs and their components can be versioned or scaled. If you wish to learn more about our MPR design advantage, look here………or just give us a call.
www. instantGMP.com