Master Production Records

A requirement common to FDA-regulated industries is a master production record (MPR). They are also known as master batch records or master manufacturing records. Master production record is the critical design details for the derived batch records (electronic batch records) that capture production documentation.

Think of an MPR creator as a workshop for an EBR. More detail on both: master batch records and batch production records is defined.

An MPR generator is a key part of a compliant Manufacturing Execution System, as required by the CFR’s. Here are some benefits of automating the MPR process:

• Better time to completion
• Elimination of human error
• Quality of the end MPR enhanced
• EBR design options often improved
• Advantaged overall ease of use
• Leverage additional benefits of 21 CFR Part 11

Why InstantGMP’s MPR workshop stands out, and factors in

While the CFR requirements for an MPR are the same for all automation providers, actual “EBR buildability” varies significantly with the design of each.

Early on, InstantGMP adopted software design directly from the CFR directives. The MPR and resultant EBR were the starting points. We’ve never altered that basic concept, only extended its capabilities. It offers a powerful way of making the required documentation, as well as improving the management of production resources.
Over years of experience, we’ve added some important extensions and configurability to the workshop to better the MPR process:

• Dynamic field toolkit for
  • additional capture throughout the production process
  • operational calculations at the step level
• Start Stop Operations Timer
• Optional performer and Verifier signoffs
• Maximum and minimum limits for materials from inventory
• Scaling existing MPR’s to new batch yields
• Copying and editing existing formulas, work instructions etc. to expedite new MPR’s
• Costing (material, labor, testing, etc.)
• Easy conversion of a Make-to-Order Electronic Batch Record to an MPR
• Connecting resource-based workflows and information for management in the EBR, as part of a system-wide integrated operational design

We at InstantGMP will continue to develop useful enhancements to our systems…that’s our purpose and remains our goal. Reach us at www.instantgmp.com

REFERENCES
“Better Compliance through Master Production Records” (Soltero)
CFR Code of Federal Regulations—FDA Sec. 211.186