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Home » Master Production Records & Batch Production Records Defined


If there was a Good Manufacturing Practices dictionary, the pages that list the definitions for Master Production Records (MPRs) and Batch Production Records (BPRs) would be bookmarked for frequent review. Although manufacturers must create these necessary records and have them on file at all times in order to comply with all FDA regulations, there is often some confusion regarding the specific definitions and exact purposes of each document.

To clarify the purpose of Master Production Records and Batch Production Records and avoid any confusion recording these two similarly named documents, InstantGMP presents this valuable resource that defines MPRs and BPRs, explains their purpose, and lists the required information contained in each.

The Many Names of MPRs and BPRs

Before we define Master Production Records and Batch Production records and go into detail about their specific purposes, we should clear up one bit of information that can lead to much confusion. Master Production Records and Batch Production Records have several professional aliases.

In the manufacturing industry, Master Production Records may also be referred to as Master Records, Master Manufacturing Formulas, Master Formula Records, Master Manufacturing Records and Master Batch Records. Likewise, Batch Production Records may be referred to as Batch Records, Batch Formula Records and Batch Manufacturing Records.

Though they may have many names, Master Production Records and Batch Productions each have their own unique purpose – which we will explain in the following sections.

What Are Master Production Records?

Master Production Records (MPRs) are the most important documents in the manufacturing process. In essence, the MPR is the manufacturing process equivalent of a recipe that lists all of the required ingredients and necessary steps for the production process. Once created, an MPR is set in stone, approved by quality control, and is never changed to ensure consistency, quality, and safety every time a product is manufactured.

Each unique formulation and batch size must have its own unique Master Production Record that includes the following information as per FDA regulations:

  • Identification of product name
  • Bill of Materials detailing the Weight (the measure or count of each component needed to manufacture the batch)
  • Equipment list
  • Component list
  • Statement of theoretical yield at each step in the manufacturing process
  • Expected yield of the finished product
  • Specific instructions for each step in the manufacturing process
  • Sampling and testing procedures
  • Instructions for manual operations

A Master Production Record must be created first as it serves as the template for the Batch Production Record.

What Are Batch Production Records

Batch Production Records (BPRs) follow the manufacturing recipe provided by the Master Production Record to ensure that all of the proper ingredients are added and each necessary step is completed during the production process.

Any time a step in the production process occurs, all of the information associated with that step must be documented in the BPR:

  • How Was each step performed
  • Who performed each particular step
  • Which materials were used in each step
  • What equipment was used in each step
  • Which environment did each step take place in

Operators also use the BPR to record specific lot numbers as well as the specific weights, measure or count of ingredients and components actually used to produce a specific batch. If at any time a deviation in any given production occurs, it must be recorded and explained in the BPR.

Ultimately, a Batch Production Record serves as a controlled record of the process in order to maintain traceability of raw ingredients and good manufacturing practices.
There you have it. Those are the definitions of and differences between Master Production Records and Batch Production Records (or the definitions and difference between batch formula records and master formula records if you prefer).

When you need to create Master Production Records or log Batch Production Records, we can help make your processes easier and more effective with our innovative and user-friendly InstantGMPTM PRO software for MPRs, BPRs and even Make To Order Batch Records.

Contact us today for a live demonstration of our InstantGMPTM PRO software to see how it can make MPR and BPR creation more efficient and accurate for your facility!

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