What is a Master Batch Record (MBR) Versus a Batch Record (BR).

What is a Master Batch Record versus batch record

 

In this article, you will learn what is a Master Batch Record (MBR) versus a Batch Record (BR) related to cGMP manufacturing orders and process excellence.

Master Batch Record Definition:

The official written instructions or recipe for the manufacturing of each particular product part number using a specific manufacturing process.  It is a requirement of the 21 CFR 211.188 Batch Production and Control Records. 

The Master Batch Record is intended to ensure that all proper ingredients are added and that each step in the process is completed and documented.

Master Batch Records MBR, (called Master Production Records MPR or Master Manufacturing Formulas MMF), are specific manufacturing instructions. Each unique formulation and batch size must have its own MBR.

The Master Batch Record should require the following information, for example:

    • Identification of product name.
    • Bill of Materials detailing the Weight, 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 state in the manufacturing process.
    • Sampling and testing procedures.
    • Instructions for manual operations.

These documented instructions are required for each unique formulation and batch size to guarantee the standardization and repeatability of the process every time.  Since the MBR is the original template from which copies are taken, it is not filled during the manufacturing process.  It is associated with a production number or part number, but it is not related to any particular lot number.

Please do not confuse the master batch record with the batch record.

Batch Records Definition

Batch Records: An accurate copy or reproduction from a Master Batch Record to be associated with one particular lot number. Since the Batch Record is a copy of the Master Batch Record for each lot to be manufactured, it is filled and contains the evidence that a particular lot was done following the corresponding instructions.

The manufacturing orders involve a documented request (a batch record) issued within a company to produce a specific quantity of material or finished product within a certain timeframe. A production order may be issued pursuant to a sales order, and its issuance triggers a number of events.

If components in the bill of materials are in stock, reservations are generated for those items; if they are not in stock, then requisition orders may be generated to buy them. Requisition orders may also be generated for production that occurs externally to the firm. Planned costs for the order are also generated and capacity requirements are generated for the work floor centers.

Master Batch Records Versus Batch Records

Both Master Batch Records MBRs and Batch Records BRs are a requirement of the FDA to each pharmaceutical and medical devices companies in order to comply with cGMP regulations.

The Batch Record is where operators write the information and register the specific lot numbers as well as the specific weights, measure, or count of ingredients and components actually used to produce that specific batch.

Meanwhile, the Master Batch Record serves as a template for the manufacturing process, the purpose of a Batch Record BR is to show that each specific batch of product was created in accordance with the Master Batch Record and also explain all deviations that may have occurred during the production of any given batch.

The Batch Record serves as a controlled record of the process in order to maintain traceability of raw ingredients and manufacturing practices.

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REFERENCES: What is a Master Batch Record.

https://en.wikipedia.org/wiki/Lean_Six_Sigma

https://www.greycampus.com/blog/quality-management/a-brief-introduction-to-lean-and-six-sigma-and-lean-six-sigma

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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