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

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.   Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your GMP records activities fast and easily.

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.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. Rest assured of the safety or being in the right hands.

Our Lean Manufacturing team could provide you a broad range of professional expertise implementing these techniques and tools.

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Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You Formal Training about what is a Master Batch Record.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES: What is a Master Batch Record.

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

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