MMR (Master Manufacturing Record) is the cornerstone of manufacturing quality control systems with a focus in process manufacturing of food, drugs and like items. MMR documents the details manufacturers must follow throughout manufacturing process to ensure uniform and high-quality products. This blog post delves into what MMR is in manufacturing, its key components, MMR template, the difference between a Master Manufacturing Record (MMR) and a Batch Manufacturing Record (BMR), and why manufacturers require MMR.
What Is a Master Manufacturing Record (MMR) in Manufacturing?
A master manufacturing record (MMR), also known as a master batch record (MBR), is comprehensive document for manufacturers that outlines the details related to the manufacturing process. Master Manufacturing Records (MMRs) are essential in industries like pharmaceuticals, food and beverages, chemicals, and supplements, where regulatory and quality requirements are paramount.
MMRs provide details, including procedures, manufacturing instructions, formulas, process steps, and quality control details to produce a product. Manufacturers need MMRs to ensure batch production is consistent and of high quality. MMRs are a critical part of a Current Good Manufacturing Practices (cGMP) strategy as wee as meeting FDA’s standards for dietary supplements. For each unique dietary supplement manufactured, an MMR must be recorded and documented for each unique formulation and batch size.
What Is Included in the Master Manufacturing Record (MMR)?
A manufacturer must include the following in the Master Manufacturing Record:
1. Name of the product and its description. It could be a product’s unique ID or code.
2. A complete list of materials or components that will be used to manufacture the product.
3. An accurate statement of weight and measure of the component or material used.
4. An identity of weight/measure of ingredient.
5. A statement of the intentional overage amount of ingredients. It refers to the addition of an extra quantity of ingredients to account for potential ingredient loss in the manufacturing process.
6. A statement of theoretical yield is expected at each step of the manufacturing stage.
7. A description of the packaging label and a representative label.
8. Written instructions of specifications for each manufacturing stage where quality control is necessary. It should also include sampling procedures, specific actions to perform and verify at each manufacturing stage where quality control is essential, labeling verification details, and verification of weight/measure of ingredients.
9. Manual instructions for specific actions include one person recording and verifying; one person adding the ingredient/component, and another person verifying the addition, specific notations or precautions to be followed, and corrective action plans if a product does not meet the specifications.
Download the Free MMR Template
Download a Free Master Manufacturing Record (MMR) Template. Manufacturers can use this MMR sample to build their own MMR specific to their needs and requirements.
What Is the Difference Between a Master Manufacturing Record (MMR) and a Batch Manufacturing Record (BMR)?
In the manufacturing industry, Master Manufacturing Record is also known as Master Formula Records, Master Records, Master Manufacturing Formulas, Master Batch Records, and Master Production Records. Likewise, Batch Manufacturing Record has different names, such as Batch Production Records, Batch Records, and Batch Formula Records. Let’s understand how Master Manufacturing Record and Batch Manufacturing Records are different from each other.
- Master Manufacturing Record in manufacturing is a document that manufacturers follow to produce a final product. It details the ingredients, quantities, tools, equipment, steps to follow, quality control specifications, and more to ensure the product is produced correctly as per the specifications.
- Batch Manufacturing Record includes each and every detail to an item. It includes the type of tools used, brand name of ingredients, type of ingredients used, time duration to produce a batch, production number details, lots produced, and other details related to at each step of the manufacturing process. Deviations and corrective action plan details must be recorded when deviations are observed.
Each manufacturing company may have its own unique version of the Master Manufacturing Record (MMR), as it is a documentation for a specific product. Regulatory requirements can vary by region or product type; hence, the Master Manufacturing Record (MMR) may vary. Batch Manufacturing Record (BMR) typically follows the Master Manufacturing Record (MMR) template for a specific production order. Master Manufacturing Record is the plan, and Batch Manufacturing Record is the execution of the plan.
Best Practices To Develop Master Manufacturing Record in Manufacturing
Here are a few best practices that manufacturers can follow to develop a Master Manufacturing Record (MMR):
1. Ensure MMR complies with industry-specific regulations such as FDAs cGMP(Compliance Good Manufacturing Practices) or ISO 9001.
2. Document details of every critical manufacturing step.
3. Ensure that all the instructions are outlined clearly and in detail, from raw material selection to final packaging.
4. Define critical control points and quality control checks required at each manufacturing stage. Document test procedures to follow and acceptable criteria of the product.
5. Outline risk mitigation measures and contingency plans for non-conformances.
6. Ensure to add reference document details or unique numbers for any specifications or labels.
7. Schedule periodic reviews and update the MMR to align with the updated processes and regulations. Ensure proper communication across teams regarding the updated MMR.
8. Train relevant personnel on how to use MMR effectively and make it easily accessible.
Why Do Manufacturers Require MMR?
Below are listed the requirements to develop a Master Manufacturing Record (MMR) by manufacturer:
- To ensure uniformity in the finished product from batch to batch.
- To identify the specification of each manufacturing step.
- Establish control and procedures to ensure the product meets the specifications.
- To meet regulatory requirements and guidelines throughout the manufacturing process.
Final Thoughts
MMR and BMR are both critical in process manufacturing industries such as supplements, pharmaceuticals, food and beverage, chemicals to ensure the quality of items produced. Maintaining these records help to ensure the product meets industry, regulatory, and compliance requirements.
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