Batch Master File: Master Manufacturing Records (MMR) & Batch Production Records (BPR)

  

Master Manufacturing Records (MMR) and Batch Production Records (BPR) are essential for ensuring compliance and maintaining product quality in the supplements industry. These records are key role in product quality and safety, and they guarantee your commitment to regulatory compliance.

We provide MMRs & BPRs review service, including comprehensive consulting to ensure compliance with relevant regulations, outlining the necessary components and their differences.

Production and Process Control System: Requirements for Master Manufacturing Records (MMR)

Master Manufacturing Records (MMR) provide comprehensive instructions for manufacturing regulated products, serving as a reference for each specific batch. Maintaining MMRs is vital for documenting deviations and tracking batch-specific data in case of issues. The MMR includes the complete manufacturing procedure, covering formulation, theoretical yield, processes, assay requirements, and labeling. It also records product amounts used, quantities produced, and verifies inventory of components.

 

Key MMR Components

ㆍ      Product name and ingredient measurements for each batch size

ㆍ      List of all components with accurate weight or measure statements

ㆍ      Quality control points and expected yields at each manufacturing stage, including limits that trigger investigations

ㆍ      Description of packaging and representative or actual labels

ㆍ      Written instructions for critical steps in the manufacturing process, including quality assurance and labeling requirements

ㆍ      Verification procedures for manual tasks, such as component weighing and addition

ㆍ      Corrective action plans for instances where specifications are not met

 

Production and Process Control System: Requirements for Batch Production Record (BPR)

Batch Production Record (BPR) is a real-time document that captures the production of a specific batch, tracking every step, ingredient, and quality check to ensure compliance with established guidelines. BPRs are crucial for quality assurance and regulatory compliance, providing evidence that each batch was manufactured according to the procedures outlined in the MMR. They create a link between the MMR and the final product, ensuring transparency and traceability.

ㆍ      Prepare a BPR for every manufactured batch of dietary supplements.

ㆍ      Include comprehensive details on production and quality control for that specific batch.

ㆍ      Adhere to the guidelines set forth in the MMR.

ㆍ      Ensure compliance with regulatory standards.

Our Service for Food & Dietary Supplement (Health Functional Food) Product      

	GAP Analysis		Ingredients and Label		Registration
	U.S. Agent		Facility Inspection		Food Safety
	Batch Master File		GRAS, NDI and Novel Food		Food Contact Substance

K-GMP supports international clients in safeguarding the quality, safety, and performance of their supply chain, ensuring full regulatory compliance from raw materials and ingredients through to packaging and final products.

K-GMP network offers a comprehensive range of 1:1 customized consultancy support for all types of food products. We are committed to staying up-to-date with the regulatory environment, trends and industry requirements.

For detailed information about each of the services above, contact directly our expert.

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