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PRODUCT TRIAL BATCH MFR No. NA REVISION No. 00BATCH PRODUCTION AND CONTROL RECORD PRODUCT CODE EFFECTIVE DATE BPCR No. NA SUPERSEDE BPCR No. NILBATCH No. PAGE No. 1 of 41BATCH MANUFACTURING RECORD
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How to fill out master batch production record

01
Obtain a blank master batch production record (MBPR) template.
02
Fill out the header section with product name, batch number, and date.
03
List all ingredients and their quantities in the raw materials section.
04
Document the manufacturing process step by step, including equipment used.
05
Record in-process measurements and observations during production.
06
Note any deviations from the standard procedures and actions taken.
07
Include a section for quality control checks performed.
08
Sign and date the document by all personnel involved in the process.

Who needs master batch production record?

01
Quality assurance teams to ensure compliance with regulations.
02
Production managers for tracking batch consistency.
03
Regulatory authorities for auditing and compliance.
04
Research and development teams for process improvement.
05
Training purposes for new employees in production and quality departments.
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A master batch production record (MBPR) is a comprehensive document that outlines the entire manufacturing process of a product, including specifications, ingredients, equipment used, and specific instructions for production.
Manufacturers of pharmaceutical products, food and beverages, and cosmetics are typically required to file master batch production records as part of regulatory compliance to ensure quality and safety.
To fill out a master batch production record, manufacturers should follow standardized procedures, including documenting the product name, batch number, ingredient list, equipment used, specific procedures, personnel involved, and any observations made during production.
The purpose of a master batch production record is to ensure consistency and quality control in the manufacturing process, serve as a reference for production staff, and provide documentation for regulatory inspections.
The information that must be reported on a master batch production record includes product identity, batch size, component quantities, production process steps, equipment used, quality control tests, personnel involved, and any deviations or issues encountered.
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