PREPARATION OF BMR AND BPR

Batch Manufacturing Record (BMR)

A BMR is a detailed record of all activities involved in manufacturing a specific batch of a pharmaceutical product. It serves as a critical document for quality control and regulatory compliance. 

Key Components of a BMR:

• Batch Information: Batch number, product name, quantity, and expiry date.
• Manufacturing Process: Step-by-step description of the manufacturing process, including equipment used, parameters, and personnel involved.  
• Raw Material Information: Details of raw materials used, including supplier, batch number, and quantity.
• In-process Quality Control: Records of quality control checks performed at various stages of manufacturing.
• Yield Calculations: Calculations of yield at each stage of the process.
• Deviation Records: Documentation of any deviations from standard operating procedures.
• Signatures and Approvals: Signatures of personnel involved in the manufacturing process.

Batch Packing Record (BPR)

A BPR is a detailed record of all activities involved in packaging a specific batch of a pharmaceutical product. It ensures accurate and consistent packaging practices.

Key Components of a BPR:

• Batch Information: Batch number, product name, quantity, and expiry date.
• Packaging Materials: Details of packaging materials used, including supplier, batch number, and quantity.
• Packaging Process: Step-by-step description of the packaging process, including equipment used, parameters, and personnel involved.
• Quality Control Checks: Records of quality control checks performed on the packaged product.
• Deviation Records: Documentation of any deviations from standard operating procedures.
• Signatures and Approvals: Signatures of personnel involved in the packaging process.

Importance of BMR and BPR:

• Quality Assurance: Ensures product quality and consistency. 
• Regulatory Compliance: Adheres to regulatory requirements and facilitates inspections. 
• Traceability: Enables tracking of product history and identifying potential issues.  
• Batch Release: Provides necessary information for batch release decisions.
• Investigations: Aids in investigations of quality issues or complaints.