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> batch manufacturing record
batch manufacturing record
Pre-Manufacturing Preparation
Verify product specifications and formulation.
Ensure all raw materials are available and within expiration dates.
Confirm availability of manufacturing equipment and tools.
Review and approve batch manufacturing record (BMR) template.
Train staff on specific procedures and safety protocols.
Equipment Setup
Clean and sanitize all manufacturing equipment.
Inspect equipment for proper functioning and calibration.
Set up equipment according to the BMR specifications.
Document equipment setup and any deviations from standard procedures.
Material Handling
Weigh and measure raw materials according to BMR.
Label all materials clearly with batch number and relevant information.
Conduct quality checks on raw materials before use.
Document any discrepancies in material specifications.
Manufacturing Process
Follow the BMR step-by-step during the manufacturing process.
Record all in-process parameters (temperature, pressure, time).
Monitor critical control points and take corrective actions if necessary.
Document any deviations or incidents during manufacturing.
Post-Manufacturing Procedures
Conduct quality control tests on the final product.
Document results of quality control tests.
Clean and sanitize equipment after manufacturing is complete.
Review and finalize batch records for accuracy and completeness.
Documentation and Reporting
Ensure all records are signed off by authorized personnel.
Submit batch records for review and approval.
Archive batch manufacturing records according to company policy.
Prepare a summary report of the batch manufacturing process for stakeholders.
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