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pharmaceutical tablet manufacturing

Pre-Production Checklist

Verify availability of raw materials and packaging materials

Ensure all equipment is functioning properly

Review batch records and SOPs for accuracy

Perform equipment calibration and maintenance checks

Conduct a risk assessment for each step of the manufacturing process

Review and approve all manufacturing and packaging instructions

Verify cleanliness and readiness of production areas

Confirm that all necessary personnel are trained and qualified for their roles

Verify that all required documentation, including batch records, labels, and packaging inserts, are available and accurate

Granulation Process Checklist

Check granulation equipment for cleanliness

Verify proper mixing times and speeds

Monitor granule size and moisture content

Ensure correct ingredients are used according to batch record

Conduct in-process checks for uniformity of granules

Record and document granulation process parameters

Perform granule flow testing

Check for any deviations from standard operating procedures

Conduct equipment calibration and maintenance as needed

Compression Process Checklist

Calibrate tablet press machine

Check tablet weight and hardness

Verify proper punch and die sizes

Ensure proper lubrication of the tablet press machine

Monitor tablet compression speed and adjust as needed

Inspect tablet press tooling for any damage or wear

Record tablet compression parameters such as pressure, speed, and dwell time

Conduct in-process checks for tablet uniformity and thickness

Perform cleaning and maintenance of tablet press machine after production

Label and store finished tablets in appropriate containers

Dispose of any rejected tablets according to company procedures

Coating Process Checklist

Ensure coating solution is properly mixed

Monitor coating thickness and uniformity

Verify drying time and temperature

Conduct visual inspection of coated tablets for defects

Perform dissolution testing on coated tablets to ensure proper release of active ingredient

Record batch information and parameters for documentation

Clean and sanitize coating equipment before and after use

Conduct in-process sampling and testing for quality control purposes

Maintain accurate records of coating process parameters for traceability

Packaging Process Checklist

Verify correct labeling and packaging materials

Ensure proper sealing of packaging

Check batch coding and expiry dates on finished product

Conduct visual inspection of finished products for any defects or damage

Verify correct quantity of tablets in each packaging unit

Ensure proper placement of desiccants or moisture absorbers in packaging

Perform weight checks to ensure uniformity across packaging units

Conduct barcode scanning to verify accuracy of product information

Verify packaging integrity through leak testing or seal strength testing

Record packaging process parameters and results for documentation purposes

Quality Control Checklist

Perform in-process testing for uniformity and dissolution

Conduct final product testing for potency and impurities

Review and approve batch release documentation

Verify that all raw materials used in the manufacturing process meet specifications and have been properly stored

Ensure that all equipment used in the manufacturing process has been properly calibrated and maintained

Conduct regular environmental monitoring in the manufacturing area to ensure cleanliness and compliance with regulations

Perform visual inspections of the tablets to check for defects or imperfections

Conduct stability testing to evaluate the shelf life of the product under various storage conditions

Review and analyze all production records to ensure accuracy and compliance with standard operating procedures

Conduct audits of the manufacturing process to identify any potential areas for improvement or corrective action

Verify that all labeling and packaging materials meet regulatory requirements and accurately represent the product

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