Run: Tablet Granulation, Compression, and Coating SOP

The supervisor verifies that the approved batch record, material list, equipment status, and prior line clearance are available before any processing begins. The operator records any missing document or unresolved status as a deviation and escalates it before proceeding.

The line leader inspects the granulation, compression, and coating areas for residual product, labels, documents, and tools from the previous batch. The operator confirms that each required machine displays the correct cleaning and release status label. The supervisor escalates any unresolved mix-up risk as a non-conformance.

The operator verifies material identity, lot number, quantity, and expiry status against the batch record. The quality inspector confirms that any quarantined, damaged, or unlabeled material is removed from use and escalated for disposition.

The process technician installs the required granulation components, confirms guards and interlocks are in place, and sets the approved operating parameters. The operator verifies dust extraction, instrument readiness, and equipment cleanliness before loading materials.

The operator runs the granulation step according to the approved parameters and records the actual time, speed, and endpoint observations in the batch record. The line leader checks moisture, appearance, and granule consistency at the defined in-process intervals. The supervisor escalates any out-of-tolerance result as a deviation and holds the material pending review.

The operator transfers granules to the approved drying process and records the start and stop times. The process technician verifies moisture content and particle size after sizing and documents the results. The operator segregates any material outside tolerance for investigation.

The operator confirms the press is clean, cleared, and fitted with the correct punches, dies, and guards. The line leader verifies the tooling identification, machine settings, and reject system before start-up. The supervisor escalates any mismatch as a non-conformance and prevents operation until resolved.

The operator starts compression using the approved settings and records output rate, tablet appearance, and reject counts at the defined intervals. The quality inspector measures weight, hardness, thickness, and other required attributes against the batch tolerance. The line leader stops the press and escalates any repeated deviation, abnormal noise, or sustained out-of-spec result.

The operator verifies container labels, batch identity, and quantity before transfer to the coating area. The line leader confirms the receiving equipment is clean, released, and ready for use. The operator records any damaged tablets or quantity discrepancy as a deviation.

The process technician installs the coating components, confirms spray nozzles, airflow, and temperature controls, and verifies the system is clean and ready. The operator records the approved setpoints and confirms the batch record matches the coating formula and process instructions.

The operator runs the coating cycle according to the approved parameters and records inlet temperature, spray rate, and cycle time. The quality inspector checks appearance, coverage, and any required weight gain at the defined intervals. The supervisor escalates defects, equipment alarms, or parameter drift as a deviation and pauses the process if needed.

The operator reconciles all issued, used, rejected, and returned materials against the batch record. The line leader verifies that all product-contact surfaces are cleaned, labels are removed, and changeover documentation is complete. The supervisor reviews any discrepancy, initiates deviation handling if counts do not match, and releases the area only after verification.