In-process monitoring and analysis of Manufacturing & Packing activities of Tablets and Capsules.
Ensure compliance to cGMP Regulations, established SOPs, FO/MI and PO/PI and for all operational activities, area and equipment.
Perform QA review of executed batch production records and ensure the submission of Batch production record in the document cell.
Calibration & maintaining documentation of In-process Quality Assurance (IPQA) instruments.
Data back-up activities of IPQA instruments as per defined SOP frequency.
Monitor the environmental conditions mentioned in the batch production record and SOP.
Certification of batch production records for compliance and stage-wise compliance.
Reporting any GMP related discrepancies, non-conformances and deviations to superiors immediately.
Collection and entry of data for APR preparation.
Imparting training to team members and subordinates.
Ensure physically that the area and equipment to be used for manufacturing and packaging of next product/batch are free from any material/remnants of previous product.
Ensure to prevent mix up and cross contamination.
Check for proper environmental conditions with respect to temperature, Relative humidity, differential pressure etc.
Ensure that the Batch Production record is completed up to the previous stage.
Verify the material with respect to the container labels and quantity from the batch production record.
Ensure the calibration of instruments for in-process checks.
In-process checks as per the approved manufacturing and packaging instructions.
Enclose all the printouts generated during in-process checks along with the batch production record.
All printouts shall be duly signed after checking.
Inform the production manager, supervisor and quality assurance manager about the in-process failure observed during in-process checks.
To record all the observations in the Batch Production Record
Inspection of the Tablets/Capsules as per SOP.
Inspection of the Finished Goods as per SOP and clearance of Transfer Ticket by ensuring the quantity and batch details.
Ensure for usage of appropriate sampling tool for sampling.
Ensure sampling device cleaning prior to the sampling.
Sampling procedure to be followed as per SOP No. SOP019995 (Sampling of intermediates, finished product and stability samples) & SOP020059 (Collection and shipment of Analytical samples of EU market).
Ensure sampling of in-process finished product, process validation, cleaning validation, control samples, EU Lab testing samples & stability samples, Reference & Retention sample as per SOP.
Approval of coding pattern on immediate pack and secondary pack to be verified as per the approved packaging instructions / written procedures.