Upon meeting the requirements for the initiation of exhibit batches, the Quality Assurance (QA) department shall grant approval to proceed with the execution of the exhibit batch. The execution of exhibit batches will take place, and samples will be collected at various stages of manufacturing and packing, as outlined in the protocol. Any non-conformances identified during the batch execution must be reported in accordance with the site specific Standard Operating Procedure (SOP). The batch will be executed with the approved change control wherever applicable.
Following the execution of the batch, any necessary updates to documents such as the master production record, specifications, and testing procedures, resulting from investigations such as deviation, Out of Specification (OOS), or Out of Trend (OOT), shall be made.
Management of Intermediate:
Upon finishing the intermediate stage of manufacturing, the production department is required to notify the QA department for sampling and analysis, accompanied by a properly completed ‘Request for Analysis’ form. QA personnel will conduct the sampling and submit the sample to the QC department for analysis. The batch may proceed to the next stage only after confirming that the batch record is complete up to the previous processing stage. Once the analysis is complete, the QC reviewer will verify the reports for adherence to intermediate specifications. If the results are satisfactory, the QC executive or a higher authority will authorize the release of the intermediate product and update the status in ERP / SAP.
In the event of any discrepancies, the QC executive or a higher authority must inform the QC In-charge and the Production/R&D/Quality Assurance supervisor to initiate corrective actions. After the corrective actions have been completed, the QC executive or a higher authority will then release the intermediate product.
Management of Bulk Finished Product for Packaging and the commencement of stability study:
Upon the completion of the intermediate stage of manufacturing, the production department shall notify the QA department for sampling and analysis, accompanied by a duly filled ‘Request for Analysis’ form.
The QA personnel shall verify the completed batch manufacturing record for its completeness, collect the sample, and submit it to QC for analysis.
The batch may proceed to packaging only after confirming the completeness of the batch record up to the final processing stage.
Following the completion of bulk-finished analysis, the QC department shall send the duly filled and signed Analytical Report to QA for review. In cases where microbial testing is included in the specifications, QC shall ensure that the analysis is completed.
The Finished Product can be loaded for stability study immediately after the packaging is completed. The QA Reviewer shall verify the QC reports against the product specifications and update the status in ERP / SAP.
Completion of the Finished Product for transfer to the Finished Goods Warehouse:
Upon the conclusion of packing a batch, the production department will generate the Finished Goods Transfer Note and send it to the QA department. Upon receiving the Finished Goods Transfer Note, QA personnel will verify and ensure the following:
- All batch documents are thoroughly completed and duly signed by the responsible individual prior to the transfer stage.
- All in-process verifications are conducted by Production and Quality Assurance in accordance with the Batch Packing Record and the relevant Standard Operating Procedures (SOPs).
- Any incidents that arise are promptly addressed, and corrective measures are implemented.
- Any loose shippers are verified by Quality Assurance.
- Reserve or control samples, along with any other applicable samples, are collected, and their quantities are documented in the batch records.
- The total number of shippers prepared for transfer is counted, and the total quantity is reconciled with the amount specified in the finished goods transfer note.
- If the checks are deemed satisfactory, Quality Assurance will authorize the release of the finished product for transfer to the finished goods warehouse by signing the Finished Product Transfer Note and updating the status in SAP as blocked stock, indicating it is not for commercial use.