Batch reconciliation in pharmaceutical industry
- SOP covers below points:
- Reconciliation of packaging materials, Raw materials and Finished Products
- Reconciliation procedure of product
- Yield reconciliation
1.0 OBJECTIVE :
- To describe a procedure for reconciliation of raw material, packing material and product.
2.0 SCOPE :
- This procedure is applicable to reconciliation of dispensed/issued material, semi finished, and finished product at various stages during production.
3.0 RESPONSIBILITY :
- Production chemist and above
- Quality Assurance officer and above
- Quality Assurance Head
5.0 PROCEDURE :
5.1 Start processing after receipt of material as per BMR and BPR. During processing/ handling / subdivision, some process loss occurs. These losses must be within limits and accounted for.
5.2 Ensure that reconciliation of all materials have been accounted for and there is no inadvertent mix-up occurred. Reconciliation helps detect errors at the time of manufacture.
5.3 Start the batch manufacturing as per BMR (Batch Manufacturing Record) and batch packing as per BPR (Batch Packing Record).
5.4 During manufacturing process if additional raw material is required in case of quality issue, incidents, deviations etc. considering above practice which are not common, then with proper justification fill Annexure No.: 01 and for packaging material fill Annexure No.: 02.
5.5 After getting necessary approvals from departmental heads like production, commercial, Quality, Director etc., additional material as per the request is issued to the production department.
5.6 Weigh / count intermediate, finished product after each significant stage and compare the weight (yield) with expected yield. The yield of product is indicator of well defined and controlled process.
5.7 Reconciliation is to be done at the end of each stage, especially important if the products are moved from one section/ department to another. Final reconciliation shall cover the whole process.
5.8 The reconciliation calculation is based on actual figures. The limits are estimates based on expected product loss.
5.9 Reconcile the batch yield at the end of manufacturing process.
5.10 Return the left over product- specific empty hard gelatin capsules in properly labeled and packed condition to warehouse department with “Goods Return Note”.
5.11 Return batch unprinted left over packaging material in properly labeled pack with “Goods Return Note”.
5.12 In case of beyond limit finished product yield, fill a deviation form and follow Handling of Deviation – SOP.
5.13 Roll of film/foil are issued in terms of whole roll(s) in excess of quantity of BPR and such total quantity is recorded in BPR. The left over is returned back to warehouse properly labeled and packed with “Good Return Note”.
5.14 At the end of each specific packing of a batch or part-batch, the printed components and product will be tallied by the packing supervisor/ chemist, e.g. labels, cartons, leaflets, tablets, etc.
5.15 The components is to be reconciled as % yield (and in kg), comparing the number at the start with the number at the end of the process including all waste that occurred during the process.
5.16 All components and products is reconciled 100%, however, allowances are made (Tolerance limits) to allow for counting error and/or minor inconsistencies.
5.17 Any unusual situation and out-of-tolerance tally must be investigated immediately on checking the reconciliation.
5.18 In the case of the out of the range result, a recount must be done and the entries corrected. If the % yield is still outside the allowable limits a thorough investigation must take place to ensure the cause of such a deviation to establish that no mix up has occurred.
5.19 Yields outside the set tolerances must be explained in a Deviation Report and investigated. The investigation shall extend to other batches of same product or other suspected/ associated product(s).
5.20 In case where material for destruction is not owned by Manufacturer and if it belongs to contract manufacturer then contract manufacturer’s management written permission shall be taken before destruction.
5.21 Reconciliation is a part of batch approval before dispatch and indicates recovery of 100% material.
|Standard Operating Procedure
|Batch Manufacturing Record
|Batch Packing Record
|Format For Requisition for Additional Raw Material
|Format For Requisition for Additional Packaging Material
8.0 SOP REFERENCES
- GMP Guidelines
END OF THE SOP
Annex. No. 01 Format For Requisition for Additional Raw Material
Annex. No. 02 Format For Requisition for Additional Packaging Material