Table of Contents
1.0 OBJECTIVE of Reprocessing and Reworking of Product
1.1 To lay down the procedure for Reprocessing and Reworking of Product.
2.0 SCOPE:
2.1 This SOP is applicable for Reprocessing and Reworking of product nonconforming products in production department.
3.0 RESPONSIBILITY
3.1 Manager-production
4.0 ACCOUNTABILITY of Reprocessing and Reworking of Product
4.1 Head- Quality Assurance
5.0 PROCEDURE of Reprocessing and Reworking of Product
5.1 Reprocessing: It is subjecting an intermediate stage product or final product that does not conform to standards or specifications to one or more processing step that are part of established manufacturing process in order to obtain acceptable quality intermediate stage or final product.
5.2 Reworking: It is subjecting an intermediate stage product or final product that does not conform to standards or specifications to one or more processing step that are different from established manufacturing process in order to obtain acceptable quality intermediate stage or final product.
5.3 Reprocessing in case of Product Exported to Regulated Market.
5.3.1 No reprocessing shall be carried out for the export product without the permission of the qualified person / Contract Givers.
5.3.2 Approval of Qualified Person / Contract Giver shall not be taken for the following.
5.3.2.1 Reprocessing in case of online Blistering and Striping shall be carried out for defect in knurling, empty or cut pocket, forming of blister/ strip, leak test, vertical and horizontal cutting, overprinting of product details, etc.
5.3.2.2 Reprocessing in case of online cartooning shall be carried out for torn cartons, damaged carton and improper overprinting. Reconciliation of printed packing material shall be done and recorded in Batch packing record.
5.3.3 Non-conformances other then above shall be investigated and reprocessing shall be performed with prior review with consideration for potential risks and approval of Quality Control and Quality assurance.
5.3.4 Additional testing and stability of Finished Product shall be carried out if required.
5.4 Reprocessing in case of product manufactured for Domestic and other Export market.
5.4.1 Reprocessing in case of Mixing, Drying, Compression and Coating stages shall be handled according to SOP “Handling of Deviation”. The deviation shall be raised by Production Department and approved by Head-QA on review. On approval of deviation production shall intimate to Quality Assurance in writing the detail reprocessing procedure. The entire activity shall be carried out under supervision of production and Quality Assurance. Rejected material shall be destroyed in presence of IPQA. Reprocessing activity shall be recorded in Batch Manufacturing Records.
5.4.2 Non-conformances shall be investigated and reprocessing shall be performed with prior review with consideration for potential risks and approval of Quality Assurance.
5.4.3 Additional testing and stability of finished product shall be carried out if required.
5.4.4 Reprocessing in case of online Blistering and Striping shall be carried out for defect such as knurling, empty or cut pocket, forming of blister/ strip, leak testing, vertical and horizontal cutting, overprinting of product details. Reconciliation of Primary Packaging material shall be done and recorded in Batch Packing Record(BPR)
5.4.5 Reprocessing in case of online cartooning shall be carried out for torn cartons, damaged carton and improper overprinting. Reconciliation of printed packing material shall be done and recorded in Batch Packing Record.
5.4.6 Reprocessing in case of conversion of finished goods (export to sale, sale to export and sale to physician sample) shall be handled and deviation shall be raised by production department and approved by Head-QA on review. On approval of deviation, production shall raise the intimation for withdrawal of finished goods from Finished Goods Store. The entire activity shall be carried out under the supervision of Production and Quality Assurance. Deformed packing material shall be destroyed in presence of IPQA. Redressing activity shall be recorded in batch records.
5.5 Reworking in case of product Exported to Regulated Market.(Reprocessing and Reworking of Product)
5.5.1 No Reworking of a product Exported to the Regulated Market shall be taken up unless approval is obtained from the Qualified Person / Contract Giver and necessary specific batch variation approval is obtained from the relevant member of state Regulatory Authority / Contract Giver and it shall be handled according to SOP on “Handling of Deviation”.
5.5.2 Additional testing and stability of Finished Product shall be carried out if required.
5.6 Reworking in case of product manufactured for Domestic Market.
5.6.1 Reworking in case of products manufactured for domestic market shall not be taken without obtaining prior approval from Head- QA and it shall be handled according to SOP on “Handling of Deviation”.
5.6.2 Non-conformances shall be investigated and reworking shall be performed with prior review with consideration for potential risks and approval of Quality Control, and Head-QA.
5.6.3 Additional testing and stability of Finished Product shall be carried out if required.