1.0 PURPOSE:
This procedure shall act as guideline to handle Reprocessing and Reworking of product at plant.
2.0 SCOPE:
This procedure shall be applicable to product manufactured at pharmaceutical plant. Reprocessing and Reworking of Non-Conforming product shall be carried out with reference to procedure given below.
3.0 RESPOSIBILITY:
3.1 Head of Corporate Quality Assurance
3.2 Head of Quality Assurance (Site)
4.0 DEFINATION:
4.1 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.
4.2 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.
5.0 PROCEDURE:
5.1 Reprocessing in case of Product Exported to Regulated Market
5.1.1 No reprocessing shall be carried out for Export Product without the permission of the Qualified Person / Contract Givers.
5.1.2 Approval of Qualified Person / Contract Giver shall not be taken for following.
5.1.2.1 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 testing, vertical and horizontal cutting, overprinting of product details, etc.
5.1.2.2 Reprocessing in case of online cartonating 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.
5.1.3 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, Quality assurance, Qualified Person / Contract Giver and if required R&D.
5.1.4 Additional testing and stability of Finished Product shall be carried out if required.
5.2 Reprocessing in case of product manufactured for Domestic and other Export market
5.2.1 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 Q.A Head 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.
5.2.2 Non-conformances shall be investigated and reprocessing shall be performed with prior review with consideration for potential risks and approval of Quality Control, Quality assurance and if required R&D.
5.2.3 Additional testing and stability of finished product shall be carried out if required.
5.2.4 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 Packing material shall be done and recorded in Batch Packing Record.
5.2.5 Reprocessing in case of online cartonating 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.
5.2.6 Reprocessing in case of conversion of finished good (export to sale, sale to export and sale to physician sample) shall be handled according to respective SOP. The deviation shall be raised by production department and approved by Q.A Head on review. On approval of deviation, production shall raise the intimation for withdrawal of finished good from Finished Good 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.
5.3 Reworking in case of product Exported to Regulated Market:
5.3.1 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”.
5.3.2 Additional testing and stability of Finished Product shall be carried out if required.
5.4 Reworking in case of product manufactured for Domestic Market:
5.4.1 Reworking in case of products manufactured for domestic market shall not be taken without obtaining prior approval from Corporate Quality Assurance and Corporate R&D and it shall be handled according to SOP on “Handling of Deviation”.
5.4.2 Non-conformances shall be investigated and reworking shall be performed with prior review with consideration for potential risks and approval of Quality Control, Quality Assurance, Corporate Quality Assurance and R&D.
5.4.3 Additional testing and stability of Finished Product shall be carried out if required.
6.0 REFERENCE
6.1 Handling of Deviation
7.0 ABBREVIATIONS
7.1 R & D : Research and Development
DOCUMENT CONTROL SHEET
| DOCUMENT HOLDERS
(Heads of the following departments) |
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DOCUMENT REVIEW STATUS SHEET
