SOP for Handling of Rejected Packing Materials : Pharmaceutical Guidelines

SOP for Handling of Rejected Packing Materials

Standard operating procedure to handle the rejected materials during QC analysis, online rejection or retesting.

1.0 OBJECTIVE

To lay down a procedure for handling of Rejected Packing Materials.

2.0 SCOPE

This SOP shall be applicable for the handling of rejected Packing Materials at Stores Department.

3.0 RESPONSIBILITY

Officer Stores/ Executive

4.0 ACCOUNTABILITY

Head of Stores

5.0 PROCEDURE

5.1 Material reject due to received in damaged condition

5.1.1 At the time of receipt, if the material is received in damaged condition, Store person shall inform HOD-QA & QC.
5.1.2 If the material is rejected by Q.A. department after inspection, Store person shall transfer the material in the rejected room under lock & key and fill the material discrepancy report and inform to Purchase department.
5.1.3 If Purchase department instructs to send the rejected material to supplier store person shall prepare the Delivery Challan & Excise Document if required & send the copy of Delivery Challan and Invoice to Purchase department for their documentation/debit note purpose.
5.1.4 If Purchase department instructed to destroy the material at the site, store person shall destroy it in consultation with QA department.
5.1.5 Store person shall enter the details of rejected material in the discrepancy cum rejection register.
5.1.6 Store person shall prepare the destruction note and get approval from the HOD-QA & QC, HOD- Store and Unit Head before destroying the material.
5.1.7 The material shall be destroyed in presence of Quality Assurance, Stores and Security person.
5.1.8 Store person shall send a copy of destruction note to Purchase Dept. for raising debit note.
5.1.9 Store person shall debit the entries of the rejected material in the SAP system, excise register and bin cards (Bin Card Rejected).

5.2 Material reject during testing by Q.C. department

5.2.1 If the material is rejected by Q.C. department during testing, store person shall ask rejection note from Q.C. department and send it to purchase department for information.
5.2.2 If Purchase department instructed to destroy the material at the site, store person shall destroy it as per point no 5.1.5 to 5.1.8
5.2.3 If Purchase department instructs to send the rejected material to supplier Store person shall prepare the Delivery Challan & Excise Document if required & send a copy of Delivery Challan and Invoice to Purchase department for their documentation/debit note purpose.

5.3 Online Rejection

5.3.1 At the time of dispensing or manufacturing process if Store, Production or Q.A. person found any discrepancy in material, production person shall fill the online rejection note and inform to HOD- QA & QC for necessary action.
5.3.2 Store person shall transfer the material to a rejected room under lock & key.
5.3.3 Store person shall inform to purchase dept. for rejection & wait for the decision whether the material is to be sent back to the supplier or destroyed in the factory premises.
5.3.4 If the material is destroyed in factory premises, follow the step from 5.1.5 to 5.1.9

5.4 Material reject during retesting

5.4.1 If the material is rejected by Q.C. department during retesting, store person shall ask for rejection note from Q.C. department & Send it to purchase department for information.
5.4.2 After getting instruction from purchase department, store person shall destroy the material in consultation with QA department.
5.4.3 If the material is destroyed in factory premises, follow the step from 5.1.5 to 5.1.9.
Note: All printed packing material will be destroyed at factory premises and will not sent back to the supplier.

6.0 ABBREVIATION

6.1 SOP - Standard Operating Procedure





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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