To lay down a procedure for handling of Rejected Raw Material.
This SOP shall be applicable for handling of rejected raw material at Stores Department.
Officer/ Executive Stores
Head of Department
REJECTION OF RAW MATERIAL MAY BE DUE TO
• Material Reject due to received in damaged condition.
• Material Reject during testing by Q.C. dept.
• Online Rejection.
• Material Reject during retesting.
• Approved Material Expired during storage.
5.1 Material reject due to received in damaged condition
5.1.1 At the time of receipt, if material is received in damaged condition, Store person shall inform HOD-QA & QC.
5.1.2 If material is rejected by Q.A. department after inspection, Store person shall transfer the material in rejected room under lock & key and fill the material discrepancy report and inform to Purchase department.
5.1.3 After getting instruction from purchase department, prepare the Delivery Challan with excise document and sent to supplier thorough transporter.
5.1.4 If Purchase department instruct to destroy the material at 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-Production, HOD-Store and Unit Head before destroying the material.
5.1.7 After approval, store person shall transfer the material from the rejected area and send it to ETP for destruction.
5.1.8 The material shall be destroyed in presence of Quality Assurance, Stores and Security person.
5.1.9 Store person shall send copy of destruction note to Purchase Dept. for raising debit note.
5.1.10 Store person shall debit the entries of the rejected material in the SAP system, excise register and bin cards rejected.
5.2 Material reject during testing by Q.C. department
5.2.1 If 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 After getting instruction from purchase department, prepare the delivery challan with excise document if required and sent to supplier thorough transporter.
5.2.3 If Purchase department instruct to destroy the material at site, store person shall destroy it as per point no 5.1.5 to 5.1.10
5.2.4 Store person shall send one 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 Head- QA & QC for necessary action.
5.3.2 Store person shall transfer the material in rejected room under lock & key & debit the quantity rejected in SAP and make a material rejection report.
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 material is to be sent back to the supplier, follow the step 5.2.2
5.3.5 If material is destroyed in factory premises, follow the step from 5.1.5 to 5.1.10
5.4 Material reject during retesting
5.4.1 If 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 material is destroyed in factory premises, follow the step from 5.1.5 to 5.1.10
5.5 Approved material expired during storage
5.5.1 Every 1st week of the month, Store person shall generate the list of raw materials which are going to expire in next 60 days from SAP system.
5.5.2 Store person shall intimate to Quality assurance Department by giving one copy of the list of raw materials which are going to be expired.
5.5.3 QA person shall rejects the raw material after completion of the expiry date and affixes rejected status label on the container after consultation with QC Department.
5.5.4 The material should be destroyed in the factory premises.
5.5.5 Store person shall prepare the destruction note for the same and follow the step from 5.1.5 to 5.1.10
6.1 SOP – Standard operating procedure
6.2 QA – Quality assurance
6.3 QC – Quality control
6.4 HOD – Head of department
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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