processes. It includes:

• Visual inspection, documentation verification, and quality control testing of reprocessed materials.
• Criteria for acceptance, quarantine, or rejection based on inspection results.
• Responsibilities of warehouse, QA, QC, and procurement personnel in the handling and inspection of these materials.

3. Responsibilities

• Warehouse Personnel:
  • Receive and unload recycled or reprocessed raw materials, ensuring proper documentation accompanies each shipment.
  • Conduct preliminary visual inspections for packaging integrity, labeling accuracy, and obvious contamination risks.
  • Segregate and label materials appropriately, ensuring they are stored in designated quarantine areas pending QA review.
  • Record all relevant information in the Raw Material Receiving Register (Annexure-1).
• Quality Assurance (QA) Team:
  • Define acceptance criteria for recycled or reprocessed materials, ensuring alignment with GMP and regulatory standards.
  • Review documentation, including certificates of analysis (CoAs), reprocessing records, and batch histories.
  • Approve or reject materials based on inspection and QC testing outcomes.
  • Oversee deviations, non-conformances, and corrective actions related to recycled materials.
• Quality Control (QC) Team:
  • Conduct sampling and analytical testing to verify the identity, purity, and quality of recycled or reprocessed materials.
  • Document all test results and communicate findings to QA for final disposition decisions.
  • Investigate any anomalies or test failures, providing recommendations for re-testing or rejection.
• Procurement Department:
  • Ensure suppliers of recycled or reprocessed materials are approved and meet regulatory standards.
  • Verify that all shipments include proper documentation, including reprocessing certificates and traceability records.
  • Address supplier-related issues in cases of non-conformance, coordinating returns, replacements, or corrective actions.

4. Accountability

The Warehouse Manager is responsible for ensuring that all incoming recycled or reprocessed materials are inspected according to this SOP. The QA Manager has the authority to approve or reject materials based on inspection findings and QC test results. Any deviations from this SOP must be documented and approved by QA management to ensure compliance with GMP and regulatory requirements.

5. Procedure

5.1 Pre-Receipt Preparations

1. Documentation Review
   1. Procurement provides the warehouse with the purchase order (PO) and associated documentation, including reprocessing certificates, batch histories, and CoAs.
   2. Ensure all documentation specifies the origin of the recycled or reprocessed materials, reprocessing methods, and compliance with regulatory standards.
2. Inspection Area Readiness
   1. Prepare the designated receiving area to accommodate incoming recycled materials, ensuring segregation from other raw materials.
   2. Ensure all necessary inspection tools (e.g., magnifying glasses, protective gear) are available and in good working condition.
3. Training and Compliance
   1. Ensure warehouse and QA personnel are trained on the specific requirements for handling and inspecting recycled materials.
   2. Review regulatory guidelines relevant to recycled materials to ensure full compliance during the inspection process.

5.2 Receiving and Initial Inspection

1. Unloading Materials
   1. Unload recycled or reprocessed materials carefully, ensuring no additional damage occurs during handling.
   2. Verify that each shipment matches the PO details, including material name, batch number, and quantity.
2. Visual Inspection
   1. Inspect packaging for signs of damage, contamination, or tampering. Check for integrity of seals and labels.
   2. Examine the material for any visible anomalies such as discoloration, clumping, or unusual odors.
3. Label Verification
   1. Ensure labels include the following information:
      • Material name and description
      • Batch or lot number
      • Reprocessing date and methods used
      • Supplier name and contact information
      • Expiry or retest date, if applicable
   2. Flag any discrepancies in labeling for QA review.

5.3 Documentation and Segregation

1. Recording in Raw Material Receiving Register
   1. Enter all relevant details in the Raw Material Receiving Register (Annexure-1), including date of receipt, supplier information, batch number, and inspection findings.
   2. Document any observed issues or deviations in the remarks section of the register.
2. Segregation and Quarantine
   1. Label materials as “Awaiting QA Approval” and move them to the designated quarantine area.
   2. Ensure materials are stored under appropriate conditions (temperature, humidity) to prevent further degradation.

5.4 QA Review and QC Testing

1. QA Documentation Review
   1. QA reviews all accompanying documentation, including reprocessing certificates, batch histories, and CoAs.
   2. Verify that reprocessing methods comply with regulatory standards and that the material’s quality attributes are consistent with original specifications.
2. QC Sampling and Testing
   1. QC performs sampling according to the company’s Sampling SOP (Annexure-2) and tests the material for identity, purity, and contamination.
   2. Document test results and communicate findings to QA for final disposition.

5.5 Final Disposition

1. Acceptance
   1. If the material meets all specifications and passes QC testing, QA approves it for use and moves it to the approved storage area.
   2. Update the Raw Material Receiving Register to reflect the material’s approved status.
2. Rejection
   1. If the material fails to meet specifications or shows signs of contamination, QA rejects it and moves it to the designated rejection area.
   2. Document the reason for rejection in the Raw Material Receiving Register and initiate a non-conformance report.
3. Supplier Notification
   1. Procurement contacts the supplier to address any issues related to rejected materials, coordinating returns, replacements, or corrective actions as needed.
   2. Maintain records of all communications with the supplier regarding material quality and reprocessing standards.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• CoA: Certificate of Analysis
• CAPA: Corrective and Preventive Action

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Purchase Orders (PO), Supplier Invoices, Packing Lists
4. Certificates of Analysis (CoAs) and Reprocessing Certificates
5. Deviation/Non-Conformance Reports

8. References

• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• Company-Specific Procurement, QA, and Warehouse Policies

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Receiving Register

Date	Supplier Name	Material Name	Batch Number	PO Number	Quantity	Inspection Findings	Remarks
01/02/2025	ABC Chemicals	Reprocessed API-X	X-2025-R001	PO-12345	100 kg	Packaging Intact, No Visible Contamination	Sent for QA Review
02/02/2025	XYZ Pharma	Recycled Excipient-Y	Y-2025-R002	PO-67890	200 kg	Seal Damaged, Discoloration Observed	Quarantined, Awaiting QC Testing

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	Reprocessed API-X	X-2025-R001	John Doe	Identity, Purity	Pass	Approved for Use
03/02/2025	Recycled Excipient-Y	Y-2025-R002	Jane Smith	Microbial Test	Fail	Rejected Due to Contamination

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head	All	All	Established procedures for inspecting recycled and reprocessed raw materials.
01/02/2025	2.0	Expanded Inspection Criteria	Standardization of Document	QA Head	All	All	Added detailed guidelines for QC testing and supplier communication.