Quality Assurance (QA) evaluation. Examples include:

• Incorrect materials or batch numbers that do not match the Purchase Order.
• Damaged or tampered packaging (torn bags, leaking drums, etc.).
• Contaminated, adulterated, or substandard material as indicated by test results or visual inspection.
• Materials lacking essential documentation or labeling (e.g., missing batch number, expired CoA).

All Warehouse staff, QA, QC, Procurement, and any personnel involved in material handling or supplier communication must observe these protocols whenever a raw material is rejected.

3. Responsibilities

• Warehouse Personnel:
  • Identify materials failing to meet acceptance criteria during unloading or initial inspection.
  • Isolate and label rejected materials, recording necessary details in the Raw Material Receiving Register (Annexure-1).
  • Prevent rejected materials from mixing with standard inventory, ensuring they remain securely segregated until final disposition.
  • Communicate all rejection incidents to QA and Procurement promptly.
• Quality Assurance (QA) Team:
  • Approve or confirm the rejection of materials flagged by Warehouse or QC based on GMP requirements, testing results, or labeling anomalies.
  • Oversee any deviation or non-conformance reports arising from repeated or major rejection events.
  • Specify final disposal, return-to-vendor, or rework instructions, if applicable.
• Quality Control (QC) Team:
  • Perform or evaluate test results (assay, impurity profile, microbial count) if the rejection is based on suspected adulteration or test failures.
  • Communicate findings to QA and Warehouse for final acceptance or rejection decisions.
• Procurement Department:
  • Address issues with the supplier regarding rejections, seeking replacement materials, credits, or refunds.
  • Handle ongoing vendor performance monitoring, especially if repeated rejections persist.
  • Update the Approved Vendor List (AVL) if repeated or critical issues lead to supplier disqualification.

4. Accountability

The Warehouse Manager ensures that all rejected materials are properly identified, isolated, and documented. The QA Manager has final authority on rejection decisions, disposal methods, and any corrective actions or vendor follow-ups. Procurement and Warehouse coordinate with the supplier or vendor for replacements or refunds when appropriate. Any changes to this SOP must be reviewed and approved by QA management to uphold regulatory and quality standards.

5. Procedure

5.1 Initial Inspection and Rejection Trigger

During unloading or routine checks, Warehouse Personnel or QC staff may identify conditions that lead to raw material rejection.

1. Unloading and Basic Inspection
   1. When materials arrive, Warehouse Personnel visually examine the packaging, labels, and container seals. They compare delivered items to the Purchase Order (PO) for correct product name, batch number, quantity, and manufacturer.
   2. Any obvious deviations (e.g., unlabeled container, missing or mismatched batch number, severely damaged bags or drums) warrant immediate isolation. Label such containers “Hold—Awaiting QA Decision” or “Suspect—Damaged Packaging.”
   3. Record preliminary findings (e.g., torn outer bag, suspicious odor, or incomplete labeling) in the Raw Material Receiving Register (Annexure-1).
2. QC or QA Indication
   1. If the Warehouse’s initial checks pass but advanced testing or QA review later uncovers non-conformance (e.g., failed assay, contamination) the batch is then flagged for rejection. Mark all related containers accordingly.
   2. QA issues a “Rejection” decision if the raw material fails essential GMP criteria or shows test results outside approved specifications. QC tests can confirm or discover these issues post-inspection if sampling is performed.
3. Supplier Documentation Errors
   1. Major labeling or CoA documentation inconsistencies, such as mismatched batch numbers, questionable authenticity of CoA, or no valid expiry date can prompt rejection. QA may require additional info from Procurement or direct supplier contact to resolve if there’s a chance to salvage the shipment.
   2. If the supplier fails to provide acceptable clarifications or corrected documentation within a specified timeframe, QA proceeds with rejection to prevent indefinite storage of suspect goods in quarantine.

5.2 Isolation and Labeling of Rejected Materials

Once identified as rejected, the raw material must be physically separated from approved inventory to avoid mix-ups or accidental use in production.

1. Separation from Standard Stock
   1. Move rejected items to a clearly labeled “Rejected Area” or a secure quarantine cage if available. This area should be distinct from quarantined items pending approval, so no confusion arises about their status.
   2. Ensure Warehouse staff understand that rejected goods are off-limits, with restricted access to keys or code locks if dealing with hazardous or controlled substances.
2. Rejected Label Application
   1. Affix a red “Rejected” or “Not Approved” label on each container, referencing:
      • Batch/lot number
      • PO number
      • Date of rejection
      • Reason or short code (e.g., “Damaged Packaging,” “Failed QC,” “Mismatch with PO”)
   2. Document the label details in the Raw Material Receiving Register and/or WMS to maintain traceability. Indicate the label color or code to ensure all staff can visually identify the item’s status.

5.3 QA Review and Disposition Decision

QA, in collaboration with QC (if needed), determines the final fate of rejected materials, ranging from re-labeling or partial acceptance to disposal or return to vendor.

1. Documentation and Investigation
   1. QA reviews the receiving log entries, supplier CoA, and any QC test results. If the rejection reason is ambiguous or potentially fixable (e.g., labeling missing a minor detail), QA decides if re-labeling or minor corrective action can salvage the batch.
   2. In cases of suspected adulteration or severe damage, QA confirms the lot’s permanent rejection. For repeated or serious supplier errors, QA may open a deviation or non-conformance record.
2. Supplier Consultation (If Applicable)
   1. Procurement might request additional info from the supplier if the rejection is due to incomplete or incorrect docs. If the supplier can promptly rectify the issues, QA may hold the shipment in quarantine temporarily rather than finalizing rejection.
   2. If no adequate resolution emerges (e.g., suspect CoA authenticity, significant product discrepancy), QA’s rejection stands to maintain GMP compliance.
3. Final Disposition
   1. Return to Vendor (RTV): If the supplier agrees to accept the item back, Procurement arranges the logistics. Warehouse updates records, marking the shipment “Return to Vendor” and logs the date/time of removal from the facility.
   2. Disposal: If no return arrangement is feasible or the material is hazardous, QA instructs disposal per hazardous waste or local regulations. The Warehouse coordinates with EHS or specialized disposal companies, documenting chain-of-custody.
   3. Rework or Re-Labeling: In rare cases where QA sees an option to salvage the material (e.g., misprint on label but correct CoA, or minor re-packaging needed), QA issues rework instructions. All reworked materials remain quarantined until final QA approval.

5.4 Record-Keeping and Reporting

Comprehensive records confirm the organization’s adherence to GMP by ensuring traceability of rejected materials. They also facilitate potential supplier audits, CAPA, and documentation for financial or regulatory inquiries.

1. Raw Material Receiving Register Updates
   1. Warehouse Personnel finalize the remarks column for each rejected item, specifying “Rejected” or “Returned to Supplier.” If the final action is disposal, indicate the disposal date and method per disposal SOP references.
   2. Sign or initial the entry to affirm the accuracy of the rejection data. If using an electronic system (WMS/ERP), finalize the digital record, ensuring user credentials log the updates for audit trails.
2. Deviation or Non-Conformance Handling
   1. Should the rejection indicate systemic issues (e.g., repeated mislabeled lots from a particular supplier), QA or Warehouse opens a deviation record. Summaries of the issue, root causes, and recommended corrective actions are documented.
   2. Procurement helps QA track supplier responses or potential CAPA requirements to rectify repeated shipping/labeling problems. Closing the deviation requires verifying the problem is fully resolved for future deliveries.
3. Supplier Communication and Credits
   1. Procurement liaises with the supplier on credit issuance, replacements, or refunds. Attach or reference all relevant receiving records, pictures, or QA confirmations in the communications. Keep copies for internal records if future disputes arise.
   2. In the event of a major or hazardous rejection, the supplier’s performance or AVL status might be revisited at QA or management’s request. Document any escalations or changes in supplier status for future referencing.

5.5 Special Considerations

Certain raw material types or regulatory classifications may require additional steps beyond standard rejection protocols.

1. Hazardous or Controlled Materials
   1. If the rejected item is a controlled substance or a hazardous chemical, adhere to local legal requirements or DEA-like regulations for disposal or return. Ensure locked or secure storage until final removal from the site.
   2. Keep thorough chain-of-custody records. Involve Security or EHS if spillage or safety risks exist.
2. Temperature-Sensitive Substances
   1. Rejected materials requiring cold chain or specific temperature control must remain in proper conditions until final disposal or return. Mark them clearly as “Rejected—Temperature-Sensitive” to avoid accidental reintroduction into valid cold storage stock.
   2. If the temperature log or shipping data indicates a breach, QA might reject the item to prevent compromised biological or chemical quality. Document the final disposal or return path with temperature logs attached.
3. Suspected Counterfeit or Adulterated Products
   1. For suspect counterfeit or adulteration, follow the dedicated “Counterfeit/Adulterated” SOP if the organization has one. Typically, QA, Procurement, and Security collaborate to investigate potential supply chain infiltration or tampering before finalizing rejection.
   2. Regulatory or legal notifications may be mandatory, depending on local guidelines and the severity of the adulteration or potential health threat.

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
• AVL: Approved Vendor List
• EHS: Environment, Health, and Safety
• WMS: Warehouse Management System
• ERP: Enterprise Resource Planning

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Deviation / Non-Conformance Reports (if applicable)
3. Purchase Orders (PO), Supplier Invoices, CoAs
4. Company-Specific Hazardous Disposal and Security Logs (for controlled substances)
5. Security or EHS Incident Reports (if spillage or public safety concerns arise)

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 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Company-Specific QA, Procurement, 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	Rejection Reason	Remarks
01/02/2025	ABC International	API-X	X-2025-001	PO-111111	100 kg	Damaged Packaging	Leaking Drum, QA Notified
02/02/2025	XYZ Suppliers	Excipient-Y	Y-2025-005	PO-222222	200 kg	Label Mismatch	Wrong Batch on CoA, Rejected

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 procedure for rejecting non-conforming raw materials
01/02/2025	2.0	Enhanced Procedures	Standardization of Document	QA Head	All	All	Included more detailed labeling of rejected materials, final disposition, and supplier communication guidelines