Standard Operating Procedure for Handling Suspected Counterfeit or Adulterated Raw Materials

Department	Warehouse / Quality Assurance / Quality Control / Security
SOP No.	SOP/RM/021/2025
Supersedes	SOP/RM/021/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) establishes a clear method for identifying and managing raw materials suspected of being counterfeit or adulterated. Counterfeit and adulterated materials pose serious threats to product quality, patient safety, and regulatory compliance. By implementing this SOP, the organization ensures:

• A consistent, systematic approach to detect, quarantine, and investigate questionable raw materials.
• Proper documentation and communication with key stakeholders (Quality Assurance, Warehouse, Procurement, and possibly legal/regulatory authorities) if suspect materials are discovered.
• Minimized risk of incorporating substandard or harmful components into production, thereby safeguarding end users and preserving company reputation.

The procedures outlined here support Good Manufacturing Practice (GMP) and regulatory requirements by ensuring thorough investigation and traceability for suspicious raw materials. This SOP ultimately helps protect consumers, maintain compliance, and enforce high-quality standards across the supply chain.

2. Scope

This SOP applies to all raw materials received at the facility’s warehouse or designated receiving areas. It includes:

• Initial inspections at receipt (label checks, packaging integrity, documentation verification).
• Criteria for designating a raw material as “suspected counterfeit” or “suspected adulterated.”
• Procedures for quarantining, sampling, testing, and final disposition (release or rejection) of questionable materials.
• Communication with relevant departments (Warehouse, Quality Assurance, Quality Control, Procurement, and Security) for investigating the source and extent of potential counterfeiting or adulteration.

All Warehouse Personnel, Quality Assurance (QA), Quality Control (QC), Procurement staff, and Security personnel must follow these guidelines whenever raw materials appear to be inconsistent with expected specifications or suspected of being substandard, tampered with, or illegally produced.

3. Responsibilities

• Warehouse Personnel:
  • Conduct routine inspections and note any anomalies (e.g., unusual label format, missing seals, signs of tampering).
  • Notify QA immediately if a raw material does not match the expected label, batch number, or packaging conditions, or if the labeling appears irregular or counterfeit.
  • Segregate and quarantine suspect materials to prevent inadvertent use until QA approves further actions.
  • Document all findings in the Raw Material Receiving Register and coordinate with QC for sampling if required.
• Quality Assurance (QA) Team:
  • Define acceptance criteria and red flags indicating potential counterfeiting or adulteration.
  • Review and approve or reject suspicious materials once an investigation or advanced testing is completed.
  • Lead any deviation or non-conformance reports related to suspected or confirmed counterfeit/adulterated raw materials.
  • Coordinate with legal/regulatory authorities if mandated by local laws or if a widespread risk is identified.
• Quality Control (QC) Team:
  • Perform targeted testing on suspect materials (identity checks, advanced chemical or microbial analyses) to detect adulterants or confirm authenticity.
  • Collaborate with QA on interpreting test results and deciding whether the material can be salvaged, re-tested, or must be rejected.
• Procurement Department:
  • Source raw materials only from approved, reputable suppliers listed on the Approved Vendor List (AVL).
  • Address repeated incidents of suspicious materials by liaising with suppliers or removing them from the AVL if non-compliance is proven.
  • Communicate all relevant purchase details (batch, supplier, shipping methods) and regulatory requirements to the Warehouse and QA teams.
• Security Department (If Applicable):
  • Assist QA in investigating potential counterfeiting or theft that might indicate supply chain breaches or malicious adulteration.
  • Secure quarantined materials to ensure no unauthorized access during the investigation.

4. Accountability

The Warehouse Manager is responsible for ensuring that all incoming raw materials suspected of being counterfeit or adulterated are promptly identified, quarantined, and reported to QA. The QA Manager holds ultimate authority over accepting or rejecting any suspicious items and must review any relevant test results or supplier explanations. Any SOP updates must be reviewed and approved by QA Management to comply with evolving GMP and regulatory standards.

5. Procedure

5.1 Identifying Suspected Counterfeit or Adulterated Materials

Suspicion may arise from label discrepancies, unusual packaging quality, missing documentation, or unexpected test results. Early detection reduces the risk of contamination or usage in production.

1. Initial Receipt Checks
   1. Warehouse Personnel perform a routine visual inspection as materials arrive, cross-checking label details (product name, batch number, manufacturer, expiration date) against the Purchase Order (PO) and standard label examples.
      • A label with blurred text, inconsistent logo, or missing batch data can signal counterfeit packaging.
      • Poor sealing or damaged tamper-evident seals can suggest adulteration or unauthorized access.
   2. Match the actual quantity with the PO and supplier documents. Significant discrepancies in quantity may be a red flag, especially if the invoice states a correct amount but the shipped containers are fewer or differ in net weight.
2. Documentation Verification
   1. Review the Certificate of Analysis (CoA) or supplier quality certificate. Confirm it references the correct batch, date, and test parameters. Inauthentic CoAs often have generic test data that fails to match the batch label or does not align with expected material specifications.
   2. Check that shipping documents, including the bill of lading, invoice, and packing list, align with the supplier’s known details. Fake or misspelled supplier addresses, altered logos, or suspicious stamps might indicate fraudulent origins.
3. Supplier History
   1. Consider the supplier’s track record. If the entity is newly added or has a history of prior quality infractions, exercise heightened vigilance. QA or Procurement might provide watchlist data or special instructions for high-risk suppliers.
   2. Suppliers not on the Approved Vendor List (AVL) or lacking contract documentation are immediate red flags. Procurement must confirm their legitimacy before the Warehouse accepts shipments.
4. Physical State and Packaging Quality
   1. Check the packaging materials (drums, bags, boxes) for suspicious prints or color variations. A container bearing incomplete or misaligned brand markings might be counterfeit.
      • Excessively flimsy packaging for a product usually shipped in rigid, tamper-evident containers may indicate a switch by counterfeiters.
   2. Look for leaking, discolored, or pungent-smelling contents that deviate significantly from the expected color, consistency, or odor for the material. Such anomalies often indicate adulteration or substandard purity.

5.2 Quarantine and Initial Notification

Any raw material that raises suspicion must be quarantined and isolated from approved stock to prevent accidental use or mixing.

1. Labeling and Segregation
   1. Warehouse Personnel attach a “Suspected Counterfeit or Adulterated” label to each questionable container, specifying the date of receipt, batch number, and reason for suspicion (e.g., tampered seal, incorrect label, questionable CoA).
   2. Move these items to a designated “Hold” or quarantine area with restricted access. Record the location in the Raw Material Receiving Register (Annexure-1) and any electronic inventory system.
2. Notify QA and Procurement
   1. Warehouse staff promptly inform QA about the quarantined materials, providing photo evidence or sample anomalies if feasible. Procurement should be copied if supplier verification or additional shipping documents are needed.
   2. QA reviews the preliminary findings and instructs if additional measures—like sampling, advanced testing, or immediate rejection—are warranted.
3. Security Involvement (If Needed)
   1. If the suspect materials indicate potential supply chain infiltration (e.g., counterfeit brand-labeled packaging, or the product is a controlled or high-value substance), Security may assist QA in investigating possible theft or forging operations.
   2. All quarantined containers remain locked or sealed off to preclude unauthorized removal or tampering during the investigation.

5.3 Investigation and Testing

Confirming counterfeit or adulteration generally requires deeper inspection, supplier communication, and targeted QC analyses.

1. Supplier Communication
   1. Procurement contacts the supplier for official clarifications. This may involve:
      • Requesting an authentic CoA from the supplier’s QA department.
      • Verifying batch release records or shipping logs from the supplier’s end to ensure the batch is legitimate.
      • Asking for photographic evidence of how the packaging originally left the supplier’s facility, verifying label format or seal style.
   2. Document all supplier responses, emailing relevant details to QA. If the supplier denies knowledge or refuses to clarify, the suspicion of counterfeiting or adulteration intensifies.
2. QC Analysis
   1. QA may request QC to perform specific identity tests or advanced analyses (e.g., FTIR spectroscopy, HPLC for purity, micro testing) on suspect materials. Compare results to known reference standards or legitimate CoA data for that batch.
   2. If the tested sample falls outside of typical specifications or exhibits unusual profiles (e.g., unexpected peaks in chromatography, foreign particulate matter), adulteration or mislabeling is likely. Document all findings meticulously in the Sampling Log (Annexure-2) and relevant lab records.
3. Cross-Checking Supplier’s CoA
   1. Compare the CoA details (batch number, production date, specification range) with:
      • The suspect raw material’s label data.
      • QC test results from in-house analyses.
      • Any additional information gleaned from supplier or known reference standards.
   2. Major mismatches (e.g., CoA states 99% purity, but in-house testing shows 85%) imply adulteration or a counterfeit CoA. QA can escalate the matter to management or regulatory bodies if it’s a controlled or critical substance.

5.4 Decision and Disposition

Once QA and QC gather sufficient evidence, a final decision is made on whether the suspect raw material is genuine, acceptable, or must be rejected due to confirmed or likely counterfeiting or adulteration.

1. QA Review
   1. QA examines all test results, supplier clarifications, and photographic or documentary evidence. If everything aligns favorably, QA may authorize a release for standard QC testing (if not already done) or for direct usage if the material meets acceptance criteria.
   2. If the suspicion persists or tests confirm adulteration/counterfeiting, QA rejects the entire lot. Mark containers “Rejected—Counterfeit/Adulterated” and store them in a segregated, locked area to prevent unauthorized access or usage.
2. Procurement and Supplier Negotiation
   1. If the shipment is indeed counterfeit or adulterated, Procurement may demand a credit, replacement, or formal corrective action from the supplier. If the supplier is complicit or uncooperative, they may be removed from the AVL altogether.
   2. For severe cases or repeated infractions, legal or regulatory authorities (e.g., local FDA equivalents) might be notified, especially if patient safety or public health is at risk.
3. Disposal or Return of Rejected Materials
   1. Follow the facility’s hazardous or controlled material disposal SOP if the suspected materials pose risk. Document disposal or return-to-vendor details, including a chain-of-custody record, to ensure complete traceability.
   2. If the supplier requests the materials back, ensure they remain sealed and labeled “Suspected Counterfeit” or “Suspected Adulterated” to avoid any liability or confusion downstream. Maintain shipping records proving final disposition.

5.5 Documentation and Further Actions

Comprehensive record-keeping is essential for audits, regulatory compliance, and preventing future incidents of counterfeiting or adulteration.

1. Raw Material Receiving Register Completion
   1. Once QA decides acceptance or rejection, Warehouse Personnel update Annexure-1 with final status. Indicate “Approved after Investigation” or “Rejected—Counterfeit Confirmed.”
   2. Initial or sign each entry. If the organization uses a digital Warehouse Management System (WMS), finalize the record with user credentials and timestamps for traceability.
2. Deviation or Non-Conformance Closure
   1. All events labeled as suspected counterfeit/adulteration should have a corresponding deviation or non-conformance report. QA includes final findings, root cause (if identified), and corrective actions.
      • If the cause is determined to be external supply chain infiltration, note that in the record and highlight any alerts needed for future deliveries from that route or vendor.
   2. Close out the record once the resolution steps are completed (e.g., disposal or vendor credit, regulatory notification) and QA confirms no outstanding tasks remain.
3. Regulatory and Legal Notifications
   1. For serious cases (large volumes of counterfeit materials or potential public health threats), the organization’s legal or regulatory affairs teams may file official reports with agencies such as the FDA, Interpol, or local authorities. QA and Procurement assist by providing all relevant documentation.
   2. Maintain copies of all communications, ensuring the incident is traceable for future audits or legal proceedings if necessary.
4. Supplier Performance Review and CAPA
   1. Procurement, QA, and management evaluate the supplier’s performance. If a once-reputable supplier inadvertently sourced counterfeit raw materials from a sub-tier, they may propose implementing stricter supply chain controls or bridging direct lines of communication.
   2. Serious or repeated occurrences result in removal from the AVL. Summarize the CAPA approach in a management review or supplier performance meeting.
      • Examples of CAPA might include:
        • Revising supplier qualification processes
        • Adding extra identity tests for incoming shipments from that supplier
        • Mandating new tamper-evident seals or advanced label technology (QR codes, holograms)

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• CoA: Certificate of Analysis
• AVL: Approved Vendor List
• CAPA: Corrective and Preventive Action
• WMS: Warehouse Management System
• FDA: Food and Drug Administration (or local equivalent)

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Purchase Orders, Supplier Invoices, and Shipping Documents
4. CoAs (if provided), Safety Data Sheets (SDS)
5. Deviation or Non-Conformance Reports
6. Supplier Correspondence (emails, phone logs, etc.)
7. QC Test Results and Investigation 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 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Company-Specific Procurement, QA, and Warehouse Policies
• Local Regulatory Guidelines or Anti-Counterfeiting Laws

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	Remarks
01/02/2025	ABC International	API-X	Lot 123	PO-56789	100 kg	Suspicious Label, QA Hold
02/02/2025	XYZ Chemical	Excipient Y	Batch 456	PO-98765	200 kg	No Discrepancy

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	API-X	Lot 123	John Doe	FTIR, Assay	Out of Spec	Possible Adulteration
02/02/2025	Excipient Y	Batch 456	Jane Smith	Identification	Pass	–

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	Establish procedure for suspect counterfeit/adulterated raw materials
01/02/2025	2.0	Refined Investigation Steps	Standardization of Document	QA Head	All	All	Enhanced testing guidelines, integrated security involvement, clarified final disposal/return procedures