SOP Guide for Pharma

SOP for Receiving and Handling of Controlled Substances in Raw Material Stores – V 2.0

Auditor

SOP for Receiving and Handling of Controlled Substances in Raw Material Stores – V 2.0

Standard Operating Procedure for Receiving and Handling of Controlled Substances in Raw Material Stores

Department Warehouse / Quality Assurance / Security
SOP No. SOP/RM/014/2025
Supersedes SOP/RM/014/2022
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) outlines a comprehensive method for the receipt and handling of controlled substances within the raw material stores. Controlled substances require stringent security measures, documentation, and regulatory compliance to prevent misuse, theft, or unauthorized access. By adhering to this SOP, the organization ensures compliance with national and international regulations governing controlled substances, upholds Good Manufacturing Practice (GMP) requirements, and maintains accurate records for audit readiness. Additionally, this SOP provides guidelines for safeguarding materials from contamination or mix-ups and implementing secure storage conditions that maintain product integrity.

2. Scope

This SOP applies to all controlled substances delivered to the facility’s receiving dock or designated receiving area for raw materials. It includes:

All personnel involved in the receipt, inspection, and storage of controlled substances—especially those requiring security clearance or specialized training—must follow these procedures. Procurement, QA, and Security must ensure that controlled substances are received, handled, and documented according to this SOP and all applicable regulations (e.g., DEA, local drug enforcement agencies).

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for the safe receipt and immediate handling of controlled substances. The QA Manager is responsible for ensuring compliance with GMP and regulatory mandates, while the Security Department oversees physical security measures. Final authority regarding acceptance or rejection of a shipment resides with QA. Any revisions to this SOP must be reviewed and approved by QA Management and, if required, the Security Department or relevant legal/regulatory affairs to remain consistent with updated regulations.

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5. Procedure

5.1 Pre-Receipt Preparations

Before a controlled substance shipment arrives, Warehouse Personnel, QA, and Security must coordinate to ensure readiness. This includes reviewing permits, checking storage availability, and confirming that only authorized staff will manage the receipt.

  1. Documentation and Licensing Verification
    1. Procurement or the Regulatory Affairs department should provide any required import/export licenses, DEA Forms (if applicable), or other certifications prior to shipment arrival. Check validity and expiry dates of these licenses.
    2. Ensure that the Purchase Order (PO) references the correct license number and that the supplier is approved to ship controlled substances to the facility.
  2. Secure Area Preparation
    1. Confirm the controlled substance vault or cage is ready to receive new stock. Verify that environmental conditions (temperature, humidity) meet any requirements outlined in the substance’s Safety Data Sheet (SDS) or product specifications.
    2. Check that security systems (cameras, alarms) and access logs are fully functional and up to date.
  3. Personnel Authorization
    1. Compile a list of staff authorized to receive, handle, or escort the shipment. Typically, this includes Warehouse Personnel, a QA representative, and a Security representative.
    2. Provide all authorized personnel with any special personal protective equipment (PPE) or ID badges required for the handling of controlled substances.

5.2 Receiving the Shipment

Upon arrival of the transport vehicle, specific protocols must be followed to maintain security and document the handover of controlled substances.

  1. Delivery Vehicle Inspection
    1. Warehouse Personnel, accompanied by Security if necessary, inspect the exterior of the truck or van for signs of tampering or seal breaches. Compare the seal number with the shipping documentation if provided.
    2. If any sign of tampering is noted, escalate to QA and Security. Do not proceed with unloading until an investigation or verification is completed.
  2. Matching Shipment Documents
    1. Verify that the Bill of Lading, packing list, and any other transport paperwork match the PO details: substance name, quantity, and batch or lot numbers. Ensure the controlled substance classification is noted on the documents.
    2. Check for additional documentation required by local or federal law, such as a DEA Form 222 (in the US) or equivalent. If missing, contact Regulatory Affairs or QA for guidance.
  3. Initial Quantity Check
    1. Count the number of containers (boxes, drums, sealed bags, etc.) listed on the packing list. If the actual count differs, note the discrepancy in the Raw Material Receiving Register (Annexure-1) and alert Procurement and QA immediately.
    2. Keep the containers sealed or intact for further inspection within a secure environment. Do not open them at the loading dock unless explicitly instructed by QA or necessary for immediate verification.

5.3 Transfer to Secure Storage

Controlled substances must be promptly transferred to the designated secure area under supervision to prevent unauthorized access or diversion.

  1. Escort Procedure
    1. An authorized Warehouse Personnel member and a Security representative escort the shipment from the receiving dock to the controlled substance vault or cage. Only authorized personnel may handle or accompany the materials.
    2. Maintain continuous observation of the shipment. Avoid leaving the controlled substances unattended at any time during transport within the facility.
  2. Entry Log and Inventory Update
    1. Upon arrival at the secure storage area, sign in the shipment using the Controlled Substance Inventory Log (a dedicated logbook or electronic system). This log should capture the date, time, substance name, quantity, batch/lot number, and the signatures of the personnel transferring the materials.
    2. Update the electronic or manual Warehouse Management System (WMS) to reflect the new stock. Link the record to the PO number and any specific license data, ensuring full traceability.
  3. Vault/Cage Placement
    1. Store the containers in the predetermined location within the vault or cage, following any environmental requirements (e.g., temperature-controlled cabinets) and organizational guidelines on segregation (e.g., separate shelves for different schedules of controlled substances).
    2. Securely lock the area once the materials are placed. If the vault or cage uses biometric access, ensure the door logs the entry and exit times. Keep the keys or access cards restricted to authorized personnel only.
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5.4 Inspection and Documentation

After the materials are safely in the secure area, QA and Warehouse Personnel must verify label details, batch numbers, and overall compliance. This step ensures that the shipment is correctly identified and legally documented.

  1. Label and Certificate of Analysis (CoA) Check
    1. With QA oversight, confirm that the label on each container matches the Purchase Order details, including substance name, batch/lot number, and quantity. Check for expiration or retest dates if applicable.
    2. Review any provided CoA or regulatory certificates. If the documentation indicates the substance is from a licensed source, ensure the batch number aligns with the label. Any mismatch or missing data should prompt a quarantine status until resolved.
  2. Security and QA Validation
    1. Both QA and Security representatives may initial or sign off in the Controlled Substance Inventory Log or the Raw Material Receiving Register (Annexure-1) to confirm that all items are accounted for and properly labeled.
    2. If the physical check reveals damage, tampering, or labeling errors, place the affected containers in a designated “Hold” area within the secure storage room. Notify Procurement for potential supplier issues and initiate a deviation if needed.
  3. Completed Records
    1. Attach or file all relevant paperwork (packing list, CoA, license copies) in the controlled substance documentation file. For electronic systems, upload scanned versions and link them to the inventory record.
    2. Ensure that a final entry is made in the Raw Material Receiving Register, referencing the controlled substance log or vault records. This cross-reference enables easy audits and ensures consistent traceability.

5.5 Handling Discrepancies and Deviations

Even minor discrepancies in quantity, labeling, or licensing can trigger regulatory scrutiny. Any issues must be addressed swiftly and thoroughly.

  1. Quantity Shortages or Overages
    1. If the quantity of the controlled substance does not match the PO or the transport documents, record the actual amount in the inventory log and label it as a discrepancy. Contact Procurement and QA to investigate further.
    2. Shortages may require immediate reporting to relevant regulatory agencies if mandated by law. Overages, similarly, must be clarified—either the supplier shipped extra by mistake, or there may be an error or potential diversion risk that requires full documentation.
  2. Label or Document Inconsistencies
    1. If the label does not match the CoA or licensing data, quarantine the shipment. QA must either confirm the correct details via supplier communication or decide on rejection if authenticity cannot be established.
    2. Security should monitor the quarantined materials closely until the discrepancy is resolved, maintaining chain-of-custody logs.
  3. Deviation and CAPA Process
    1. Major discrepancies or repeated issues require a formal deviation report. QA leads an investigation into how the discrepancy occurred, the potential impact on product integrity, and whether a CAPA is necessary to prevent recurrence.
    2. Procurement or Regulatory Affairs may engage the supplier to update packaging procedures, improve labeling, or revise shipping methods. The supplier’s performance might be re-evaluated for continued approval as a controlled substance source.
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5.6 Final Release or Rejection

Depending on the inspection outcomes, QA releases the controlled substance for further use or rejects it. Secure handling remains paramount in both scenarios.

  1. QA Authorization
    1. After verifying all documentation, quantity, and physical condition, QA signs off to release the shipment for approved usage (e.g., manufacturing, lab usage). The Warehouse Manager updates the final inventory status in the controlled substance log or WMS.
    2. If QA identifies significant issues that cannot be resolved or that breach regulatory guidelines, they may reject the shipment. Rejected items remain in the secure vault or cage but are clearly labeled as “Rejected,” segregated from approved stock.
  2. Return or Disposal
    1. In the case of rejection, Procurement and QA collaborate with the supplier on return-to-vendor arrangements or disposal according to legal requirements. Security oversees the disposal process to ensure no diversion occurs.
    2. Maintain a disposal record or certificate if local regulations mandate it. Attach all relevant documentation to the batch file for audit readiness.
  3. Archiving and Storage
    1. Keep all physical and electronic records (receiving logs, controlled substance inventory logs, CoAs, deviation reports) accessible for the retention period stipulated by regulatory agencies. Only authorized personnel should have access to these records.
    2. Ensure data integrity practices (e.g., date/time stamps, version control, secure backups) if an electronic system is employed. Regularly audit the log to confirm that no unauthorized edits have been made.

6. Abbreviations

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Controlled Substance Inventory Log (Vault/Cage Logbook)
  3. Sampling Log (Annexure-2) (If sampling is needed)
  4. Delivery Documents (Bill of Lading, Licenses, Permits, etc.)
  5. Certificates of Analysis (CoAs) and SDS
  6. Deviation/Non-Conformance Reports (if applicable)

8. References

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 Received Remarks
01/02/2025 Controlled Supply Co. API-CS1 CS-Batch-001 PO-12345 50 kg No Discrepancy
02/02/2025 Secure Pharm Ltd. API-CS2 CS-Batch-002 PO-67890 20 kg Seal Tampered

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 API-CS1 CS-Batch-001 John Doe Identity, Potency Pass
03/02/2025 API-CS2 CS-Batch-002 Jane Smith Identification Pending

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 SOP for controlled substance receiving
01/02/2025 2.0 Updated Security Procedures Standardization of Document QA Head All All Expanded guidelines for licensing checks and vault documentation
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