SOP for Inspection and Receiving of Highly Potent Raw Materials – V 2.0

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SOP for Inspection and Receiving of Highly Potent Raw Materials – V 2.0

Standard Operating Procedure for Inspection and Receiving of Highly Potent Raw Materials

Department Warehouse / Quality Assurance / Quality Control / Procurement
SOP No. SOP/RM/033/2025
Supersedes SOP/RM/033/2022
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 the guidelines for the safe receipt, inspection, and handling of Highly Potent Raw Materials (HPRMs) at the facility. HPRMs, due to their toxicological properties, require specialized handling procedures to protect personnel, maintain material integrity, and comply with Good Manufacturing Practices (GMP) and regulatory standards. This SOP ensures:

  • Safe handling, storage, and inspection of HPRMs to minimize exposure risks to personnel and the environment.
  • Compliance with occupational health and safety (OHS) regulations and GMP guidelines.
  • Proper documentation and traceability of received HPRMs, including segregation and labeling.
  • Effective communication with suppliers and internal teams for handling deviations or incidents.

2. Scope

This SOP applies to all Highly Potent Raw Materials received at the facility, including Active Pharmaceutical Ingredients (APIs), intermediates, excipients, and other chemical substances classified as hazardous or toxic. It covers:

  • Receipt, unloading, and inspection procedures for HPRMs.
  • Personal Protective Equipment (PPE) requirements and safety measures.
  • Documentation, quarantine, and segregation processes for HPRMs.
  • Responsibilities of Warehouse, Quality Assurance (QA), Quality Control (QC), and Procurement teams in handling HPRMs.

3. Responsibilities

  • Warehouse Personnel:

    • Ensure proper unloading and initial inspection of HPRMs using appropriate PPE and safety protocols.
    • Segregate HPRMs in designated quarantine areas and label them appropriately.
    • Record all inspection details in the Raw Material Receiving Register (Annexure-1).
    • Report any damage, spillage, or deviations immediately to QA.
  • Quality Assurance (QA) Team:

    • Establish acceptance criteria and safety protocols for receiving HPRMs.
    • Review inspection findings, approve or reject materials, and oversee deviation management.
    • Ensure compliance with GMP, OHS, and regulatory standards for handling HPRMs.
  • Quality Control (QC) Team:

    • Perform sampling and analytical testing of HPRMs as per established procedures.
    • Ensure that appropriate containment and safety measures are in place during testing.
    • Report test results to QA for final disposition decisions.
  • Procurement Department:

    • Ensure that suppliers comply with shipping, labeling, and documentation requirements for HPRMs.
    • Coordinate with suppliers in case of discrepancies, damage, or non-compliance with safety standards.
See also  SOP for Physical and Visual Inspection of Incoming Raw Materials - V 2.0

4. Accountability

The Warehouse Manager is responsible for ensuring the safe receipt and inspection of Highly Potent Raw Materials as per this SOP. The QA Manager holds the authority to approve, quarantine, or reject materials based on inspection and QC testing outcomes. Any deviations from this SOP must be documented and approved by QA to ensure compliance with GMP and OHS regulations.

5. Procedure

5.1 Pre-Receipt Preparations

  1. Review of Purchase Orders and Safety Documentation

    1. Procurement provides the warehouse with the purchase order (PO), Material Safety Data Sheets (MSDS), and shipping documentation for the HPRMs.
    2. Verify that the supplier has provided the required documentation, including hazard classifications, PPE requirements, and emergency response procedures.
  2. Preparation of Inspection Area and Equipment

    1. Prepare a designated receiving area with proper containment measures, such as spill kits, fume hoods, and safety showers.
    2. Ensure that appropriate PPE (e.g., gloves, face shields, respirators, protective suits) is available for personnel handling HPRMs.
  3. Training and Safety Briefing for Personnel

    1. Ensure that all warehouse, QA, and QC personnel involved in handling HPRMs are trained in proper safety protocols, including spill response and emergency procedures.
    2. Conduct a pre-receipt safety briefing to review the hazards associated with the specific HPRMs being received.

5.2 Receiving and Initial Inspection

  1. Unloading and Handling

    1. Unload HPRMs carefully using appropriate lifting equipment to avoid damage or spillage.
    2. Ensure that personnel are wearing the required PPE and that the receiving area is secured from unauthorized access.
  2. Visual Inspection of Packaging and Labeling

    1. Inspect external packaging for signs of damage, leakage, or tampering.
    2. Verify that the packaging is properly sealed and labeled with hazard symbols, handling instructions, and supplier information.
    3. Ensure that the inner containers are intact and that desiccants or moisture indicators, if applicable, are in good condition.
See also  SOP for Inspection of Recycled or Reprocessed Raw Materials - V 2.0

5.3 Documentation and Quarantine

  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 name, and PO number.
      • Material name, batch number, and quantity.
      • Inspection findings related to packaging, labeling, and potential hazards.
    2. Document any discrepancies or issues in the remarks section and notify QA immediately.
  2. Quarantine and Labeling

    1. Segregate HPRMs in a designated quarantine area with appropriate signage indicating “Highly Potent Material – Quarantine.”
    2. Label materials based on their inspection status:
      • “Hold” for materials pending QA review and QC testing.
      • “Rejected” for materials with visible damage, contamination, or incorrect labeling.

5.4 QA Review and QC Testing

  1. QA Review of Documentation and Inspection Findings

    1. QA reviews inspection records, MSDS, and supplier documentation to ensure compliance with safety and quality standards.
    2. For materials in quarantine, QA performs a secondary inspection and assesses whether additional containment or testing is required.
  2. QC Sampling and Analytical Testing

    1. QC conducts sampling and analytical testing in a controlled environment, using appropriate containment measures (e.g., isolators, fume hoods).
    2. Perform tests for identity, potency, purity, and contamination according to company SOPs.
    3. Document test results and communicate findings to QA for final disposition.

5.5 Final Disposition

  1. Acceptance

    1. Materials that meet all safety and quality criteria are labeled “Accepted” and moved to the designated storage area under controlled conditions.
    2. Update the Raw Material Receiving Register to reflect the accepted status and ensure traceability.
  2. Rejection

    1. Materials that fail inspection or QC testing due to safety or quality concerns are labeled “Rejected” and moved to the designated rejection area with appropriate containment measures.
    2. Document the reason for rejection in the receiving register and initiate a non-conformance report.
  3. Supplier Notification and Corrective Action

    1. Procurement contacts the supplier to report issues related to HPRMs and coordinates returns, replacements, or corrective actions.
    2. Document all communications with the supplier and ensure compliance with regulatory reporting requirements for hazardous materials.
See also  SOP for Receiving Raw Materials Packed in Drums, Bags, and Carboys - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • MSDS: Material Safety Data Sheet
  • HPRM: Highly Potent Raw Material
  • OHS: Occupational Health and Safety

7. Documents

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

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
  • OSHA Hazard Communication Standard (29 CFR 1910.1200)
  • 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 Highly Potent API-X X-2025-001 PO-12345 10 kg Packaging Intact, Proper Labeling Accepted
02/02/2025 XYZ Pharma Potent Excipient-Y Y-2025-002 PO-67890 5 kg Leak Detected, Inner Seal Damaged Quarantined, Pending QA Review

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result Remarks
01/02/2025 Highly Potent API-X X-2025-001 John Doe Potency and Purity Test Pass Approved for Use
03/02/2025 Potent Excipient-Y Y-2025-002 Jane Smith Contamination Check 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 handling highly potent raw materials.
01/02/2025 2.0 Enhanced Safety and Inspection Protocols Standardization of Document QA Head All All Added detailed PPE requirements and revised deviation handling procedures.
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