SOP for Accepting and Handling of Herbal Raw Materials – V 2.0

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SOP for Accepting and Handling of Herbal Raw Materials – V 2.0

Standard Operating Procedure for Accepting and Handling of Herbal Raw Materials

Department Warehouse / Quality Assurance / Quality Control / Procurement
SOP No. SOP/RM/045/2025
Supersedes SOP/RM/045/2022
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 the procedures for the proper acceptance, handling, and storage of herbal raw materials. Herbal materials are susceptible to contamination, degradation, and variability, requiring stringent handling to maintain their quality and efficacy. This SOP ensures:

  • Systematic verification and acceptance of herbal raw materials according to regulatory and quality standards.
  • Proper handling and storage to prevent contamination, degradation, and cross-contamination.
  • Documentation and traceability of all received herbal materials.
  • Coordination between Warehouse, Quality Assurance (QA), Quality Control (QC), and Procurement teams.

2. Scope

This SOP applies to all herbal raw materials received and handled within the facility, including whole plants, plant parts, powders, extracts, and resins. It includes:

  • Procedures for receiving, inspecting, sampling, and storing herbal raw materials.
  • Responsibilities for ensuring compliance with regulatory requirements, including Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP).
  • Handling of deviations, non-conformance, and contamination risks specific to herbal materials.

3. Responsibilities

  • Warehouse Personnel:

    • Receive and inspect herbal raw materials upon arrival for signs of contamination, damage, or degradation.
    • Ensure proper labeling, segregation, and storage conditions to maintain material integrity.
    • Document receipt details in the Herbal Raw Material Receiving Register (Annexure-1) and notify QA.
  • Quality Assurance (QA) Team:

    • Review and verify documentation provided with herbal raw materials, including Certificates of Analysis (CoA) and Certificates of Origin (CoO).
    • Approve or reject materials based on inspection and QC testing results.
    • Ensure compliance with GMP, GACP, and regulatory standards.
  • Quality Control (QC) Team:

    • Conduct sampling and laboratory testing for microbial contamination, pesticides, heavy metals, and other contaminants.
    • Verify the identity, purity, and potency of herbal raw materials.
    • Document analytical results and provide recommendations to QA for material disposition.
  • Procurement Department:

    • Ensure suppliers provide complete and accurate documentation, including GACP certification where applicable.
    • Coordinate with QA and Warehouse for timely resolution of discrepancies or non-conformance issues.
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4. Accountability

The Warehouse Manager is responsible for the proper receipt, storage, and handling of herbal raw materials. The QA Manager holds the authority to approve or reject materials based on compliance with regulatory and quality standards. The QC Manager is accountable for ensuring that herbal materials meet identity, purity, and safety requirements. The Procurement Manager is responsible for sourcing from compliant suppliers and ensuring accurate documentation.

5. Procedure

5.1 Pre-Receipt Preparations

  1. Supplier Qualification and Documentation Review

    1. Procurement ensures that all suppliers are qualified and compliant with GACP and GMP standards.
    2. Regulatory documentation required before shipment includes:
      • Certificate of Analysis (CoA).
      • Certificate of Origin (CoO).
      • Pesticide Residue Analysis Report (if applicable).
      • Supplier GACP certification.
    3. QA verifies that all documentation is complete before accepting the shipment.

5.2 Receiving and Initial Inspection

  1. Visual Inspection by Warehouse Personnel

    1. Upon receipt of herbal raw materials, inspect for the following:
      • Physical damage to packaging or containers.
      • Signs of mold, pests, or foreign particles.
      • Unusual odors, discoloration, or other visible signs of contamination.
    2. Document inspection results in the Herbal Raw Material Receiving Register (Annexure-1).
  2. Labeling and Segregation

    1. Label materials with a unique batch number, date of receipt, and “UNDER TEST” status.
    2. Segregate materials in the quarantine area pending QA and QC approval.
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5.3 Sampling and Testing of Herbal Raw Materials

  1. Sampling Procedure

    1. QC personnel conduct sampling in a controlled environment to prevent contamination.
    2. Samples are collected using clean, sterile equipment and stored in labeled containers.
    3. Document sampling details in the Sampling Log (Annexure-2).
  2. Laboratory Testing

    1. QC conducts the following tests to ensure the quality and safety of herbal raw materials:
      • Identity testing using Thin Layer Chromatography (TLC) or High-Performance Liquid Chromatography (HPLC).
      • Microbial testing for bacterial and fungal contamination.
      • Pesticide residue analysis and heavy metal testing.
      • Moisture content analysis to ensure proper drying and prevent mold growth.
    2. Record analytical results in the QC Testing Report (Annexure-3).

5.4 Final Disposition of Herbal Raw Materials

  1. Approval or Rejection by QA

    1. QA reviews the QC Testing Report and approves or rejects the material based on test results.
    2. Approved materials are labeled “APPROVED” and moved to designated storage areas with appropriate environmental controls (temperature, humidity).
    3. Rejected materials are labeled “REJECTED” and moved to the rejection area for disposal.
    4. Document the final disposition in the Herbal Material Disposition Log (Annexure-4).

5.5 Handling of Non-Conforming Herbal Materials

  1. Supplier Communication and Corrective Actions

    1. Procurement contacts the supplier to address non-conformance and requests corrective actions.
    2. Ensure that suppliers investigate and rectify the root cause of non-conformance.
    3. Document all supplier communications and corrective actions in the Non-Conformance Report (Annexure-5).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • GACP: Good Agricultural and Collection Practices
  • QA: Quality Assurance
  • QC: Quality Control
  • CoA: Certificate of Analysis
  • CoO: Certificate of Origin

7. Documents

  1. Herbal Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2)
  3. QC Testing Report (Annexure-3)
  4. Herbal Material Disposition Log (Annexure-4)
  5. Non-Conformance Report (Annexure-5)
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8. References

  • 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
  • WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants
  • ICH Q7 – GMP for Active Pharmaceutical Ingredients
  • Company-Specific Quality and Procurement 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: Herbal Raw Material Receiving Register

Date Supplier Name Material Name Batch Number PO Number Inspection Findings Quarantine Status Remarks
01/02/2025 Green Herb Suppliers Ashwagandha Root Powder ASH-2025-001 PO-12345 No Visible Contamination Under Test Pending QC Approval
02/02/2025 Nature’s Best Botanicals Turmeric Extract TUR-2025-002 PO-67890 Unusual Odor Detected Quarantined QC Testing in Progress

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel Sample ID QC Test Performed Result
01/02/2025 Ashwagandha Root Powder ASH-2025-001 John Doe SAMP-001 Microbial Testing Pass
02/02/2025 Turmeric Extract TUR-2025-002 Jane Smith SAMP-002 Heavy Metal Testing Pending

Annexure-3: QC Testing Report

Report Number Date Material Name Batch Number Test Performed Result Conclusion
QC-001/2025 01/02/2025 Ashwagandha Root Powder ASH-2025-001 Microbial Testing Pass Approved
QC-002/2025 02/02/2025 Turmeric Extract TUR-2025-002 Heavy Metal Testing Fail 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 procedures for accepting and handling herbal raw materials.
01/02/2025 2.0 Added GACP Compliance Requirements Standardization of Document QA Head All All Included additional controls for GACP certification and supplier qualification.
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