SOP Guide for Pharma

SOP for Acceptance Criteria for Receiving of Raw Materials – V 2.0

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SOP for Acceptance Criteria for Receiving of Raw Materials – V 2.0

Standard Operating Procedure for Acceptance Criteria for Receiving of Raw Materials

Department Warehouse / Quality Assurance / Quality Control / Procurement
SOP No. SOP/RM/055/2025
Supersedes SOP/RM/055/2022
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) defines the acceptance criteria for raw materials received at the facility. The aim is to ensure that all incoming materials meet predefined quality, safety, and regulatory standards, maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials received at the facility, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials. It outlines the criteria for acceptance, inspection procedures, and documentation requirements.

3. Responsibilities

  • Warehouse Personnel: Perform initial inspection upon receipt, verify documentation, and report any discrepancies.
  • Quality Assurance (QA): Review inspection reports, approve or reject materials based on compliance with acceptance criteria.
  • Quality Control (QC): Conduct sampling and testing of raw materials to confirm compliance with specifications.
  • Procurement Department: Ensure suppliers adhere to the agreed quality specifications and resolve any issues related to non-conforming materials.

4. Accountability

The Warehouse Manager is responsible for ensuring that initial

inspections and documentation are conducted accurately. The QA Manager holds authority to approve or reject materials based on compliance with acceptance criteria, while the Procurement Manager ensures supplier adherence to material specifications. The QC Manager oversees testing and quality evaluation of raw materials.
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5. Procedure

5.1 General Acceptance Criteria

  1. Documentation Compliance:
    • Verify that the following documents are provided and complete:
      • Certificate of Analysis (CoA)
      • Material Safety Data Sheet (MSDS)
      • Purchase Order (PO)
      • Bill of Lading/Delivery Note
    • Document verification details in the Documentation Compliance Log (Annexure-1).
  2. Packaging Integrity:
    • Check for intact and tamper-evident packaging with no signs of damage, leakage, or contamination.
    • Ensure all labels are legible, including material name, batch number, manufacturing date, expiry date, and supplier details.
    • Document findings in the Packaging Inspection Log (Annexure-2).
  3. Quantity Verification:
    • Verify that the quantity received matches the Purchase Order (PO) and delivery note.
    • Document quantity verification in the Material Quantity Log (Annexure-3).

5.2 Specific Acceptance Criteria

  1. Temperature-Sensitive Materials:
    • Ensure materials requiring controlled temperatures are received within the specified range (e.g., 2-8°C, 15-25°C).
    • Review temperature monitoring devices (e.g., data loggers) and document compliance in the Temperature Compliance Log (Annexure-4).
  2. Hazardous Materials:
    • Confirm proper labeling, including hazard symbols, and ensure materials are transported according to safety regulations.
    • Document hazardous material checks in the Hazardous Material Inspection Log (Annexure-5).
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5.3 Sampling and Testing

  1. Sampling Procedure:
    • QC personnel perform sampling according to the Sampling SOP.
    • Ensure samples are taken in a clean environment to prevent contamination.
    • Document sampling details in the Sampling Log (Annexure-6).
  2. Quality Testing:
    • Conduct identity, purity, and potency tests according to the material specifications.
    • Document test results in the QC Test Report (Annexure-7).

5.4 Material Disposition

  1. Approval of Materials:
    • Materials that meet all acceptance criteria are approved by QA and moved to the approved storage area.
    • Document approvals in the Material Approval Log (Annexure-8).
  2. Rejection of Materials:
    • Materials failing to meet acceptance criteria are rejected and moved to the rejection area.
    • Document rejections in the Material Rejection Log (Annexure-9).
    • Procurement contacts suppliers for corrective actions or replacements.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • API: Active Pharmaceutical Ingredient
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • CoA: Certificate of Analysis
  • MSDS: Material Safety Data Sheet

7. Documents

  1. Documentation Compliance Log (Annexure-1)
  2. Packaging Inspection Log (Annexure-2)
  3. Material Quantity Log (Annexure-3)
  4. Temperature Compliance Log (Annexure-4)
  5. Hazardous Material Inspection Log (Annexure-5)
  6. Sampling Log (Annexure-6)
  7. QC Test Report (Annexure-7)
  8. Material Approval Log (Annexure-8)
  9. Material Rejection Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • EU Guidelines on Good Distribution Practices (GDP)
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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Documentation Compliance Log

Date Material Name Batch Number CoA Provided MSDS Provided PO Compliance Verified By Remarks
01/02/2025 API-X X-2025-001 Yes Yes Yes John Doe All Documents Verified
01/02/2025 Excipient-Y Y-2025-002 No Yes No Jane Smith CoA Missing

Annexure-2: Packaging Inspection Log

Date Material Name Batch Number Packaging Condition Labeling Correct Inspected By Remarks
01/02/2025 API-X X-2025-001 Intact Yes John Doe Packaging Meets Standards
01/02/2025 Excipient-Y Y-2025-002 Torn Seal No Jane Smith Packaging Damage Reported

Annexure-3: Material Quantity Log

Date Material Name Batch Number Quantity Ordered Quantity Received Verified By Remarks
01/02/2025 API-X X-2025-001 100 kg 100 kg John Doe Quantity Matches PO
01/02/2025 Excipient-Y Y-2025-002 150 kg 145 kg Jane Smith Shortage Reported

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Added Temperature and Hazardous Material Acceptance Criteria Standardization QA Head
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