Quality Assurance: SOP for Supplier Qualification Audits – V 2.0

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Quality Assurance: SOP for Supplier Qualification Audits – V 2.0

Standard Operating Procedure for Supplier Qualification Audits in Quality Assurance


Department Quality Assurance
SOP No. SOP/QA/187/2025
Supersedes SOP/QA/187/2022
Page No. Page 1 of 12
Issue Date 24/06/2025
Effective Date 26/06/2025
Review Date 24/06/2026

1. Purpose

This SOP defines the methodology and procedural requirements for conducting audits of suppliers involved in the provision of raw materials, packaging materials, and service providers related to sterile injectable manufacturing. It ensures that suppliers consistently meet regulatory expectations and

internal quality standards.

2. Scope

This SOP applies to all vendors supplying APIs, excipients, packaging components, and contract service providers. It includes initial qualification, requalification, audit scheduling, execution, reporting, and follow-up in sterile injectable production.

3. Responsibilities

  • QA Executive: Maintains supplier audit schedule and documentation.
  • Lead Auditor: Conducts the audit, prepares the audit report, and evaluates compliance status.
  • QA Manager: Reviews audit findings and approves audit conclusions.
  • Procurement Department: Initiates supplier onboarding and facilitates audit logistics.
  • Vendor Representative: Provides documents and access during the audit.
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4. Accountability

The Head of Quality Assurance is accountable for the overall execution and effectiveness of the supplier audit program, including approval of qualified supplier lists.

5. Procedure

5.1 Supplier Identification and Classification

  1. Suppliers are identified by the Procurement team and forwarded to QA for qualification.
  2. Classify suppliers based on risk:
    • High-risk: APIs, sterile components, critical packaging
    • Medium-risk: Excipients, labels
    • Low-risk: Secondary packaging, printed cartons

5.2 Audit Planning

  1. Maintain an Annual Supplier Audit Plan (Annexure-1) including frequency and audit type (initial, for-cause, or requalification).
  2. Notify suppliers at least two weeks in advance via formal audit intimation (Annexure-2).

5.3 Audit Execution

  1. Audit team to include minimum of one qualified Lead Auditor and one supporting auditor.
  2. Use Supplier Audit Checklist (Annexure-3) covering:
    • GMP compliance
    • Documentation systems
    • Quality control practices
    • Warehouse and production controls
    • Equipment maintenance
    • Change control and CAPA

5.4 Audit Reporting

  1. Prepare the Supplier Audit Report (Annexure-4) within 7 working days post audit.
  2. Classify findings:
    • Critical: Immediate corrective action required
    • Major: Corrective action within 30 days
    • Minor: Improvement recommended
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5.5 Corrective and Preventive Actions (CAPA)

  1. Share audit report with supplier and request CAPA plan (Annexure-5) within defined timelines.
  2. QA shall evaluate the adequacy and implementation of CAPA through remote follow-up or on-site verification.

5.6 Supplier Approval and Listing

  1. Only suppliers meeting audit criteria and with satisfactory CAPA implementation shall be approved.
  2. Update the Approved Vendor List (Annexure-6) accordingly.

5.7 Requalification and Surveillance

  1. High-risk suppliers to be requalified every 2 years; others every 3 years.
  2. Interim audits may be scheduled based on:
    • Change notification
    • Market complaints
    • Product quality issues

6. Abbreviations

  • QA: Quality Assurance
  • CAPA: Corrective and Preventive Action
  • GMP: Good Manufacturing Practice
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Annual Audit Plan – Annexure-1
  2. Audit Intimation Letter – Annexure-2
  3. Supplier Audit Checklist – Annexure-3
  4. Supplier Audit Report – Annexure-4
  5. CAPA Response Format – Annexure-5
  6. Approved Vendor List – Annexure-6

8. References

  • ICH Q10: Pharmaceutical Quality System
  • 21 CFR Part 211.84 – Testing and Approval of Components
  • WHO TRS 986 – GMP Guidelines for Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation QA Executive QA Manager Head QA
Department Quality Assurance Quality Assurance Quality Assurance
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11. Annexures

Annexure-1: Annual Audit Plan

Supplier Name Material Risk Level Scheduled Date Status
Ajanta Chemicals Sodium Citrate High 10/07/2025 Planned

Annexure-2: Audit Intimation Letter

Date 24/06/2025
To M/s Ajanta Chemicals
Subject Audit Intimation for Supplier Qualification
Signed By Rajesh Kumar (QA Manager)

Annexure-3: Supplier Audit Checklist

Area Checklist Points Compliant Remarks
Documentation SOPs in place for QC Yes Reviewed

Annexure-4: Supplier Audit Report

Supplier Ajanta Chemicals
Date of Audit 10/07/2025
Lead Auditor Sunita Reddy
Summary Compliant with minor observations in housekeeping.

Annexure-5: CAPA Response Format

Observation Proposed Action Timeline Responsible
Dust in warehouse Install air curtains 15/07/2025 Maintenance Head

Annexure-6: Approved Vendor List

Supplier Name Material Approval Date Status
Ajanta Chemicals Sodium Citrate 15/07/2025 Approved

Revision History:

Revision Date Revision No. Details Reason Approved By
01/04/2022 1.0 Initial Release New SOP QA Head
24/06/2025 2.0 Added requalification and CAPA annexures Annual Review QA Head
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