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.

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

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

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