pharmaceutical ingredients, excipients, preservatives, gelling agents, and other raw materials used in gel formulation within the Gel Manufacturing department.

3. Responsibilities

• QA Department: Plan, schedule, conduct audits, and compile audit reports.
• Purchase/Procurement: Coordinate logistics and documentation with suppliers.
• Manufacturing Department: Provide feedback on material performance in production.
• Auditor Team: Execute on-site or remote audits and evaluate supplier facilities and quality systems.

4. Accountability

Head of Quality Assurance is accountable for the final approval of audit findings and decisions related to supplier qualification or disqualification.

5. Procedure

5.1 Supplier Selection and Audit Planning

1. Create and maintain an Approved Vendor List (AVL) based on historical data and criticality of raw materials.
2. Identify and prioritize suppliers for auditing based on:
   • Type of raw material (API, excipient, preservative)
   • Material criticality and usage frequency
   • Regulatory history and past deviations
3. Prepare a yearly audit plan with tentative dates and scope for each supplier.

5.2 Audit Preparation

1. QA prepares the audit agenda and checklist (Annexure-1) covering:
   • Facility hygiene and GMP infrastructure
   • Raw material testing capabilities
   • Document control and change management
   • Regulatory compliance and certifications
2. Send audit intimation to the supplier at least 2 weeks in advance.
3. Form an audit team including QA and subject matter experts (SMEs).

5.3 Conducting the Audit

1. Conduct opening meeting with supplier representatives.
2. Perform facility walkthrough and document review based on the audit checklist.
3. Note observations, deficiencies, and positive practices.
4. Discuss preliminary findings during the closing meeting.

5.4 Reporting and Follow-Up

1. Prepare the Supplier Audit Report within 7 working days of the audit (Annexure-2).
2. Classify observations as Critical, Major, or Minor.
3. Share the report with the supplier and request Corrective and Preventive Actions (CAPA).
4. Review and approve CAPA within 15 days of receipt.
5. Update vendor status based on audit outcome:
   • Approved
   • Conditionally Approved
   • Disqualified

5.5 Documentation and Retention

• All audit reports, CAPAs, and supporting documents must be retained for a minimum of 5 years.
• Maintain electronic backup of all audit records in validated QMS software.

6. Abbreviations

• QA: Quality Assurance
• CAPA: Corrective and Preventive Actions
• GMP: Good Manufacturing Practice
• AVL: Approved Vendor List
• SME: Subject Matter Expert

7. Documents

1. Audit Checklist – Annexure-1
2. Supplier Audit Report Template – Annexure-2
3. CAPA Tracking Log – Annexure-3
4. Vendor Qualification Approval Form – Annexure-4

8. References

• ICH Q10: Pharmaceutical Quality System
• EU GMP Chapter 7 – Outsourced Activities
• FDA CFR 21 Part 211

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Supplier Audit Checklist

Audit Parameter	Compliant (Yes/No)	Remarks
GMP Compliance
Cleaning & Hygiene
Raw Material Sampling Practices
Change Control System
Document Traceability

Annexure-2: Supplier Audit Report

Supplier Name
Address
Date of Audit
Audit Team
Summary of Observations
Classification of Observations	Critical / Major / Minor
CAPA Required

Annexure-3: CAPA Tracking Log

Observation No.	Description	CAPA Proposed	Status	Closure Date
			Open/Closed

Annexure-4: Vendor Qualification Approval Form

Vendor Name
Qualification Status	Approved / Conditionally Approved / Disqualified
Justification
Approval By	QA Head

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Added CAPA tracking format	Annual Review	QA Head