active pharmaceutical ingredients (APIs), excipients, and solvents used in the manufacturing of sterile injectable products.

3. Responsibilities

• Purchase Department: Initiate supplier evaluation and provide documentation.
• Quality Assurance (QA): Conduct document review, risk assessment, and audit coordination.
• Quality Control (QC): Review CoA and conduct laboratory testing for supplied materials.
• Audit Team: Perform supplier audits as per risk classification.

4. Accountability

The Head of Quality Assurance is accountable for the final approval and qualification status of all raw material suppliers used in sterile injectable manufacturing.

5. Procedure

5.1 Initiation of Supplier Qualification

1. Purchase Department identifies new supplier and sends Supplier Evaluation Request Form (Annexure-1) to QA.
2. QA issues Supplier Questionnaire (Annexure-2) to the identified supplier.

5.2 Document Collection and Review

1. Required documents include:
   • Valid manufacturing license
   • ISO/GMP certification
   • Organizational structure
   • List of analytical instruments
   • Recent audit reports
2. QA reviews the documentation and completes the Preliminary Evaluation Report (Annexure-3).

5.3 Risk Classification

1. Suppliers are classified based on:
   • Material criticality (API vs. excipient)
   • Compliance history
   • Audit results
2. High-risk suppliers require on-site audits; low-risk may be qualified based on documentation.

5.4 Supplier Audit

1. QA schedules an audit for medium and high-risk suppliers.
2. Audit checklist includes:
   • Facility hygiene and cleanliness
   • Storage practices
   • Deviation handling system
   • Product traceability
3. Audit findings are documented in Supplier Audit Report (Annexure-4).

5.5 Approval and Listing

1. Based on the audit and evaluation, QA assigns status:
   • Approved
   • Conditionally Approved
   • Not Approved
2. Approved suppliers are added to the Approved Supplier List (Annexure-5).

5.6 Requalification

1. Requalification is performed every 2 years or earlier if issues arise.
2. Includes review of supply performance, complaint records, and regulatory changes.

5.7 Disqualification

1. Supplier may be disqualified due to:
   • Repeated quality failures
   • Regulatory non-compliance
   • Poor audit outcomes
2. Disqualified suppliers are removed from the Approved Supplier List and notified formally.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• API: Active Pharmaceutical Ingredient
• GMP: Good Manufacturing Practice

7. Documents

1. Supplier Evaluation Request Form – Annexure-1
2. Supplier Questionnaire – Annexure-2
3. Preliminary Evaluation Report – Annexure-3
4. Supplier Audit Report – Annexure-4
5. Approved Supplier List – Annexure-5

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• EU GMP Guidelines Part I Chapter 5 – Production
• WHO Technical Report Series No. 986

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Supplier Evaluation Request Form

Requested By	Sunil Mehta
Department	Procurement
Material Name	Sodium Chloride
Date	01/06/2025

Annexure-2: Supplier Questionnaire

Company Name	AB Chemicals Ltd.
Manufacturing Site Address	Navi Mumbai, Maharashtra
GMP Certified	Yes
Primary Contact	Ravi Desai

Annexure-3: Preliminary Evaluation Report

QA Reviewer	Rashmi Kaur
Date	03/06/2025
Document Completeness	Satisfactory
Comments	Recommended for audit

Annexure-4: Supplier Audit Report

Audit Date	06/06/2025
Auditor Name	Santosh Nair
Findings	No major observations
Status	Approved

Annexure-5: Approved Supplier List

Supplier Name	Material	Status	Approval Date
AB Chemicals Ltd.	Sodium Chloride	Approved	08/06/2025

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Updated risk classification and annexures	Periodic Review	QA Head