primary/secondary packaging materials.

3. Responsibilities

• Purchase Department: Identifies potential vendors and coordinates initial documentation.
• QA Department: Conducts technical review, audits, qualification, and maintains vendor approval status.
• QC Department: Evaluates incoming material quality and provides analytical feedback.
• Warehouse: Ensures material segregation and usage based on vendor status.

4. Accountability

The Head of Quality Assurance is accountable for vendor approval decisions and ensuring vendors continuously meet GMP standards and product quality requirements.

5. Procedure

5.1 Vendor Categorization

1. Vendors shall be categorized based on the type of material supplied:
   • Category A: API starting materials, solvents, reagents
   • Category B: Packaging materials (labels, containers)
   • Category C: Other service providers (e.g., testing labs, logistics)

5.2 Vendor Qualification Process

1. Qualification steps:
   • Request vendor for Vendor Questionnaire (Annexure-1)
   • Obtain technical dossier including:
     • GMP certificate
     • Manufacturing license
     • ISO/DMF/CEP certifications (if applicable)
     • Material specifications and CoA formats
   • Perform site audit for Category A vendors using Vendor Audit Checklist (Annexure-2)
   • Evaluate documentation and assign qualification status:
     • Approved
     • Conditionally Approved
     • Not Approved
2. Document all findings in the Vendor Qualification Report (Annexure-3).

5.3 Evaluation Criteria

1. Qualification decision is based on:
   • Material quality performance (initial 3 lots)
   • Compliance to specifications and regulatory documentation
   • Audit observations (if applicable)
   • History of complaints or deviations

5.4 Vendor Re-Evaluation

1. Re-evaluation to be conducted:
   • Annually for critical material suppliers
   • Biennially for packaging and non-critical vendors
   • Immediately in case of quality failures or regulatory alerts
2. Parameters for re-evaluation:
   • Lot rejection rates
   • Complaint history
   • Changes in ownership or manufacturing process
   • Updated regulatory documentation
3. Record re-evaluation details in Vendor Re-Evaluation Form (Annexure-4)

5.5 Vendor Status Management

1. Maintain Approved Vendor List (Annexure-5) with:
   • Vendor Name
   • Material Supplied
   • Approval Date
   • Status (Approved, Conditional, Blacklisted)
2. Ensure that ERP/SAP system reflects current vendor status to prevent unapproved material usage.

5.6 Disqualification of Vendors

1. Vendor may be disqualified due to:
   • Repeated quality failures
   • Audit non-compliance
   • Regulatory warning letters
   • Non-fulfillment of contractual obligations
2. Disqualification must be documented and justified in Vendor Disqualification Form (Annexure-6).

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice
• DMF: Drug Master File
• ERP: Enterprise Resource Planning

7. Documents

1. Vendor Questionnaire (Annexure-1)
2. Vendor Audit Checklist (Annexure-2)
3. Vendor Qualification Report (Annexure-3)
4. Vendor Re-Evaluation Form (Annexure-4)
5. Approved Vendor List (Annexure-5)
6. Vendor Disqualification Form (Annexure-6)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Subpart E: Control of Components and Drug Product Containers and Closures
• EU GMP Guidelines – Chapter 5

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Vendor Questionnaire

Vendor Name	Address	GMP Certified	ISO Certified	Regulatory Filings
ABC Chemicals	Mumbai	Yes	ISO 9001	DMF Filed (US/EU)

Annexure-2: Vendor Audit Checklist

Section	Audit Criteria	Compliance	Remarks
Manufacturing Area	Cleanliness, Layout	Yes	Acceptable
Documentation	Batch records, SOPs	Yes	Complete

Annexure-3: Vendor Qualification Report

Vendor	Material	Audit Result	Decision	Date
ABC Chemicals	Toluene	Compliant	Approved	01/04/2025

Annexure-4: Vendor Re-Evaluation Form

Vendor	Material	Last Evaluation	Observations	Re-Approval
XYZ Corp	IPA	02/03/2024	Minor Deviation	Yes

Annexure-5: Approved Vendor List

Vendor	Material	Status	Approval Date
ABC Chemicals	Solvents	Approved	01/04/2025

Annexure-6: Vendor Disqualification Form

Vendor	Reason	Disqualification Date	Approved By
DEF Labs	Repeated CoA failures	10/04/2025	QA Head

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
14/04/2025	2.0	Included audit and re-evaluation templates	Compliance update	QA Head