Standard Operating Procedure for Evaluation of New Media Vendors in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/145/2025
Supersedes	SOP/BS/145/2022
Page No.	Page 1 of 9
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the procedure for evaluating and qualifying new suppliers of culture media and supplements used in biosimilar manufacturing to ensure consistency, performance, and GMP compliance.

2. Scope

This SOP applies to the assessment, testing, approval, and qualification of new vendors supplying chemically defined or complex culture media for use in upstream biosimilar production.

3. Responsibilities

• Supply Chain: Initiate vendor registration, collect documentation, and coordinate audits.
• QA: Review vendor documentation and approve the qualification status.
• QC: Conduct media quality testing including sterility, pH, osmolality, and performance.
• Process Development: Perform comparability studies using cell lines in small-scale models.

4. Accountability

The QA Head is accountable for final approval of media vendors and ensuring all activities align with regulatory guidelines and internal quality policies.

5. Procedure

5.1 Vendor Registration

1. Receive request for new vendor from Supply Chain.
2. Collect vendor credentials, including:
   • ISO/GMP certifications
   • COA and Material Safety Data Sheets (MSDS)
   • Quality Manual and change notification policy
3. Fill Annexure-1: Vendor Registration Form.

5.2 Initial Screening

1. QA to evaluate quality documents and conduct a risk assessment based on:
   • Supplier history
   • Geographic location
   • Quality system robustness
2. If satisfactory, approve initial sample evaluation.

5.3 Sample Evaluation

1. Receive sample and test for:
   • pH, osmolality, clarity
   • Sterility, endotoxin, and mycoplasma
2. Conduct small-scale culture study using internal reference clone and compare with reference media performance.
3. Record data in Annexure-2: Media Performance Log.

5.4 Audit and Qualification

1. Conduct on-site or virtual audit of the vendor if high-risk or critical media component is involved.
2. Use Annexure-3: Vendor Audit Checklist to document observations.
3. Assign status:
   • Approved
   • Conditionally Approved
   • Rejected

5.5 Periodic Review

1. Approved vendors must be re-evaluated every 2 years or upon a major change notification.
2. Maintain performance tracking in Annexure-4: Annual Vendor Review Log.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• MSDS: Material Safety Data Sheet
• COA: Certificate of Analysis

7. Documents

1. Vendor Registration Form – Annexure-1
2. Media Performance Log – Annexure-2
3. Vendor Audit Checklist – Annexure-3
4. Annual Vendor Review Log – Annexure-4

8. References

• ICH Q10 – Pharmaceutical Quality System
• EU GMP Chapter 5 – Production
• ISO 9001 – Quality Management Systems

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 Registration Form

Vendor Name	Location	Contact Person	Certifications	Status
BioMedix Pvt. Ltd.	Hyderabad	Rajesh Kumar	ISO 9001, GMP	Under Review

Annexure-2: Media Performance Log

Media ID	Clone	Viability (%)	Growth Rate	Titer (g/L)	Remarks
M-NEW-102	CHO-GSK07	95%	0.045/hr	1.8	Comparable

Annexure-3: Vendor Audit Checklist

Area	Observation	Compliant (Y/N)	Remarks
Storage	Ambient control verified	Y	Meets specs

Annexure-4: Annual Vendor Review Log

Vendor	Review Date	Performance Score	Action	Reviewed By
BioMedix Pvt. Ltd.	04/05/2025	93%	Retain	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Expanded audit and performance review section	Enhancement of vendor oversight