Standard Operating Procedure for Biosafety Monitoring in Biosimilar Upstream Laboratories

Department	Biosimilars
SOP No.	SOP/BS/115/2025
Supersedes	SOP/BS/115/2022
Page No.	Page 1 of 12
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To establish a standardized procedure for biosafety monitoring in upstream laboratories handling biosimilar cell cultures to ensure the protection of personnel, containment of biological agents, and compliance with applicable GMP and biosafety regulations.

2. Scope

This SOP applies to all personnel and activities in upstream processing labs involved in cell banking, inoculation, bioreactor operations, and any processes using live recombinant or non-recombinant cell lines.

3. Responsibilities

• Laboratory Staff: Adhere to biosafety protocols and report incidents or hazards.
• Biosafety Officer: Conduct periodic risk assessments, review PPE compliance, and approve decontamination plans.
• EHS Department: Monitor environmental biosafety indicators and coordinate training programs.

4. Accountability

The Head of Biosafety is accountable for the implementation, auditing, and improvement of biosafety practices in upstream labs.

5. Procedure

5.1 Biosafety Risk Assessment

1. Conduct initial and annual risk assessments of all upstream activities.
2. Identify hazards associated with:
   • Cell lines used (e.g., CHO, HEK293)
   • Vectors or viral components (if applicable)
   • Bioreactor effluent
3. Classify activities as Biosafety Level 1 or 2 and document in Annexure-1.

5.2 Environmental Monitoring and Biosafety Controls

1. Perform weekly swab testing of:
   • Workbenches
   • Door handles
   • Incubator interiors
2. Monitor airborne microbial levels monthly using settle plates and RCS systems.
3. Log all data in Annexure-2 and report out-of-spec to QA and Biosafety Officer.

5.3 PPE and Access Control Compliance

1. Verify PPE adherence during lab walkthroughs:
   • Gloves, gowns, face shields, masks
2. Restrict access to authorized staff via card-based or biometric entry.
3. Non-compliance must be documented in deviation form and reviewed.

5.4 Incident Reporting and Spill Management

1. All accidental exposures or spills must be reported within 15 minutes to the Biosafety Officer.
2. Use SOP-defined disinfectants (1% sodium hypochlorite, 70% IPA) for cleanup.
3. Submit Incident Report (Annexure-3) and investigate root cause within 48 hours.

5.5 Biosafety Audits

1. Perform quarterly biosafety audits using a checklist approved by QA and EHS.
2. Record findings in Annexure-4 and track CAPAs to closure.

6. Abbreviations

• PPE: Personal Protective Equipment
• EHS: Environment, Health, and Safety
• RCS: Rotor Centrifugal Sampler
• CAPA: Corrective and Preventive Action

7. Documents

1. Biosafety Risk Assessment Form – Annexure-1
2. Biosafety Monitoring Log – Annexure-2
3. Incident Report Form – Annexure-3
4. Biosafety Audit Checklist – Annexure-4

8. References

• WHO Biosafety Manual, 4th Edition
• OSHA Laboratory Safety Guidance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Biosafety Risk Assessment Form

Process	Hazard Identified	Risk Level	Control Measures	Assessed By
MCB Expansion	Spill exposure	Moderate	PPE, SOP cleanup	Ajay Verma

Annexure-2: Biosafety Monitoring Log

Date	Area	Sample Type	Result	Remarks
04/05/2025	Incubator Room	Swab	No Growth	Acceptable

Annexure-3: Incident Report Form

Date	Incident	Reported By	Immediate Action	Corrective Measure
03/05/2025	Media spill	Sunita Reddy	Cleaned with IPA	Retrained on handling

Annexure-4: Biosafety Audit Checklist

Audit Area	Checklist Point	Compliant (Y/N)	Remarks
Gowning Area	Mask and gloves worn	Y	—

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Added audit procedure and updated PPE policy tracking	Annual review update