Standard Operating Procedure for Handling Genetically Modified Organisms (GMO) in Biosimilar Facilities

Department	Biosimilars
SOP No.	SOP/BS/037/2025
Supersedes	SOP/BS/037/2022
Page No.	Page 1 of 14
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the procedure for the safe handling, containment, documentation, and disposal of Genetically Modified Organisms (GMOs) used during biosimilar R&D and manufacturing, as per Indian and international biosafety regulations.

2. Scope

This SOP applies to all personnel involved in genetic engineering, cell line development, vector handling, and biosimilar process development involving GMO cell lines and expression systems.

3. Responsibilities

• Biosafety Officer: Oversees GMO use, maintains approvals, ensures containment and incident response readiness.
• Laboratory Personnel: Follow containment, PPE, waste handling, and documentation protocols while handling GMOs.
• QA Officer: Ensures compliance with GMO regulations and maintenance of GMO inventory and training records.

4. Accountability

The Head of Research & Development is accountable for ensuring institutional compliance with GMO handling guidelines and ensuring approvals from relevant authorities (e.g., IBSC, RCGM).

5. Procedure

5.1 GMO Risk Categorization

1. Classify GMOs into Risk Category I, II, or III as per Indian Biosafety Rules, 1989.
2. Maintain classification record for each new construct (Annexure-1).

5.2 Containment Requirements

1. Ensure all GMO manipulations are conducted in BSL-2 certified facilities.
2. Work inside certified biosafety cabinets (Class II A2) during:
   • Transformation/transfection
   • Cell banking and media manipulations
   • Harvesting and purification
3. Maintain daily log of cabinet decontamination and use (Annexure-2).

5.3 Transport of GMOs

1. Label GMO materials with:
   • GMO ID
   • Risk Category
   • Biohazard symbol
2. Transport in triple containment packaging if transferring to external sites.
3. Document transport in GMO Movement Log (Annexure-3).

5.4 Incident Reporting and Emergency Response

1. In case of spills or containment breach:
   • Isolate area immediately
   • Disinfect with 1% sodium hypochlorite
   • Notify Biosafety Officer and document incident
2. Complete GMO Incident Report (Annexure-4).

5.5 Waste Disposal

1. Decontaminate all GMO waste by:
   • Autoclaving at 121°C, 15 psi, for 30 minutes
   • Incineration (if applicable)
2. Dispose of according to BMW Rules, 2016 and CPCB guidelines.

5.6 Documentation and Records

1. Maintain following logs:
   • GMO Register
   • Approval letters from IBSC/RCGM
   • GMO Movement Log
   • Training Records

6. Abbreviations

• GMO: Genetically Modified Organism
• IBSC: Institutional Biosafety Committee
• RCGM: Review Committee on Genetic Manipulation
• BSL-2: Biosafety Level 2

7. Documents

1. GMO Classification Record (Annexure-1)
2. Biosafety Cabinet Usage Log (Annexure-2)
3. GMO Movement Log (Annexure-3)
4. GMO Incident Report (Annexure-4)

8. References

• Rules 1989 (under EPA Act) – Use of GMOs in India
• WHO Laboratory Biosafety Manual (4th Ed.)
• NIH Guidelines for Research Involving Recombinant DNA Molecules

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: GMO Classification Record

Date	GMO ID	Description	Risk Category	Classified By
02/05/2025	GMO-037-CHO	CHO-K1 expressing mAb	Category II	Sunita Reddy

Annexure-2: Biosafety Cabinet Usage Log

Date	Cabinet ID	Decontaminated	Used By	Purpose
02/05/2025	BSC-03	Yes	Rajesh Kumar	GMO inoculation

Annexure-3: GMO Movement Log

Date	GMO ID	Sent To	Transport Mode	Container Type	Remarks
02/05/2025	GMO-037-CHO	QA Lab	Hand Carry	Triple Packed	Internal transfer

Annexure-4: GMO Incident Report

Date	Incident	Location	Immediate Action	Reported By	Corrective Action
01/05/2025	Spill inside BSC	CLD Lab	Bleach disinfection	Ajay Verma	Cabinet maintenance scheduled

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Updated for BSL-2 containment and triple packaging transport	Regulatory enhancement