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
- Classify GMOs into Risk Category I, II, or III as per Indian Biosafety Rules, 1989.
- Maintain classification record for each new construct (Annexure-1).
5.2 Containment Requirements
- Ensure all GMO manipulations are conducted in BSL-2 certified facilities.
- Work inside certified biosafety cabinets (Class II A2) during:
- Transformation/transfection
- Cell banking and media manipulations
- Harvesting and purification
- Maintain daily log of cabinet decontamination and use (Annexure-2).
5.3 Transport of GMOs
- Label GMO materials with:
- GMO ID
- Risk Category
- Biohazard symbol
- Transport in triple containment packaging if transferring to external sites.
- Document transport in GMO Movement Log (Annexure-3).
5.4 Incident Reporting and Emergency Response
- In case of spills or containment breach:
- Isolate area immediately
- Disinfect with 1% sodium hypochlorite
- Notify Biosafety Officer and document incident
- Complete GMO Incident Report (Annexure-4).
5.5 Waste Disposal
- Decontaminate all GMO waste by:
- Autoclaving at 121°C, 15 psi, for 30 minutes
- Incineration (if applicable)
- Dispose of according to BMW Rules, 2016 and CPCB guidelines.
5.6 Documentation and Records
- 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
- GMO Classification Record (Annexure-1)
- Biosafety Cabinet Usage Log (Annexure-2)
- GMO Movement Log (Annexure-3)
- 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 |