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Standard Operating Procedure for Training Bioreactor Operators in Biosimilar Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/119/2025 |
| Supersedes | SOP/BS/119/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To establish a structured and standardized training procedure for bioreactor operators involved in biosimilar upstream processing to ensure competency, regulatory compliance, and consistent operational performance.
2. Scope
This SOP applies to all new and existing operators assigned to bioreactor setup, operation, monitoring, sampling, and shutdown tasks in biosimilar production facilities.
3. Responsibilities
- Training Coordinator: Schedule, conduct, and document training activities.
- Department Head: Nominate trainees and ensure their timely qualification.
- QA: Review training records and approve final qualification status.
4. Accountability
The Head of Manufacturing is accountable for maintaining a fully trained and qualified pool of bioreactor operators aligned with GMP and safety guidelines.
5. Procedure
5.1 Induction Training
- All new hires must undergo induction covering:
- Company policies and SOP compliance
- Basic GMP principles and cleanroom behavior
- Personal hygiene and gowning
5.2 Technical Training Modules
- Conduct theory and practical sessions covering:
- Bioreactor parts and functions
- Sterile connections and SIP procedures
- pH, DO, and agitation control
- Batch documentation and log entries
- Inoculation, feeding, and sampling techniques
- Trainers to document topics and dates in Annexure-1: Training Record Sheet.
5.3 Hands-On Assessment
- Assign each trainee a supervised bioreactor operation simulation.
- Trainer evaluates:
- SOP adherence
- Equipment handling skill
- Response to alarms and deviation scenarios
- Record results in Annexure-2: Practical Competency Checklist.
5.4 Qualification and Certification
- Only candidates scoring ≥85% in theory and passing practical are certified.
- Issue operator certification valid for 1 year (Annexure-3: Certificate Log).
5.5 Refresher Training
- Conduct annual refresher sessions or upon:
- SOP revision
- Recurrent deviations
- Audit observation
5.6 Training Record Retention
- Retain training files for each operator for a minimum of 5 years.
- Ensure records are accessible for internal/external audits.
6. Abbreviations
- SIP: Steam-In-Place
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
7. Documents
- Training Record Sheet – Annexure-1
- Practical Competency Checklist – Annexure-2
- Certificate Log – Annexure-3
8. References
- WHO TRS 1019 – GMP for Biological Products
- ICH Q10 – Pharmaceutical Quality System
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Training Record Sheet
| Date | Module | Trainer | Trainee | Signature |
|---|---|---|---|---|
| 01/05/2025 | Bioreactor Basics | Ajay Verma | Sunita Reddy | Signed |
Annexure-2: Practical Competency Checklist
| Task | Criteria | Score | Remarks |
|---|---|---|---|
| pH Calibration | Correct SOP Use | 10/10 | Excellent |
Annexure-3: Certificate Log
| Trainee Name | Certificate ID | Date Issued | Valid Until | Issued By |
|---|---|---|---|---|
| Sunita Reddy | BR-CERT-2025-011 | 04/05/2025 | 04/05/2026 | Training Lead |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Added annual certification policy and certificate log annexure | Training compliance update |