Standard Operating Procedure for Training Personnel in Cell Line Development Procedures
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/057/2025 |
| Supersedes | SOP/BS/057/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To establish a standardized training process for all personnel involved in Cell Line Development (CLD) operations in biosimilar manufacturing, ensuring technical competence, regulatory awareness, and compliance with GMP practices.
2. Scope
This SOP applies to newly inducted scientists, technicians, and existing staff in the biosimilar CLD department involved in gene transfection, clone screening, cell bank preparation, and related documentation.
3. Responsibilities
- Training Coordinator: Designs training calendar, maintains training records, and schedules assessments.
- Department Head: Approves training plans and ensures availability of subject matter experts (SMEs).
- Trainee: Attends training sessions, completes evaluations, and follows instructions.
4. Accountability
The Head of Biosimilars is accountable for ensuring all CLD personnel are trained, assessed, and qualified for their assigned tasks as per regulatory expectations.
5. Procedure
5.1 Training Need Identification
- Conduct a Training Needs Assessment (TNA) using the Training Matrix (Annexure-1).
- Identify personnel based on:
- Role and function in CLD
- Previous experience
- Regulatory or procedural updates
5.2 Training Methods
- Use the following formats:
- Classroom training for theory and SOP reviews
- Hands-on lab training for procedures like thawing, transfection, and screening
- On-the-job training (OJT) under supervision
- All training materials must be reviewed and approved by QA and department head.
5.3 Training Execution
- Schedule training sessions as per Training Calendar (Annexure-2).
- Ensure SME or qualified trainer delivers the session and records attendance in Training Log (Annexure-3).
- Trainee shall sign the log upon completion of each module.
5.4 Evaluation and Qualification
- Post-training assessment to be conducted using written quizzes or practical observation forms.
- Minimum passing score is 80% for written and “Satisfactory” for practicals.
- Issue Training Completion Certificate (Annexure-4) after successful evaluation.
5.5 Retraining and Continuous Learning
- Retraining shall be conducted in the following cases:
- Annual GMP refresher programs
- Post-deviation involving human error
- Major SOP revision
- Maintain retraining records with justification and trainer remarks.
5.6 Documentation and Archival
- Training logs and certificates shall be filed in the individual employee training file.
- Electronic copies to be archived on the QA-secured server with restricted access.
6. Abbreviations
- CLD: Cell Line Development
- SME: Subject Matter Expert
- TNA: Training Needs Assessment
- OJT: On-the-Job Training
7. Documents
- Training Matrix – Annexure-1
- Training Calendar – Annexure-2
- Training Log – Annexure-3
- Training Completion Certificate – Annexure-4
8. References
- EU GMP Chapter 2 – Personnel
- ICH Q10 – Pharmaceutical Quality System
- 21 CFR Part 211.25 – Training of Personnel
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 Matrix
| Employee Name | Role | Required Training | Completed |
|---|---|---|---|
| Ajay Verma | Junior Scientist | Transfection, MCB Preparation | Yes |
Annexure-2: Training Calendar
| Month | Topic | Trainer | Planned Date | Status |
|---|---|---|---|---|
| May 2025 | CLD Documentation SOP | Sunita Reddy | 10/05/2025 | Scheduled |
Annexure-3: Training Log
| Date | Topic | Trainee Name | Trainer | Signature |
|---|---|---|---|---|
| 02/05/2025 | ELISA-based Clone Screening | Vinay Pawar | Dr. Neha Singh |
Annexure-4: Training Completion Certificate
| Certificate No. | CLD/TRN/057/2025 |
|---|---|
| Employee Name | Vinay Pawar |
| Training Module | Stable Clone Development |
| Completion Date | 03/05/2025 |
| Trainer | Sunita Reddy |
| Remarks | Qualified |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Expanded evaluation criteria and added Annexure for certificate | Training System Upgrade |