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

1. Conduct a Training Needs Assessment (TNA) using the Training Matrix (Annexure-1).
2. Identify personnel based on:
   • Role and function in CLD
   • Previous experience
   • Regulatory or procedural updates

5.2 Training Methods

1. 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
2. All training materials must be reviewed and approved by QA and department head.

5.3 Training Execution

1. Schedule training sessions as per Training Calendar (Annexure-2).
2. Ensure SME or qualified trainer delivers the session and records attendance in Training Log (Annexure-3).
3. Trainee shall sign the log upon completion of each module.

5.4 Evaluation and Qualification

1. Post-training assessment to be conducted using written quizzes or practical observation forms.
2. Minimum passing score is 80% for written and “Satisfactory” for practicals.
3. Issue Training Completion Certificate (Annexure-4) after successful evaluation.

5.5 Retraining and Continuous Learning

1. Retraining shall be conducted in the following cases:
   • Annual GMP refresher programs
   • Post-deviation involving human error
   • Major SOP revision
2. Maintain retraining records with justification and trainer remarks.

5.6 Documentation and Archival

1. Training logs and certificates shall be filed in the individual employee training file.
2. 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

1. Training Matrix – Annexure-1
2. Training Calendar – Annexure-2
3. Training Log – Annexure-3
4. 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