SOP Guide for Pharma

Biosimilars: SOP for Training Bioreactor Operators – V 2.0

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Biosimilars: SOP for Training Bioreactor Operators – V 2.0

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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.
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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

  1. 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

  1. 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
  2. Trainers to document topics and dates in Annexure-1: Training Record Sheet.

5.3 Hands-On Assessment

  1. Assign each trainee a supervised bioreactor operation simulation.
  2. Trainer evaluates:
    • SOP adherence
    • Equipment handling skill
    • Response to alarms and deviation scenarios
  3. Record results in Annexure-2: Practical Competency Checklist.
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5.4 Qualification and Certification

  1. Only candidates scoring ≥85% in theory and passing practical are certified.
  2. Issue operator certification valid for 1 year (Annexure-3: Certificate Log).

5.5 Refresher Training

  1. Conduct annual refresher sessions or upon:
    • SOP revision
    • Recurrent deviations
    • Audit observation

5.6 Training Record Retention

  1. Retain training files for each operator for a minimum of 5 years.
  2. Ensure records are accessible for internal/external audits.

6. Abbreviations

  • SIP: Steam-In-Place
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practice

7. Documents

  1. Training Record Sheet – Annexure-1
  2. Practical Competency Checklist – Annexure-2
  3. Certificate Log – Annexure-3

8. References

  • WHO TRS 1019 – GMP for Biological Products
  • ICH Q10 – Pharmaceutical Quality System
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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