training, assigns mentors, maintains training logs.

Qualified Analyst (Trainer): Provides hands-on instrument training and evaluates trainee competency.

Trainee Analyst: Attends sessions, performs tasks under supervision, and completes evaluation modules.

QA Unit: Reviews training documentation and ensures adherence to training matrix.

4. Accountability

The Head of Bioanalytical Department is accountable for ensuring training is completed, assessed, and documented prior to analyst authorization on LC-MS/MS instruments.

5. Procedure

5.1 Training Enrollment and Planning

1. New analysts or analysts assigned to a new LC-MS/MS platform must be enrolled in training via Annexure-1: Training Request Form.
2. Assign a qualified mentor who has minimum 6 months hands-on experience with the instrument.
3. Define training timeline (typically 4–6 weeks) and topics in accordance with the Training Curriculum.

5.2 Training Curriculum

1. The training program shall include modules on:
   • System start-up and shutdown procedures
   • Instrument calibration and tuning
   • Sample loading and sequence creation
   • Data acquisition and processing
   • Manual integration and data review
   • Routine maintenance and troubleshooting
   • Audit trail review and data backup
2. The trainee shall perform all steps under direct observation of the mentor initially, followed by supervised repetition.

5.3 Evaluation of Competency

1. Upon completion, the mentor shall conduct a theoretical and practical assessment using Annexure-2: Training Evaluation Checklist.
2. Analyst must demonstrate:
   • Fluent software navigation (e.g., Analyst, MassLynx)
   • Accurate sequence setup and sample ID management
   • Troubleshooting for pressure drops, signal loss, or communication errors

5.4 Documentation

1. All training steps shall be recorded and signed in Annexure-3: Training Record Sheet.
2. Assessment scores and trainer recommendations must be recorded.
3. Analyst shall not operate instrument independently until certified in Annexure-4: Certificate of Completion.

5.5 Refresher and Cross-Training

1. Annual refresher training is mandatory or in case of:
   • Major software upgrades
   • Instrument model change
   • Extended absence (>3 months)
2. Cross-training to other LC-MS/MS platforms must follow this SOP again.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Training Request Form – Annexure-1
2. Training Evaluation Checklist – Annexure-2
3. Training Record Sheet – Annexure-3
4. Certificate of Completion – Annexure-4

8. References

• ICH M10: Bioanalytical Method Validation
• FDA Guidance on Bioanalytical Method Validation
• Internal Bioanalytical Training Policy

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 Request Form

Request Date	15/04/2025
Analyst Name	Sunita Reddy
Instrument Assigned	Sciex QTRAP 6500+
Trainer Assigned	Rajesh Kumar

Annexure-2: Training Evaluation Checklist

Module	Status	Comments
System Start/Stop	Completed	Clear understanding
Tuning	Completed	Proficient
Sequence Setup	Completed	Accurate

Annexure-3: Training Record Sheet

Date	Activity	Performed By	Trainer Initials
10/04/2025	Demo: LC pump setup	Sunita Reddy	RK
12/04/2025	Sample injection and acquisition	Sunita Reddy	RK

Annexure-4: Certificate of Completion

This certifies that Sunita Reddy has successfully completed training on Sciex QTRAP 6500+ LC-MS/MS system and is authorized to independently operate the instrument for routine bioanalytical work.

Date of Completion: 17/04/2025
Authorized By: Head – Bioanalytical Department

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial issue	New SOP	QA Head
17/04/2025	2.0	Added evaluation and certification steps	Compliance with ICH M10	QA Head