analysts are appropriately trained, qualified, and authorized to perform assigned tasks in compliance with GMP, ICH Q10, and organizational standards.

2. Scope

This SOP applies to all personnel performing or supporting analytical method development activities in the AMD department, including full-time analysts, contract staff, and trainees involved in API or formulation analysis.

3. Responsibilities

• Training Coordinator / QA: Maintains and updates the training matrix based on SOP revisions and analyst performance reviews.
• Functional Trainer: Conducts technical training, evaluates practical skills, and documents training outcomes.
• Analyst: Actively participates in training programs, performs assigned methods post-qualification only.
• Head – AMD: Approves training modules, matrix entries, and monitors analyst competency progression.

4. Accountability

The Head of AMD is accountable for ensuring that the training matrix reflects current competency levels and that untrained staff do not perform unauthorized analytical tasks.

5. Procedure

5.1 Training Matrix Design

1. Create a matrix format listing:
   • Names of all analysts
   • Specific methods, equipment, and GMP topics
   • Training levels: Trained (T), Qualified (Q), Trainer (R)
2. Use Annexure-1: AMD Training Matrix Template for documentation.

5.2 Skill Assessment Categories

1. Define skill areas including but not limited to:
   • UV-Vis Spectrophotometry
   • HPLC & GC Operation
   • Method Development Protocol Writing
   • Sample Handling & Documentation
   • Software (e.g., Empower, LabSolutions)
   • cGMP, ALCOA+ Principles
2. Each category is evaluated individually through practical assessment and theoretical quizzes.

5.3 Training Assignment and Execution

1. Based on job role and development focus, the Training Coordinator assigns a trainer.
2. Trainer delivers:
   • Classroom instruction (theory)
   • Hands-on demonstration (practice)
   • Mock exercises or shadow sessions
3. Training is documented in Annexure-2: Analyst Training Record Sheet.

5.4 Qualification Criteria

1. Analyst must demonstrate:
   • Minimum 2 successful independent runs under supervision
   • 100% accuracy in documentation
   • Knowledge of relevant SOPs and instruments
2. Qualification result is evaluated and recorded using Annexure-3: Skill Evaluation Checklist.

5.5 Matrix Review and Updates

1. Update the matrix:
   • Upon method revision
   • After CAPA or retraining
   • During quarterly review or new analyst induction
2. QA to audit the matrix quarterly to ensure regulatory readiness and availability of current training data.

5.6 Restrictions on Untrained Personnel

1. Only analysts marked “Qualified (Q)” may independently perform respective analytical activities.
2. Trained but unqualified analysts must work under supervision of “Trainer (R)” status staff.
3. Violations to be documented as per SOP/QA/043/2025 – Noncompliance Handling.

6. Abbreviations

• AMD: Analytical Method Development
• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available

7. Documents

1. AMD Training Matrix Template – Annexure-1
2. Analyst Training Record Sheet – Annexure-2
3. Skill Evaluation Checklist – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO TRS 986 – Annex 2: Good Practices in QA Training
• 21 CFR Part 211.25 – Personnel Qualifications

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: AMD Training Matrix Template

Analyst	HPLC	GC	UV	SOP Writing	Empower	Qualified Trainer
Ajay Mehra	Q	Q	T	Q	T	No
Sunita Reddy	R	Q	Q	R	Q	Yes

Annexure-2: Analyst Training Record Sheet

Analyst Name	Method	Trainer	Date Started	Date Completed	Status
Rajesh Kumar	HPLC for Assay	Sunita Reddy	01/05/2025	08/05/2025	Qualified

Annexure-3: Skill Evaluation Checklist

Criteria	Score	Pass/Fail	Remarks
Accurate Sample Prep	100%	Pass	Compliant
Instrument Operation	95%	Pass	Minor alert handled
Documentation	100%	Pass	Neat and signed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Expanded matrix scope to include software & updated evaluation criteria	Internal Audit Recommendation