engineering, and support functions within the API facility, and to all training sessions related to GMP, SOPs, equipment handling, and regulatory requirements. It covers evaluation tools, assessments, feedback collection, and performance monitoring.

3. Responsibilities

• QA Training Coordinator: Designs and implements training effectiveness assessment tools.
• Department Heads: Ensure employees attend trainings and participate in post-training evaluations.
• QA Manager: Reviews and signs off on training effectiveness reports and ensures continuous improvement actions.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that the training system is effective, documented, reviewed periodically, and compliant with applicable GMP and regulatory guidelines.

5. Procedure

5.1 Training Programs Covered

1. The QA department shall assess the effectiveness of training in the following areas:
   • GMP Induction and Refresher Training
   • SOP-specific Training
   • Technical Training on Equipment and Process
   • Change Control, Deviation, and CAPA Handling
   • Audit Readiness

5.2 Evaluation Methods

1. Training effectiveness shall be assessed through the following tools (refer Annexure-1):
   • Written Tests (Multiple Choice / True-False / Descriptive)
   • Practical Demonstration Evaluation
   • Oral Questionnaires / Interviews
   • Post-Training Observation

5.3 Scoring Criteria and Grading

1. The standard grading system shall be used:
   • Excellent: 90 – 100%
   • Good: 75 – 89%
   • Average: 60 – 74%
   • Poor: Below 60% (Requires Retraining)
2. Scores and grading shall be recorded in the Training Effectiveness Evaluation Sheet (Annexure-2).

5.4 Observation-Based Assessment

1. Post-training observations shall be conducted to verify application of learned knowledge on the shop floor using the On-Job Observation Checklist (Annexure-3).
2. Observations include:
   • GMP behavior
   • SOP compliance during operations
   • Correct use of equipment

5.5 Retraining and Follow-Up

1. Personnel scoring < 60% or showing poor compliance shall be re-scheduled for the same training within 10 working days.
2. Retraining records shall be updated in the Training Calendar & Tracker (Annexure-4).

5.6 Reporting and Trending

1. QA shall prepare a quarterly report using the Training Effectiveness Summary Report (Annexure-5), containing:
   • Total number of employees trained
   • Effectiveness score distribution
   • Retraining count and trends
2. Reports shall be reviewed during internal quality review meetings and management review meetings.

5.7 Record Retention

1. All training effectiveness records shall be retained for a minimum period of 5 years or as per regulatory requirement.

6. Abbreviations

• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Training Evaluation Questionnaire (Annexure-1)
2. Training Effectiveness Evaluation Sheet (Annexure-2)
3. On-Job Observation Checklist (Annexure-3)
4. Training Calendar & Tracker (Annexure-4)
5. Training Effectiveness Summary Report (Annexure-5)

8. References

• ICH Q10 – Pharmaceutical Quality System
• EU GMP Chapter 2 – Personnel
• 21 CFR Part 211.25 – Personnel Qualifications
• WHO TRS 986 Annex 2 – GMP Guidelines

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 Evaluation Questionnaire

Question	Options
What is the first step in deviation handling?	A) Close the batch B) Inform QA C) Skip recording D) Continue process

Annexure-2: Training Effectiveness Evaluation Sheet

Employee Name	Department	Training Title	Score (%)	Grade
Rajesh Kumar	Production	SOP on Granulation	78	Good

Annexure-3: On-Job Observation Checklist

Parameter	Compliant (Yes/No)	Remarks
Wears PPE correctly	Yes	—
Handles equipment as per SOP	No	Requires retraining

Annexure-4: Training Calendar & Tracker

Month	Topic	Scheduled Date	Trainer	Status
April 2025	SOP Writing	10/04/2025	QA Executive	Completed

Annexure-5: Training Effectiveness Summary Report

Month	Employees Trained	Excellent	Good	Average	Poor
March 2025	50	12	30	6	2

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
14/04/2025	2.0	Added scoring system and retraining process	Internal Audit Feedback	QA Head