employees involved in gel production, in-process checks, and quality assurance activities within the Gel Manufacturing department.

3. Responsibilities

• HR Department: Maintain training records and coordinate induction programs.
• Department Head: Identify training needs and allocate trainers.
• Trainers: Deliver training sessions, evaluate understanding, and document performance.
• Employees: Participate actively and complete all assessments.
• QA: Audit training effectiveness and ensure compliance with regulatory expectations.

4. Accountability

The Head – Manufacturing is accountable for ensuring all personnel are adequately trained before performing independent tasks and for maintaining training effectiveness.

5. Procedure

5.1 Training Needs Identification

1. Compile a list of core competencies for each role in Gel Manufacturing and QA.
2. Identify skill gaps during performance reviews and audits.
3. Document training needs in the “Training Needs Matrix” (Annexure-1).

5.2 Induction Training

1. All new joiners shall undergo induction training covering:
   • GMP Guidelines
   • SOP Awareness
   • Hygiene and Gowning
   • Gel Manufacturing Process Overview
2. Record induction in “Induction Training Record” (Annexure-2).

5.3 On-the-Job Training (OJT)

1. Assign each trainee to a qualified trainer.
2. Conduct hands-on demonstrations of key tasks:
   • Material dispensing and handling
   • pH and viscosity testing
   • Gel mixing and homogenization
   • Equipment cleaning and maintenance
3. Evaluate trainee performance using “OJT Evaluation Form” (Annexure-3).

5.4 Refresher Training

1. Conduct annual refresher training on:
   • New/Updated SOPs
   • Critical deviations and CAPAs
   • Audit findings and lessons learned
2. Log sessions in “Refresher Training Log” (Annexure-4).

5.5 Assessment and Qualification

1. Conduct written/oral tests and practical evaluations.
2. Minimum passing criteria: 80% for theoretical and 100% compliance for practical tasks.
3. Provide feedback and retraining if performance is unsatisfactory.

5.6 Training Record Maintenance

1. All training documents to be maintained in the “Personnel Training File.”
2. Training records must be retained for minimum 5 years or as per regulatory requirements.

5.7 Training Effectiveness Monitoring

1. QA to perform periodic audits of training records and interview trained personnel.
2. Trend deficiencies and recommend improvements in the training process.

6. Abbreviations

• QA: Quality Assurance
• OJT: On-the-Job Training
• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practices

7. Documents

1. Training Needs Matrix – Annexure-1
2. Induction Training Record – Annexure-2
3. OJT Evaluation Form – Annexure-3
4. Refresher Training Log – Annexure-4

8. References

• ICH Q10: Pharmaceutical Quality System
• 21 CFR Part 211 – Current Good Manufacturing Practice
• EU GMP Guidelines Chapter 2 – Personnel

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Training Needs Matrix

Role	Skill Area	Required Level	Identified Gap	Training Planned

Annexure-2: Induction Training Record

Date	Employee Name	Topics Covered	Trainer	Remarks

Annexure-3: OJT Evaluation Form

Task	Demonstrated By	Observed By	Evaluation Result	Comments

Annexure-4: Refresher Training Log

Date	Topic	Trainer	Participants	Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial Issue	New SOP	QA Head
02/06/2025	2.0	Improved structure and annexure formatting	Review Update	QA Head