other GMP-influencing functions at the API manufacturing site. It includes induction, periodic, refresher, and need-based training activities.

3. Responsibilities

• HR Department: Coordinates induction training and maintains employee training records.
• QA Department: Prepares and updates GMP training material, schedules GMP sessions, conducts or facilitates training, and assesses effectiveness.
• Department Heads: Identify training needs and ensure attendance of their team members.
• Employees: Actively participate in training sessions and assessments.

4. Accountability

The QA Head is accountable for ensuring that GMP training content is current, accurate, and effectively delivered and that all training records are maintained in compliance with regulatory requirements.

5. Procedure

5.1 Training Types

1. Induction Training: For all new employees before starting GMP-related work.
2. Periodic Training: Conducted quarterly and annually based on a pre-approved calendar.
3. Refresher Training: Conducted to reinforce critical GMP concepts.
4. Need-Based Training: Triggered by deviations, audit findings, procedural changes, or new equipment introduction.

5.2 Training Content Design

1. QA prepares training modules using multiple formats such as:
   • PowerPoint presentations
   • Workshops and group exercises
   • SOP walkthroughs
   • Videos and e-learning (if applicable)
2. Topics include but are not limited to:
   • GMP principles and regulations (ICH, WHO, FDA, EU)
   • Data integrity and ALCOA+
   • Deviation, CAPA, and change control
   • Hygiene, gowning, and contamination control
   • SOP compliance and documentation practices
3. Training content is reviewed and approved by QA Head before use.

5.3 Training Calendar

1. QA prepares an annual GMP training calendar (Annexure-1).
2. All sessions are scheduled and communicated to respective department heads at least one month in advance.

5.4 Training Delivery

1. Training may be delivered:
   • In-person (classroom sessions)
   • On-the-job with demonstrations
   • Via video conferencing or digital platforms
2. Attendance shall be documented in the Training Attendance Sheet (Annexure-2).
3. Trainer must be qualified in the subject area.

5.5 Training Assessment and Effectiveness Check

1. Post-training assessments shall be conducted using:
   • Multiple choice or written test
   • Verbal questioning
   • Practical demonstration
2. A minimum score of 80% is required to be deemed successful (unless otherwise specified).
3. Assessment records are maintained in the Training Evaluation Log (Annexure-3).
4. For employees scoring below threshold, retraining shall be scheduled within 2 weeks.

5.6 Training Records and Archival

1. All training-related documents shall be filed in the respective employee’s Training File and centrally archived by QA.
2. A Training Matrix for each department shall be maintained and updated monthly (Annexure-4).
3. Records shall be retained for at least 5 years or as per local regulatory requirements.

5.7 Training Program Review

1. QA shall perform periodic reviews of training effectiveness using:
   • Audit findings
   • Deviation trends
   • Assessment scores
2. Training programs shall be revised or enhanced based on feedback and review outcomes.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• SOP: Standard Operating Procedure
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available

7. Documents

1. Annual Training Calendar (Annexure-1)
2. Training Attendance Sheet (Annexure-2)
3. Training Evaluation Log (Annexure-3)
4. Department-wise Training Matrix (Annexure-4)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211.25 – Personnel Qualifications
• EU GMP Chapter 2 – Personnel

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Annual GMP Training Calendar

Month	Topic	Trainer	Department
January	Data Integrity	QA Officer	All
April	Deviation and CAPA	QA Manager	Production & QA

Annexure-2: Training Attendance Sheet

Name	Department	Date	Signature
Sunita Reddy	QA	10/04/2025
Rajesh Kumar	Production	10/04/2025

Annexure-3: Training Evaluation Log

Name	Score (%)	Pass/Fail	Remarks
Sunita Reddy	90	Pass	Good understanding
Rajesh Kumar	75	Fail	To be retrained

Annexure-4: Department-wise Training Matrix

Employee Name	Induction	Data Integrity	Deviation	CAPA
Rajesh Kumar	✓	✓	✓	Pending
Sunita Reddy	✓	✓	✓	✓

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Issue	New Document	QA Head
14/04/2025	2.0	Added new annexures and assessment criteria	Improved regulatory alignment	QA Head