manufacturing facility, including formulation, filtration, filling, and sealing operations.

3. Responsibilities

• Training Coordinator: Plans and executes training sessions, maintains training records.
• Manufacturing Manager: Identifies training needs for personnel based on their roles.
• QA Representative: Verifies effectiveness of training and approves training materials.
• Employees: Attend training sessions, demonstrate understanding, and follow procedures.

4. Accountability

The Head of Manufacturing is accountable for ensuring that all personnel involved in in-process monitoring are adequately trained and periodically evaluated for competence.

5. Procedure

5.1 Training Needs Identification

1. Assess job roles in manufacturing and identify in-process activities applicable to each role.
2. Develop a training matrix specifying required skills such as weight checks, pH measurement, filling volume verification, visual inspection, etc.
3. Update the matrix annually or upon introduction of new processes.

5.2 Training Plan Preparation

1. Create a yearly training calendar covering:
   • GMP overview
   • In-process control parameters
   • Equipment operation and calibration
   • Documentation practices
   • Handling of deviations and OOS results
2. Prepare session materials including SOPs, checklists, visual aids, and case studies.

5.3 Execution of Training

1. Conduct training sessions in small batches for effective engagement and Q&A.
2. Use real-life examples and demonstration of techniques in the production area or via video simulation.
3. Hands-on demonstration of monitoring activities under supervision.

5.4 Evaluation of Training Effectiveness

1. Conduct written and/or practical tests after training sessions.
2. Record scores and observations in the Training Evaluation Record (Annexure-1).
3. Retrain personnel with inadequate performance scores (less than 80%).

5.5 Qualification and Authorization

1. Personnel scoring 80% or above are qualified and listed in the Authorized Personnel Register (Annexure-2).
2. Issue authorization letters signed by QA and Manufacturing Heads.

5.6 Retraining and Continuous Learning

1. Retraining shall be conducted:
   • Annually
   • After any critical deviation or GMP non-compliance
   • Upon introduction of new procedures or equipment
2. Record all retraining in the Retraining Log (Annexure-3).

5.7 Documentation

1. Maintain:
   • Training attendance sheets
   • Evaluation records
   • Certificates or letters of authorization
2. All documents must be reviewed by QA and stored in the training file for a minimum of 5 years.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• OOS: Out-of-Specification
• IPC: In-Process Control

7. Documents

1. Training Evaluation Record – Annexure-1
2. Authorized Personnel Register – Annexure-2
3. Retraining Log – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Technical Report Series 986 Annex 2 – GMP for Sterile Pharmaceutical Products
• 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	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Training Evaluation Record

Employee Name	Training Topic	Date	Score (%)	Trainer	Remarks
Rajesh Kumar	Weight Check Procedure	10/06/2025	92	Sunita Reddy	Qualified

Annexure-2: Authorized Personnel Register

Employee Name	Designation	Authorized Task	Authorization Date	Approved By
Meena Iyer	Operator	In-process Weight Check	12/06/2025	QA Head

Annexure-3: Retraining Log

Employee Name	Reason for Retraining	Retraining Date	Trainer	Remarks
Ajay Verma	Procedure change	20/06/2025	Rohit Nair	Completed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	Expanded training matrices and evaluation annexures	Annual Review	QA Head