Standard Operating Procedure for IPC Training to Operators and Chemists in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/102/2025
Supersedes	SOP/API/102/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define the procedure for conducting systematic training for production operators and chemists on In-Process Control (IPC) practices relevant to API manufacturing, ensuring understanding and compliance with cGMP requirements.

2. Scope

This SOP applies to all new and existing operators and chemists engaged in the execution, supervision, and documentation of IPC checks during API batch processing.

3. Responsibilities

• QA Officer: Prepare and approve training materials and ensure training records are maintained.
• Production/QA Trainer: Conduct classroom and on-the-job training sessions for IPC procedures.
• Line Manager: Ensure that personnel attend training and are assessed before deployment.
• Trainee (Operator or Chemist): Actively participate in training, seek clarifications, and demonstrate competence during assessment.

4. Accountability

The QA Head is accountable for overseeing the IPC training program. The Production Head is accountable for ensuring that only trained personnel perform IPC activities.

5. Procedure

5.1 Training Needs Identification

1. Identify training requirements for new joinees, role changes, or updates to IPC SOPs.
2. Prepare a monthly IPC training calendar and circulate to Production and QC.
3. Topics shall include:
   • Introduction to IPC
   • GMP principles for IPC documentation
   • Stage-wise IPC checks (e.g., pH, LOD, yield, color, crystal size)
   • Sampling techniques
   • Use of IPC equipment (e.g., IR balance, pH meter)

5.2 Training Methods

1. Conduct sessions through a mix of:
   • Classroom training with presentations and SOP reviews
   • Hands-on training during batch execution under supervision
   • Demonstration of documentation practices in IPC logbooks

5.3 Training Material

1. Prepare training material approved by QA, including:
   • Copy of SOPs
   • Visual aids showing correct and incorrect practices
   • Short tests for post-training evaluation

5.4 Evaluation and Certification

1. Conduct a written or oral assessment post-training using a pre-approved questionnaire (Annexure-1).
2. Minimum passing score shall be 80%.
3. Personnel failing the assessment shall undergo retraining before reassessment.
4. Maintain individual training records (Annexure-2) in QA-controlled files.
5. Issue training completion certificates signed by QA and department head.

5.5 Refresher and Annual Training

1. Conduct annual refresher training on IPC practices for all staff involved in manufacturing.
2. Update staff promptly on any procedural changes or regulatory updates.

5.6 Documentation

1. Maintain the following records:
   • Training attendance sheet
   • Evaluation sheet
   • Training summary report
   • Signed IPC SOP acknowledgement forms

6. Abbreviations

• SOP: Standard Operating Procedure
• IPC: In-Process Control
• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice

7. Documents

1. IPC Training Evaluation Sheet (Annexure-1)
2. Training Record Form (Annexure-2)
3. Training Calendar
4. Training Acknowledgement Log

8. References

• ICH Q7 – GMP for APIs
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• 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: IPC Training Evaluation Sheet

Employee Name	Department	Test Date	Total Score	Result	Trainer Initial	Remarks
Ravi Kumar	Production	10/04/2025	18/20	Pass		Certified

Annexure-2: IPC Training Record Form

Employee Name	Designation	Training Topic	Date	Trainer	Signature
Sunita Reddy	Chemist	IPC Sampling and LOD Testing	09/04/2025	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New Training SOP	QA Head
13/04/2025	2.0	Added evaluation method and certification step	Audit Enhancement	QA Head