Procedure for Documenting Training Records for Personnel

Department	Human Resources (HR)/Quality Assurance (QA)/Training & Development
SOP No.	SOP/Ointment/166
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized process for documenting training records of personnel in pharmaceutical manufacturing. Accurate training records ensure regulatory compliance, competency verification, and continual professional development.

2. Scope

This SOP applies to all personnel in Human Resources (HR), Quality Assurance (QA), Training & Development, and other departments involved in conducting, monitoring, and documenting training sessions.

3. Responsibilities

• Training Coordinator: Organizes training programs and maintains training records.
• QA Officer: Verifies training records for regulatory compliance.
• HR Representative: Ensures personnel files are updated with training records.
• Department Heads: Identify training needs for their teams.
• QA Manager: Approves training programs and verifies competency assessments.

4. Accountability

The QA and HR Managers are accountable for ensuring that all training records are properly documented and maintained in compliance with GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Types of Training to be Documented

All training sessions conducted for employees must be documented. These include:

• GMP and Regulatory Training: Covers guidelines from FDA, WHO, ICH, and GMP.
• SOP Training: Training on newly introduced or revised SOPs.
• On-the-Job Training (OJT): Hands-on training for new equipment, procedures, and systems.
• Quality and Compliance Training: Focuses on deviation management, CAPA, and audits.
• Health & Safety Training: Includes workplace safety, handling hazardous materials, and emergency procedures.
• Annual Refresher Training: Ensures continuous competency of employees.

5.2 Conducting and Documenting Training

• Each training session must be **scheduled in advance** and approved by the QA Manager.
• A **Training Attendance Sheet (Annexure-1)** must be maintained for every session.
• Training records must include:
  • Training date and duration.
  • Trainer’s name and designation.
  • List of trainees.
  • Training content and objectives.
  • Assessment method (if applicable).
  • Trainee feedback and trainer’s remarks.
• For **SOP Training**, trainees must sign the **SOP Acknowledgment Form (Annexure-2)** after completing the training.

5.3 Competency Assessment and Evaluation

• All training sessions must have an **assessment component** to verify understanding.
• Assessment methods may include:
  • Written quizzes or multiple-choice tests.
  • Practical demonstrations.
  • Case study analysis.
• A minimum **passing score of 80%** is required for GMP and compliance training.
• Employees failing an assessment must undergo **retraining** within **30 days.**

5.4 Filing and Maintaining Training Records

• All training records must be filed in **individual employee training files**.
• Paper-based records must be stored in a **secured archive**.
• Electronic training records must be stored in the **Learning Management System (LMS)**.
• Training records must be labeled with:
  • Employee name and ID.
  • Training module and completion date.
  • Trainer’s approval.

5.5 Periodic Review and Audit of Training Records

• HR and QA must conduct **quarterly reviews** of training records.
• Training compliance audits must be performed **annually**.
• Any gaps in training documentation must be **corrected within 15 days.**

5.6 Retention Period of Training Records

• Training records must be archived for **a minimum of 5 years**.
• Electronic backups must be performed **monthly**.
• Records must be **accessible for regulatory inspections and audits.**

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• HR – Human Resources
• LMS – Learning Management System
• SOP – Standard Operating Procedure
• OJT – On-the-Job Training
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Training Attendance Sheet (Annexure-1)
• SOP Acknowledgment Form (Annexure-2)

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Guidelines on Personnel Training
• US FDA Guidance on Training Compliance

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 Attendance Sheet

Date	Training Topic	Trainer	Employee Name	Signature
02/02/2025	GMP Compliance	John Doe	Jane Smith	Signed

Annexure-2: SOP Acknowledgment Form

Employee Name	Employee ID	SOP No.	Training Date	Trainer Signature
Jane Smith	EMP-1001	SOP-002	02/02/2025	John Doe

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Training Review Process	Improved Compliance	QA Head