SOP for Employee Training and Competency Development

Standard Operating Procedure for Employee Training and Competency Development

1) Purpose

This SOP outlines the procedures for training and competency development for employees working in GMP-regulated areas. Proper training ensures that employees are knowledgeable about GMP requirements, their roles, and responsibilities.

2) Scope

This SOP applies to all employees working in GMP-regulated production and quality control areas at [Company Name].

3) Responsibilities

Training Manager: Responsible for organizing and scheduling employee training programs.
Supervisors: Ensure employees have completed required training before performing their roles and assess employee competency periodically.
Quality Assurance (QA): Verifies that training records are accurate and compliant with GMP regulations.

4) Procedure

4.1 Training Program Setup

4.1.1 Identifying Training Needs

Conduct a needs assessment to identify required training for all roles in GMP areas, including new hires and existing staff. Ensure that training covers relevant SOPs, GMP principles, safety protocols, and job-specific tasks.

4.1.2 Scheduling Training

Develop a training schedule that covers both initial and ongoing training sessions. All new hires must complete initial training before they begin working in GMP areas.
Ensure ongoing GMP and role-specific training sessions are conducted at

least once every six months.

4.2 Conducting Training Sessions

4.2.1 Training Content

Training sessions should cover:
- GMP principles and regulatory requirements.
- Personal hygiene and cleanroom entry/exit procedures.
- Handling of hazardous chemicals and safety protocols.
- Job-specific tasks and procedures, including SOP compliance.
Provide training materials, such as handouts, videos, and practical demonstrations to reinforce learning.

4.2.2 Competency Assessment

Assess employee competency through written tests, practical demonstrations, and on-the-job evaluations. Employees must demonstrate competency in their roles before being authorized to work independently in GMP areas.
Document all assessments and retain records in the employee training log.

4.3 Post-Training Activities

4.3.1 Recordkeeping

Document the completion of all training sessions and competency assessments in the employee training log. Include the employee’s name, training date, topics covered, and the trainer’s initials.
Submit training records to QA for review and retention as per GMP documentation requirements.

4.3.2 Training Feedback and Improvement

Collect feedback from employees on the effectiveness of the training program. Use the feedback to identify areas for improvement in future training sessions.
QA and supervisors must review training feedback and incorporate necessary changes to the training program.

5) Abbreviations, if any

GMP: Good Manufacturing Practices
QA: Quality Assurance

6) Documents, if any

Employee Training Log
Competency Assessment Form

7) References, if any

Internal SOP for employee development and training

8) SOP Version

Version 1.0

Annexure

1. Employee Training Log Template


  
    Employee Name
    Employee ID
    Training Date
    Training Topics
    Trainer Initials
    QA Approval
  
  
    Employee Name
    Employee ID
    DD/MM/YYYY
    Topics Covered
    Trainer Name
    QA Name