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 |