Standard Operating Procedure for Employee Training and Qualification

1) Purpose

The purpose of this SOP is to establish a procedure for training and qualifying personnel to ensure they are competent to perform their assigned duties in compliance with regulatory requirements and company standards.

2) Scope

This SOP applies to all new and existing employees, contractors, and temporary staff involved in the manufacturing, quality control, and quality assurance processes within the organization.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Human Resources (HR) Department:

Responsible for coordinating and documenting all training activities.

3.2 Department Managers:

Responsible for identifying training needs and ensuring their staff are adequately trained.

3.3 Quality Assurance (QA) Manager:

Responsible for overseeing the training program and ensuring compliance with GMP requirements.

3.4 All Employees:

Responsible for participating in required training and applying the knowledge gained to their work.

4) Procedure

4.1 Training Program Development:

4.1.1 Identify training needs based on job roles and responsibilities.
4.1.2 Develop a training program that includes initial training for new hires and ongoing training for existing staff.
4.1.3 Ensure the training program covers GMP, SOPs, safety procedures, and job-specific skills.

4.2 Conducting Training:

4.2.1 Schedule and conduct training sessions, including classroom instruction, hands-on practice, and assessments.
4.2.2 Use qualified trainers with expertise in the relevant subject matter.
4.2.3 Provide training materials, including manuals, presentations, and videos, to support learning.

4.3 Training Evaluation and Qualification:

4.3.1 Evaluate the effectiveness of training through written tests, practical demonstrations, and performance evaluations.
4.3.2 Document the results of training evaluations and issue qualification certificates to employees who successfully complete the training.
4.3.3 Address any gaps in knowledge or skills through additional training or remediation.

4.4 Record Keeping:

4.4.1 Maintain training records for each employee, including training dates, topics covered, evaluation results, and qualification status.
4.4.2 Store training records in a secure and easily accessible manner.
4.4.3 Update training records as needed to reflect ongoing training and requalification activities.

5) Abbreviations, if any

HR – Human Resources
QA – Quality Assurance
GMP – Good Manufacturing Practices
SOP – Standard Operating Procedure

6) Documents, if any

1. Training Program Outline
2. Training Attendance Sheets
3. Training Evaluation Forms
4. Employee Training Records

7) Reference, if any

1. FDA Guidance on Training Requirements
2. ICH Q10 Pharmaceutical Quality System

8) SOP Version

Version 1.0