Standard Operating Procedure for Training and Competency

1) Purpose

The purpose of this SOP is to establish a procedure for training and assessing the competency of personnel to ensure they have the necessary knowledge and skills to perform their duties effectively and comply with regulatory requirements.

2) Scope

This SOP applies to all personnel within the manufacturing facility.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Training Coordinator:

Responsible for developing and coordinating training programs.

3.2 Department Managers:

Responsible for ensuring their personnel receive appropriate training and maintain competency.

3.3 Quality Assurance (QA) Manager:

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

4) Procedure

4.1 Training Needs Assessment:

4.1.1 Conduct a training needs assessment to identify required training for each role.
4.1.2 Document the training needs assessment.

4.2 Development of Training Programs:

4.2.1 Develop training programs based on the identified training needs.
4.2.2 Ensure training programs cover relevant procedures, regulatory requirements, and best practices.
4.2.3 Document the training programs.

4.3 Delivery of Training:

4.3.1 Deliver training programs using appropriate methods (e.g., classroom training, on-the-job training, e-learning).
4.3.2 Ensure all training sessions are conducted by qualified trainers.
4.3.3 Document attendance and completion of training sessions.

4.4 Assessment of Competency:

4.4.1 Assess the competency of personnel through tests, practical evaluations, and performance reviews.
4.4.2 Document the results of competency assessments.
4.4.3 Provide additional training or support for personnel who do not meet competency standards.

4.5 Documentation and Review:

4.5.1 Document all training activities, including training needs assessments, training programs, and competency assessments.
4.5.2 Review training records regularly to ensure ongoing compliance.
4.5.3 Update training programs and assessments as needed based on changes in procedures or regulatory requirements.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Training Needs Assessment Forms
2. Training Programs
3. Training Attendance Records
4. Competency Assessment Records

7) Reference, if any

1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ICH Q10 Pharmaceutical Quality System

8) SOP Version

Version 1.0