Standard Operating Procedure for Training and Competency

1) Purpose

The purpose of this SOP is to establish procedures for the training, competency assessment, and qualification of personnel to ensure competence in performing assigned tasks and responsibilities.

2) Scope

This SOP applies to all personnel within the manufacturing facility who perform activities related to manufacturing, quality control, quality assurance, and other critical functions.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Training Coordinator:

Responsible for coordinating training activities and maintaining training records.

3.2 Department Managers:

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

3.3 Quality Assurance (QA) Manager:

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

4) Procedure

4.1 Training Needs Identification:

4.1.1 Identify training needs based on job roles, responsibilities, and competency requirements.
4.1.2 Document training needs in the Training Plan.

4.2 Training Program Development:

4.2.1 Develop training programs and materials based on identified needs and regulatory requirements.
4.2.2 Obtain approval for training programs from QA and department managers.
4.2.3 Conduct periodic reviews and updates of training programs.

4.3 Training Delivery:

4.3.1 Schedule and deliver training sessions according to the Training Plan.
4.3.2 Ensure trainers are qualified and competent to deliver training.
4.3.3 Document attendance and participation in training sessions.

4.4 Competency Assessment:

4.4.1 Assess the competence of personnel through written exams, practical demonstrations, or other methods.
4.4.2 Document assessment results and determine competency status.
4.4.3 Provide feedback and additional training as necessary.

4.5 Training Records and Documentation:

4.5.1 Maintain accurate and up-to-date training records for all personnel.
4.5.2 Archive training records according to established document retention policies.
4.5.3 Provide training records during internal and regulatory audits as required.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Training Plan
2. Training Programs and Materials
3. Training Records
4. Competency Assessment Reports

7) Reference, if any

1. FDA Guidance on Training of Personnel
2. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0