Training – Standard Operating Procedure

1) Purpose

To establish guidelines for the development, implementation, and evaluation of training programs to ensure competency and compliance within the pharmaceutical manufacturing department.

2) Scope

This SOP applies to all training activities conducted for personnel involved in the manufacture, testing, and distribution of pharmaceutical products.

3) Responsibilities

Human Resources Department: Responsible for coordinating and overseeing training activities.
Department Managers: Responsible for identifying training needs and ensuring participation of their staff.

4) Procedure

4.1) Training Needs Assessment:
4.1.1) Identify training needs based on job roles, responsibilities, and regulatory requirements.
4.1.2) Conduct skills assessments and gap analyses to determine training priorities.

4.2) Training Program Development:
4.2.1) Develop training programs and curricula based on identified needs and objectives.
4.2.2) Include content on relevant procedures, regulations, and job-specific skills.

4.3) Training Delivery:
4.3.1) Deliver training through workshops, seminars, e-learning modules, or on-the-job training.
4.3.2) Ensure trainers are qualified and competent to deliver training content effectively.

4.4) Training Evaluation:
4.4.1) Evaluate training effectiveness through assessments, quizzes, or practical demonstrations.
4.4.2) Solicit feedback from trainees to identify areas for improvement in training programs.

4.5) Training Records: