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:
4.5.1) Maintain accurate records of training sessions attended, completed, and results achieved.
4.5.2) Document training completion and competency assessments for personnel records.
4.6) Continuous Improvement:
4.6.1) Review and update training programs periodically to reflect changes in procedures, regulations, or job requirements.
4.6.2) Implement corrective actions based on training evaluation results and feedback.
5) Abbreviations, if any
N/A
6) Documents, if any
- Training Needs Assessment Reports
- Training Program Outlines
- Training Attendance Records
- Training Evaluation Forms
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.25, ICH Q10
Industry Standards: ISO 13485:2016
8) SOP Version
Version 1.0