Standard Operating Procedure for Training of Personnel in Aseptic Manufacturing
1) Purpose
The purpose of this SOP is to establish procedures for the training and qualification of personnel involved in aseptic manufacturing processes to ensure competency and adherence to aseptic techniques.
2) Scope
This SOP applies to all personnel engaged in aseptic manufacturing operations within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Human Resources (HR) Department
- Develop and implement training programs for aseptic manufacturing personnel.
- Maintain training records and competency assessments.
3.2 Production Supervisors
- Provide on-the-job training and supervision for new personnel.
- Monitor and evaluate the performance of trained personnel.
4) Procedure
4.1 Training Program Development
- Identify training needs based on job roles and responsibilities.
- Develop training modules covering aseptic techniques, gowning, and hygiene practices.
4.2 Training Delivery
- Conduct initial training sessions for new hires and refresher courses for existing personnel.
- Provide hands-on training in cleanroom environments under supervision.
4.3 Competency Assessment
- Evaluate trainees’ understanding and proficiency in aseptic practices through written tests and practical assessments.
- Document and maintain records of training completion and competency assessments.
4.4 Training Effectiveness Review
- Monitor the application of learned skills and behaviors in daily manufacturing operations.
- Implement corrective actions and additional training as needed based on performance reviews and audits.
5) Abbreviations, if any
SOP: Standard Operating Procedure; HR: Human Resources
6) Documents, if any
- Training Needs Assessment Report
- Training Modules and Materials
- Training Records and Competency Assessment Forms
7) Reference, if any
EU GMP Annex 1: Manufacture of Sterile Medicinal Products
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
8) SOP Version
Version 1.0