Standard Operating Procedure for Aseptic Technique Training

1) Purpose

This SOP outlines the procedures for training personnel in aseptic techniques to maintain sterility and minimize contamination risks during pharmaceutical manufacturing.

2) Scope

This SOP applies to all personnel involved in aseptic operations within the pharmaceutical manufacturing facility.

3) Responsibilities

The Training department is responsible for conducting aseptic technique training sessions. Quality Assurance (QA) ensures the training program complies with this SOP and regulatory requirements.

4) Procedure

4.1 Training Program Development

1. Develop a comprehensive aseptic technique training program that covers fundamental principles, techniques, and regulatory requirements.
2. Include practical exercises and assessments to reinforce learning outcomes.

4.2 Training Content

1. Outline the importance of maintaining sterility in aseptic operations and the consequences of contamination.
2. Detail proper gowning procedures, hand hygiene practices, and environmental monitoring requirements.
3. Incorporate specific techniques for aseptic manipulations, such as vial handling, component assembly, and filling operations.

4.3 Training Delivery

1. Conduct training sessions in dedicated training rooms or simulated environments that replicate cleanroom conditions.
2. Use visual aids, demonstrations, and interactive methods to engage participants and enhance learning.

4.4 Competency Assessment

1. Evaluate trainee competency through practical assessments and written tests to ensure understanding and proficiency in aseptic techniques.
2. Provide feedback and additional training as needed to address areas requiring improvement.

4.5 Refresher Training

1. Offer periodic refresher training sessions to reinforce aseptic technique principles and update personnel on new regulations or best practices.
2. Maintain records of training attendance, assessments, and competency evaluations.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Aseptic Technique Training Program, Training Records, Competency Assessment Reports

7) Reference, if any

Regulatory guidelines such as 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