Project
Improving Personnel Aseptic Behaviour involved in the aseptic manufacturing processes
Problem Statment
- High reoccurrence of microbiological
excursion related to the human origin
microorganisms
- Batches rejection due to microbiological excursion
- Batches rejection due to microbiological excursion
Analysed elements
- New Training needs analysis
- Microbiological excursions analysis
- Quality Oversight trend analysis
- Microbiological excursions analysis
- Quality Oversight trend analysis
Identified Root Cause
- Lack of understanding of the impact of correct aseptic behaviour and
potential products risk contamination (SQE) and impact on the patiences
- Poor quality oversights by both Production and Quality people during aseptic operations
- Poor quality oversights by both Production and Quality people during aseptic operations
Proposed Solutions
- Develop a Training program to provide the WHY and the HOW to perform
the correct aseptic behaviour to all people involved in the aseptic activities
- Design of a training program based on both classroom (theory) and shoop floor (practice) sessions for people involved in quality oversights activities
- Design of a training program based on both classroom (theory) and shoop floor (practice) sessions for people involved in quality oversights activities
Opportunity and Benefits
1. Increased robustness of personnel Aseptic Behaviour performance
2. Quality Oversight checklist improvement
3. Reduced deviations reoccurrence rate
4. Reduced investigations resource requirement
5. Improved cycle time for the batch release process