Regulatory Requirements for the Visual Inspection of Parenterals
- Compendial Requirements
- 100% visual inspection & AQL testing
- PharmEur, USP, JP - similarities and differences
- News from the Annex 1 revison
- Risk Management Considerations
Expectations of a GMP Inspector regarding Visual Inspection
- Regulatory documents on visual inspection of parenterals (an overview)
- Manual inspection, semi-automated inspection (personnel, working place, equipment, training & qualification)
- Automated inspection (incl. validation strategy)
- Routine operations, AQL testing, handling of (r)ejects
- Inspection findings & experience
Manual Visual Inspection – Theory and Practical Aspects
- Probabalistic nature of visual inspection
- Defect categorisation
- Differentiation of test kits for training, qualification and routine
- Qualification and training of personnel
- Standardisation of working conditions in Manual inspection
- Usage of the Knapp and the modified Knapp test
Automated Visual Inspection – from Setup to Routine Use
- Limitations of automated inspection
- Setting up a qualification strategy for automated systems
- Cross validation during the PQ phase of an automated system
- Importance of particle detection rates
- System suitability, requalification and revalidation
- Inspection of eject fractions
- The Roche Inspection systems: manual, semi-automated and fully automated inspection
Requirements, Composition, and Handling of
- Test Sets
- Definition of defect categories
- Set-up and composition of a test set
- Test sets and their use for training, qualification and routine
- Handling and release of test sets
- Documentation
Handling Inherent Particulate Matter of Biologics
- in Visual Inspection
- Challenge of inherent particulate matter in drug product solution
- Appearance and characteristics of inherent particulate matter
- Impact on visual inspection
- Handling inherent particulate matter in routine visual inspection
- Establishment of a life-cycle management approach
Re-Inspection of Defect Fractions in
- Visual Inspection
- Different scenarios will be covered such as:
- Re-inspection or additional inspection of “grey-channel” units from (semi-) automated inspection
- Re-inspection in case of exceeding alert limits or
- AQL failures
- Focused re-inspection
- Inspection approaches in case of investigations due to unexpected particles (e.g., to determine frequency of occurrence of visible particles when particles are found during release/stability testing
Automated Visual Inspection Based on Unsupervised Machine Learning
- Vector segmentation using unsupervised machine learning
- Characterizing variation using computer vision
- Learning normal variation in defect-free bottles
- Visual inspection via anomaly detection
Particle Testing and the Correlation with Trending and Batch Release
- Why do we Monitor (What is it all about)
- Data and measurement
- The AQL trap
- Improvement process map
- Investigation and routine analysis,
- Release Process. “To AQL or not to AQL that is the Question”
- Product release: “Falling off a log”