Control of Parenterals - Visual Inspection Systems
Im Auftrag der ECA Academy

Control of Parenterals - Visual Inspection Systems Im Auftrag der ECA Academy

Barcelona, Spain

Seminar Nr. 17274

 

Kosten

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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Martin Becker, IDT Biologika
Martin Dearden, ECA Visual Inspection Group
Dr Helmut Gaus, WinSol, previously Boehringer Ingelheim
Felix Krumbein, Roche
Christof Langer, OSConsulting
Dr Daniel Müller, GMP-Inspector
Dr Tobias Posset, Roche
Dr Brian Turnquist, Boon Logic
Désirée Womser, Novartis

Zielsetzung

Main topic of this course is the detection of defetcs like particles in injectables and their evaluation during batch release. Besides the current regulatory requirements with regards to particulate matter, routine 100% inspection of injectables will be addressed. Manual inspection as well as automated inspection systems will be covered, including validation, training, defect categories, AQL testing, trending and batch release considerations

Hintergrund

In most cases particles found in parenteral medicines will lead to a quarantined product or even to the recall of the product – as we have seen in the last years in the cases of several pharmaceutical companies. Responsible staff in charge will have to start root cause analysis to find the source of the particles and will have to do an evaluation of batches already shipped.

There is still confusion within the global pharmaceutical industry with regard to the requirements for testing for visible particles. After the USP chapters <790> and <1790> were published, things have become much clearer, at least for the US. But still, lots of questions arise, e.g. concerning re-testing, detection capabilities and revalidation of inspection Systems.

Furthermore there has been a recognisable trend towards automated inspection machines throughout the last years. The challenge for pharmaceutical companies is to find a suitable machine for their products and to determine reasonable inspection parameters during qualification and validation. But also during routine process there are questions arising like re-testing and the usage of test-sets, doing AQL-Testing as well as the adjustment of parameters of the vision systems.
We will address those topics during the conference and discuss and answer questions on
  •  The latest compendial requirements concerning particulate matter
  •  Compliance with the revised Annex 1
  •  Training and qualification of operators in the manual inspection
  •  Validation and operation of an automated inspection system
  •  Trending and monitoring of visual inspection data
  •  Correct AQL testing as part of the batch release
  •  Re-inspection of defect fractions
  • Usage of artificial intelligence in visual inspection

Zielgruppe

This course is directed at staff from sterile operations, that is production, quality assurance and engineering. But also suppliers of primary packaging materials and inspections technology are target group of this Event.

Best Practice Paper

All participants receive the current version of ECA’s Best Practice Paper on “Visual Inspection” for free.

Programm

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”

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