Visual Inspection Systems
Im Auftrag der ECA Academy

Visual Inspection Systems Im Auftrag der ECA Academy

Vienna, Austria

Seminar Nr. 16878


Kosten

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

Sprecher

Dr Martin Becker, Siegfried Hameln
Dr Helmut Gaus, Winsol, previously  Boehringer Ingelheim
Felix Krumbein, Roche
Christof Langer,  OSConsulting
Dr Tobias Posset, Roche
Dr Bernd Renger, Immediate Past Chair of the European QP Association

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
  •  Training in the manual visual inspection
  •  Qualification 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
  •  Root cause analysis in case of particulate matter

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
  • GMP Expectations
    • Manual inspection
    • Automated Inspection
  • Risk Management Considerations
Fundamentals of Visual Inspection – Theory and practical aspects
  • Probabalistic nature of visual inspection
  • Defect categorisation
  • Test kits for training, qualification and Routine
  • Qualification and training of personnel
  • Standardisation of working conditions in the manual inspection
  • Usage of the Knapp and the modified Knapp test
  • AQL testing in the process of visual inspection
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
Particulate Matter: Origins and Root Cause Analysis
  •  External sources (packaging material, filter, abrasion..)
  •  Internal sources (product and inherent particles)
  •  Potential risks for patients
  •  Route cause detection and particle identification
  •  Avoidance and depletion of particles
Reinspection 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)
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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