Felix Krumbein
Head ECA Visual Inspection Group
Referent:innen
Dr. Helmut Gaus
WinSol
Christof Langer
OSConsulting
Dr. Daniel Müller
GMP Inspector
Dr Philip Hörsch
Vetter Pharma-Fertigung
Zielsetzung
Main topic of this conference is the detection of defects like particles in injectables and their evaluation. 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 and trending.
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.
In Europe the new chapter 5.17.2 of the European Pharmacopoeia now also gives further advice. However, many questions remain, e.g. concerning training, 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 (EU & US)
- How to comply with FDA’s new guidance on Visual Inspection
- Compliance with the new EU Annex 1
- Training and qualification of operators in the Manual inspection
- Validation and operation of an automated inspection System
- Reduction of false rejects in automated inspection Systems
- Correct AQL testing as part of the batch release
- How to transfer a visual inspection process during a site Change
- Special aspects of visual inspection in the production of clinical trials
Zielgruppe
This course is directed at staff from sterile operations, that is production, quality operations and engineering. But also suppliers of primary packaging materials and inspections Technology are target group of this Event.
Programm
Gesamtes Programm als PDF herunterladen
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 I
- Risk management considerations
FDA’s new Guidance on Visual Inspection
- The reason for the FDA’s Visible Particulate Guidance - visual inspection compendial requirements vs. U.S. current good manufacturing practice
- The use of quality risk management for the prevention of visible particulate contamination
- A lifecycle approach to visible particulate contamination Control
- Difference between current FDA and EU requirements
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
Particle Lifecycle Concept
- What does it tell about the product?
- What can we learn about the visual inspection process and operator qualification?
- How to implement?
Visual Inspection of parenterals - a GMP inspector‘s view
- Applicable regulations & guidance
- Current requirements for pharmaceutical Industry
- Expectations of a GMP-Inspector
- Examples of observations
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
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
Automated Visual Inspection – from Setup to Routine Use
- Different use of the three inspection systems: manual, semi-automated and fully automated inspection
- 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
Transfer of a Visual Inspection Process
- Manual inspection
- Manual process to manual process (same manufacturing location)
- Manual process to manual process (different manufacturing location)
- Test set transfer?
- Create new test set? How, why?
- What does validation look like?
- End goals and success (what are we trying to achieve?)
- Automated inspection
- Automated transfer: same machine (pitfalls)
- Automated transfer: different machine (pitfalls)
- End goals and success (what are we trying to achieve?)
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