Martin Dearden, ECA Visual Inspection Group
Dr Helmut Gaus, ECA Visual Inspection Group
Dr Philip Hörsch, Vetter Pharma-Fertigung
Felix Krumbein, Head ECA Visual Inspection Group
Christof Langer, OSConsulting
Dr Stephen Langille, formerly FDA
Dr Daniel Müller, GMP-Inspector
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.
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
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.