Sprecher
Dr Helmut Gaus, formerly Boehringer Ingelheim
Dr Tobias Posset, Roche
Zielsetzung
The training course on visual inspection gives you an understanding of the fundamentals of visual inspection of injectable products, applicable to manual and automated inspection. You will also learn how to implement an automated system on the basis of manual inspection.
Hintergrund
The 100% visual inspection of sterile injectable products is a requirement originating from the Pharmacopoeias, e.g. from the US USP or the European PharmEur. But 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. However, many questions remain, e.g. concerning re-testing, detection capabilities and revalidation of inspection systems.
Furthermore, there has been a recognisable trend towards automated inspection machines in 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 questions also arise during routine processes like, for example re-testing and the usage of test-sets, doing AQL-Testing as well as the adjustment of parameters of the vision systems.
Due to the lack of precise requirements the ECA Visual Inspection Group has developed a Best Practice Guidance. This paper is very helpful during daily business and answers many questions in its chapters:
- Automated inspection
- Manual inspection
- Inspection of lyophilized product
- Defect classes
- Evaluation of defect classes and trending
- Batch release
The course also includes an AQL training, meaning that you will learn how to use AQL tables to set defect limits and how to evaluate batch inspection data. For that purpose all participants of the Pre-Conference Course receive the AQL Inspector’s Rule as tool for AQL testing for free.
The rule covers a wide range of AQL's (.065 to 15) with Normal, Tightened and Reduced inspection for both single and double sampling plans according to ISO 2859-1 (1999). The practical usage of this tool will be shown during the course.
Zielgruppe
This one day course is directed t everybody involved in the 100% inspection of sterile injectables. As the fundamentals are explained in a very comprehensive way, the course is very popular with beginners and medium experienced staff.
Bonus for the participants of this course:
The AQL Inspector’s Rule - A tool for conducting AQL Testing.
Programm
Pre-Conference Course "Fundamentals of Visual Inspection & AQL Testing"
General requirements
- Requirements of the different Pharmacopeia
- Defect categorisation
- Test kits for training, qualification and routine
- Qualification of personnel
- Training of personnel
- Standardisation of working conditions
- AQL in the manual inspection
- Usage of the Knapp and the modified Knapp test
- Detection rates
- Cross validation during the PQ phase
- Importance of particle detection rates
- System-Suitability, Requalification and revalidation
- Defect and reject fractions
- AQL testing as part of the release process
- Trending of inspection data
- Impact of visual inspection data on batch release
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Tel.: +49 6221 84 44 0
Im%20Auftrag%20der%20ECA%20Academy 9 October 2018" title="E-Mail">E-Mail: info@concept-heidelberg.de
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