Dr Helmut Gaus, WinSol, previously Boehringer Ingelheim
Dr Tobias Posset, Roche Diagnostics
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. This covers the following aspects of visual inspection: organisation, validation, conduct and evaluation of the results. You will also learn how to implement an automated system on the basis of manual inspection.
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. 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 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 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 (draft)
- Training and qualification of operators in the manual inspection
- Validation and operation of an automated inspection system
- Setup of test kits for training, qualification and routine inspection
- Trending and monitoring of visual inspection data
- Correct AQL testing as part of the batch release
- Re-inspection of defect fractions
This one-day training is directed at 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.
For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
- 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
From Manual to Automated 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
- Routine inspection
- Trending of inspection data
- AQL testing as part of the release process
- Impact of visual inspection data on batch release