Dr Helmut Gaus, WinSol, previously Boehringer Ingelheim
This training course gives you an understanding of the fundamentals of visual inspection applicable to the manual inspection of injectable products. This covers the following aspects of visual inspection: organisation, training, qualification and the inspection process itself. You will also learn about AQL testing and trending of inspection data.
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 of 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, qualification, detection capabilities and Organisation of the visual inspection and the AQL testing.
- 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
- Setup of test kits for training and qualification
- 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 manual 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.
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- Requirements of the different Pharmacopeia
- Defect categorisation
- Test kits for training, qualification and routine
- Organisation of the manual inspection
- Qualification of personnel
- Training of personnel
- Standardisation of working conditions
- AQL in the manual inspection
- Trending of inspection data & batch release
Recording from 28 June 2022
Duration of the recording: approx. 1,5 h