Dr Tobias Posset, Roche Diagnostics
Parenterals have to be 100% visually inspected. The semi-automated visual inspection is used for liquid and lyo vials and syringes since many years. Now, this type of inspection is getting more and more into the focus of GMP regulations and regulators. The requirements for manual or automated, camera-based inspections have become much clearer during the last 2-3 years with each relevant new chapter of the US and EU Pharmacopeias. But for the semi-automated visual inspection, being a hybrid of both methods mentioned above, this is not the case. Especially when it comes to inspection time per container, necessary computer validation and eye breaks etc.
With this Webinar we want to show, how a GMP-compliant concept of a semi-automated inspection system and its qualification could look like.
The target group of this webinar are professionals in quality assurance, technology and production who are entrusted with the implementation or operation of a semi-automated inspection system or its defense during audits & inspections.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
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.
Topics in this webinar cover conception, qualification and routine use of semi-automated visual inspection of parenterals.
- Qualification concepts for semi-automated 100% visual inspection including particle detection
- Dealing with particle detection and its probabilistic nature using semi-automated visual inspection
- A particle-threshold-study vs. particle detection using fixed predefined limits
- Qualification kits and defect libraries for the different qualification concepts
- Semi-automated visual inspection in daily Business
- eye breaks
- inspection times
- number of objects to be inspected
- Semi-automated visual inspection in compliance with USP, Annex 1 and other cGMP regulations