Change control in Excel files by TEAMS
The presentation deals with the tracking of changes in Excel files possible in MS Office 365. The conditions for this are: - The file must be saved in Teams or in a SharePoint. - Version control must be switched on and correctly configured in SharePoint In the "Review" menu you will find the options "Show changes" and "Version history". With [...]
Typical errors / misunderstandings during US FDA inspections
The presentation deals with investigative inspections as they are typically conducted by the FDA or other international regulatory authorities. It addresses typical mistakes that are often made in inspections, as well as misunderstandings that may even stem from one's own lack of knowledge about the products that are registered on the US market. The presentation is based on [...]
Categorization for device qualification - The limits
Anyone who deals with the topic of GMP today must inevitably also deal with the topic of "qualification". In doing so, one quickly realizes that the subject is a time-consuming, costly and personnel-intensive matter. The person is also confronted with all the difficulties of a precise definition and interpretation and with the question: "How do [...]?
Annex 1 and ISO 14644 - The same path to a clean room?
Annex 1 as a legal requirement for the design of processes and production environments is supported and supplemented by DIN EN ISO 14644 with regard to the design and qualification of cleanrooms. This standard is explicitly referenced in some cases and is therefore legally binding for certain content. Other content has established itself independently as "best practice" [...]
Real-time airborne germ measurement: pharmaceutical process environments
The updated version of EU GMP Annex 1 mentions the possibility of introducing alternative methods for microbiological contamination control, which can provide results as real-time methods directly during the measurement. This is intended to detect possible contamination in critical process environments more quickly and thus reduce the risk to product quality. Microbiological real-time methods in air are based on the excitation [...]
World first: 3D printed GMP single-use bioreactors
The AppliFlex ST GMP is a customizable single-use bioreactor that meets all cGMP requirements for clinical applications. It enables a seamless process transition from R&D to clinical production. Single-use bioreactor for cell and gene therapy and mRNA applications - Seamless process transition from research to clinical production (both scale-up and scale-out) - Designed to meet the requirements of [...]
Practical tips for setting up a personnel airlock
Personnel airlocks serve as access to pharmaceutical production and cleanrooms or as a transition between two cleanroom classes and play a decisive role in ensuring production safety. What needs to be considered when choosing materials, equipment and processes and what options are available? We provide answers to these questions using practical examples.
Standard-compliant and effective test equipment management
Standard-compliant and effective test equipment management and calibration - Evidence for continuous process verification in accordance with Annex 15 What does test equipment management involve? Difference between factory and accredited calibrations What needs to be calibrated and how? Determining the points and references to be calibrated - based on what? How do I integrate this into the continuous process verification required by Annex 15 [...]?
Support for the CCS (Contamination Control Strategy)
Supporting the CCS (Contamination Control Strategy) through metrological testing and verification What does a CCS involve - how can it be supported/implemented metrologically? How does cyclical cleanroom qualification fit into the concept and what are the findings? What can flow visualization contribute and what needs to be considered? What needs to be considered for calibration & mapping [...]?
Filtration technology for production processes in cleanrooms
This presentation will discuss contamination control in cleanrooms, highlighting the challenges in the various process steps in relation to HEPA and AMC filtration. Process safety and risk management are the key success factors for efficient processes and product reliability. Product contamination is not only problematic and costly - it also damages reputation and image and delays [...]