Robert Schwarz, FH Campus, Vienna, Austria
Preventing cross contamination is an essential GMP-requirement and has already been mentioned in the EU GMP Guideline since its first publication in 1989. However, in the last years this requirement has become more and more relevant. There is a stronger focus on cross contamination since the EMA has published their „shared and dedicated facility guideline“ regarding the use of multi-purpose equipment. In this guideline, health-based exposure limits (HBEL) and permitted daily exposure-values (PDE) are implemented as state of the art values. Consequently, the chapter 5 of the EU GMP Guideline and the Annex 15 have been revised in the same direction. A Question and Answers (Q&A) draft document and now the final version should interpret EMA´s „shared and dedicated facility guideline“. De facto, these two Q&A´s have led to some confusion in the pharmaceutical industry.
We address staff from the pharmaceutical industry and API manufacturers who are interested in the topics cross contamination and cleaning validation, e.g. head of production, validation managers, QA-personnel etc.
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- What is a Q&A document?
- The PDE concept – how was it developed?
- Why the use of HBEL/PDE values?
- How to get HBEL/PDE values?
- EMA´s Q &A document for the interpretation of EMA´s
- “Shared and Dedicated Facilities” guideline
- Comparison of the Q &A draft (2016) and the final version (2018) – What changes?
- Influence of the Q & A document on cleaning validation
Recording from 19.10.2019
Duration of recording: 1,5 h.