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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.
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
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.
Robert Schwarz studied biotechnology and quality management. After working in a medicinal lab as medical/technical analyst Robert Schwarz joined Shire (formerly Baxter), Vienna in 2001. Until 2005 he was coordinator of environmental monitoring. From 2005 until 2018 he was validation specialist responsible for equipment qualification, sterilisation validation and cleaning validation. Since 2010, he additionally is university lecturer in the field of biotech (core topics validation/qualification, aseptic processing, cleanroom technologies and QC).