2021-03-22
- HBEL PDE Cross contamination Cleaning validation
- Lille Grand Palais
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A3P Cleaning Validation Symposium
Next June 29th and 30th 2021, Socosur Tox will exhibit at the second edition of the A3P Cleaning Validation in Lille Grand Palais.
For this new edition, the A3P Cleaning Validation Comittee proposes a programme addressing the following themes:
- HBEL/PDE
- Manual cleaning
- Clean Hold Time /Dirty Hold Time
- Cross-contamination
- Cleaning Validation for Biotech companies
During this event, concrete and topical issues will be addressed throught experience sharing, conferences, an exhibition and interactive workshops.
Q&A “Questions and answers on implementation of risk-based prevention of cross-contamination in production" and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)” introduced Cross Contamination Control Strategy concept and linked it to cleaning validation process.
EMA clarify HBEL (Health-Based Exposure Limits) / PDE use in the calculation of validation requirements of cleaning validation, their use in risk management approach and cross contamination prevention.