Cross-contamination Risk Assessment in Pharmaceutical Manufacturing - EU edition MasterClass

It is common practice in the Pharmaceutical Industry to manufacture multiple drug products in shared facilities with shared equipment. To avoid cross-contamination, all surfaces with product contact are cleaned prior to manufacturing of the subsequent product. According to current EU GMP requirements, the cleaning process has to be validated taking into account the API specific PDE (“Permitted Daily Exposure”) values. The EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” finalised 2014 and a Q&A paper published by the EMA in 2018 deal with the topic of cross-contamination and going far beyond cleaning validation.