Reflection Paper: Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed
Title:
Reflection Paper: Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed
Origin/Publisher:
EMEA
Document Type:
EMEA Reflection Paper under development
Content:
This reflection paper has been published by the EMEA PAT team to provide preliminary recommendations on how PAT related information should be presented in applications or variations to Marketing Authorisations.