Contenuti:
Nel corso della giornata sono stati trattati i seguenti argomenti:
· Quality standards and guidances: overview related to the main Regulatory Authorities
· Starting material and API starting material: justification for the positioning in a multi-step process
· Compliance to D.Lgs219/2006: use and import of API starting material
· Traceability, supply chain and QP declaration: which impact for the drug product
· Impurity profile and carryover of related impurities: recent approaches for identified and unidentified impurities
· Solid state: why the increasing interest for the solid state of APIs?
· Modern trends in quality and regulatory aspects of herbal Extracts
· Analytical procedures and validation: how to guarantee the robustness of data and compliance with regulations
· Stability data and attribution of retest/shelflife
· Submission of data: ASMF or CEP?
· Electronic submission: use of e-CTD
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