FDA Guidance for Industry:Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline

Titel:
FDA Guidance for Industry:Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline
Herkunft/Verlag:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609205.pdf

Inhalt:
This guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products.

Zurück

GMP Seminare nach Thema