FDA Guidance for Industry:Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline
Title:
FDA Guidance for Industry:Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Core Guideline
Origin/Publisher:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609205.pdf
Content:
This guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products.