ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Titel:
ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Internet:
Herkunft/Verlag:
ICH
Inhalt:
This new guideline is proposed to provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle.