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Qdossier Qsauri
"P"

post-approval change management protocol
Guideline or reference source
ICHQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Definition
A regulatory tool that provides predictability and transparency in terms of the requirements and studies needed to implement a change as the approved protocol provides an agreement between the MAH and the regulatory authority.
Abbreviation for
PACMP
Used For
comparability protocol
 

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