PMA Approval Checklist

PMA Information

Verification Item	Status	Comments
GMP responsibilities of each party are clearly defined	Acceptable Not Acceptable
Quality unit roles, authority, and independence are defined	Acceptable Not Acceptable
Regulatory ownership and notification responsibilities are defined	Acceptable Not Acceptable
Change control, deviation, and CAPA responsibilities are defined	Acceptable Not Acceptable
Audit rights, record access, and retention requirements are defined	Acceptable Not Acceptable
PMA aligns with approved specifications, SOW, and internal SOPs	Acceptable Not Acceptable

Approval Decision	Approved Approved with Revisions Rejected
Required Revisions / Notes

QA Reviewer Name		Signature
Date