ISPE

MARCH 29, 2023

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. For purpose of illustration used throughout this article, labels have been assigned to each CQA.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. For purpose of illustration used throughout this article, labels have been assigned to each CQA.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. By employing an attribute-focused approach, an assessment of MW was performed based on a review of literature, process understanding, process performance, and historical PPG release testing data.

Documentation 52

Documentation FDA Packaging Communication 52