ISPE

MARCH 29, 2023

TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy. CPP 5 Test DS identity (S.4.1)

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy. CPP 5 Test DS identity (S.4.1)

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52