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). 3 (2020):e2970. 16 June 2020. 10 (2020):1861–75. 34 Maschan, M.,

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Journal of Pharmaceutical Sciences 109 (2020):1427–1438.

Documentation 52

Documentation FDA Communication Packaging 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. The purpose of the QTPP is to link the attributes of the DP back through the TPP to the needs of the intended patient population.

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. The purpose of the QTPP is to link the attributes of the DP back through the TPP to the needs of the intended patient population.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. October 2020. 16 October 2020. 6 US Food and Drug Administration. Burke, S.,

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 10, 2023

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. Scope The scope of the assessment was for country approvals received in the calendar years 2018–2020.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98