ISPE

MARCH 29, 2023

Published June 2008. 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. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published June 2008. 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. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.”

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. Published 2008. This is followed by DP manufacturing, where the DS is formulated with excipients.

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. Bolivia, Hong Kong, Malaysia, Philippines, and Vietnam). Commission Regulation (EC) No.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98