ISPE

MARCH 29, 2023

Published June 2008. [link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published June 2008. [link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

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. Concerning the Examination of Variations to the Terms of Marketing Authorisations for Medicinal Products for Human Use and Veterinary Medicinal Products.”

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98