ISPE

SEPTEMBER 10, 2023

Connor Dennis, PhD Roger Nosal 1 September 2023 As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. WHO Expert Committee on Specifications for Pharmaceutical Preparations.” Watson, PhD Melinda Imperati S.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Depending on the nature of the change, manufacturers may be required to maintain both the pre-and post-change equipment, processes, or methods until all approvals are received. 1 September 2022.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines contain information regarding regulatory requirements for raw materials.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

Herein, DM refers to a manufacturing model in which many units or facilities are disseminated across different geographical areas 6 , 7 DM facilities may produce similar or identical products under a unified pharmaceutical quality system (PQS) or operate as independent units with different outputs. Journal of Pharmaceutical Sciences 111, no.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements. This, in turn, can lead to drug stock outs and shortages.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52