European Pharmaceutical Review

AUGUST 3, 2023

The optimised framework aims to overall, drive higher product quality and improved patient safety. Summarising recommendations and best practices for CAPA process improvement, this whitepaper uses data collected from a pilot suggested in the MDIC’s initial whitepaper that proposed the framework.

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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. Common Technical Document [CTD] sections).

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Fuld

JANUARY 21, 2020

We often deploy our Intelligence Benchmarking Survey as a barometer for process improvement opportunities with many of our clients and over the years have found that nearly 60 percent of the organizations we’ve surveyed struggle with demonstrating and managing the perceived value of competitive and market intelligence initiatives.

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PQA

OCTOBER 22, 2024

The PQA Quality Essentials Webinar series provides education on the fundamentals of quality measurement, which is important for effective measure implementation and performance, and information about where and how PQA quality measures are used. Amplify the patient voice to improve the patient-centeredness of MTM programs.

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Impact Pharmaceutical Services

SEPTEMBER 15, 2023

Upstream processing advancements encompass fed-batch processes , improved cell culture media, advanced feeding strategies, and tailored bioreactor control. Downstream optimization targets increased throughput, reduced costs, and improved product quality maintenance.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 9 Among other things, the M4Q(R2) EWG is working toward “organizing product and manufacturing information in a suitable format for easy access, analysis, and knowledge management.” The authors propose using Module 2.3 Published 15 November 2021.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 9 Among other things, the M4Q(R2) EWG is working toward “organizing product and manufacturing information in a suitable format for easy access, analysis, and knowledge management.” The authors propose using Module 2.3 Published 15 November 2021.

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Documentation Dosage Packaging Communication 52