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.

Documentation 52

Documentation Process Improvement FDA 52

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.

Documentation 59

Documentation Process Improvement Compounding 59

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.

Process Improvement 78

Process Improvement Documentation 78

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.

Documentation 52

Documentation Dosage Packaging Communication 52

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.

Documentation 52

Documentation Dosage Packaging Communication 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. Common Technical Document [CTD] sections).

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 11, 2023

Then substantial time and resources are needed to run the same manufacturing process at the receiving site and test the resulting product in quality control (QC) laboratories or use emerging technologies, such as PAT or RTRT, to generate release and characterization data demonstrating analytical comparability. EMA/CHMP/BWP/187162/2018.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52