Impact Pharmaceutical Services

SEPTEMBER 15, 2023

Both processes are evolving to enhance product development and output. Upstream processing advancements encompass fed-batch processes , improved cell culture media, advanced feeding strategies, and tailored bioreactor control.

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. . <Read

Process Improvement 78

Process Improvement Documentation 78

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” [link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” [link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. EMA/CHMP/BWP/187162/2018. 22 March 2018. www.ema.europa.eu/en/documents/report/meeting-report-joint-biologics-working-party/quality-working-party-workshop-stakeholders-relation-prior-knowledge-its-use-regulatory-applic

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 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

AUGUST 30, 2022

Case studies are presented that demonstrate the importance of defining the raw material attributes that are critical to product quality and how this could support increased postapproval flexibility (including the use of ICH Q12 principles). and the impact on supply resiliency. Additional requirements are described in ICH Q7.

Documentation 52

Documentation FDA Packaging Communication 52