ISPE

OCTOBER 1, 2022

Consistent Measurements from Lab-to-Process Improve Production. Consistent Measurements from Lab-to-Process Improve Production. Labs are then used to provide quality control monitoring as promising drugs move through process development on a pilot scale, followed by non-GMP and then GMP manufacturing. Company Name.

Process Improvement 52

Process Improvement Communication 52

ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Currently, it takes time and/or communications (e.g., July–August 2020).

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Currently, it takes time and/or communications (e.g., July–August 2020).

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. Accumulus Synergy White Paper. 2021.09.046.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. 65: Technology Transfer (revised 2022), aims to standardize the approach to technology transfers, which would include conducting risk assessments, process comparisons, and knowledge transfers. EFPIA White Paper on CMC Development, Manufacture and Supply of Pandemic COVID-19 Therapies and Vaccines.”

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

Pharmaceutical Technology

MAY 9, 2023

For Jamaels, whose track record in managing complex operations and delivering process improvements spans GSK Vaccines and one of the world’s largest companies, GE, the technological shift is an exciting development: “I’m passionate about the digital transformation that our industry is going through,” he says.

Vaccines 52

Vaccines Process Improvement Communication 52