ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). You may unsubscribe from these ISPE communications at any time. 7 An integrative (vs. For more information or to unsubscribe, review our Privacy Policy or contact us at ask@ispe.org.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 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. You may unsubscribe from these ISPE communications at any time.

Documentation 52

Documentation FDA Communication Packaging 52

The Nontraditional Pharmacist

APRIL 10, 2025

Retail pharmacy provided experience working with patients and staff from varied perspectives, and insight into process improvement. My traditional roles refined these people and process improvement skills, enabling me to build field hospitals in challenging environments with limited resources.

Detail Orientation 52

Detail Orientation Process Improvement Hospitals Vaccines 52

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

Documentation 52

Documentation FDA Packaging Communication 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. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M., 1 (2021):7200. 35 Anguille, S., 36 Sterling, J.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

SEPTEMBER 10, 2023

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. You may unsubscribe from these ISPE communications at any time. Leave this field blank Regulatory Adv Manuf QA

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

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