European Pharmaceutical Review

JANUARY 27, 2025

The inevitable shift to external manufacturing sites necessitates a seamless technology transfer process, and should incorporate unique perspectives on local approaches to knowledge transfer, quality, regulatory and all other operational requirements pertaining to the sites locality.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

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 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

SEPTEMBER 11, 2023

Although the novelty of these modes of manufacturing has led to some definitional ambiguities, initial working definitions and terminology have been drafted by several regulators, trade organizations, and subject matter experts. Nature Communications 12, no. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M.,

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. IDMP Definition of Identification of Medicinal Products.”

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 21 , 22 In this context, the term recycle has a few definitions. You may unsubscribe from these ISPE communications at any time. 7 An integrative (vs. incineration with profitable heat use).

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52