European Pharmaceutical Review

DECEMBER 1, 2023

There is definitely an interest in advanced therapies, such as cell and gene therapy, plasmids, mRNA, and viral vectors. or 2x, that is definitely seen as a success and [worth] being explored through an oral route. We are certainly seeing requests or demands for large molecules to be explored for oral delivery.

Dosage 98

Dosage Process Improvement FDA 98

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

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. These new operating models can help enable and accelerate the efforts of Pharma 4.0™

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy.

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. 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. 7 An integrative (vs. Recycling programs for spent single-use consumables include partnerships such as MilliporeSigma/Triumvirate.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52