European Pharmaceutical Review

DECEMBER 1, 2023

Dr Kane leads a team of subject matter experts at Thermo Fisher, covering drug products in both sterile injectable dosage and oral solid dosage forms. Small molecules continue to be of interest going into oral solid dosage forms” AK: That’s a very interesting question that can be addressed in a few different ways.

Dosage 85

Dosage Process Improvement FDA 85

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. CPP 5 Test DS identity (S.4.1)

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. CPP 5 Test DS identity (S.4.1)

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. POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52