ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. In an attempt to address these challenges, in 2019 the ICH endorsed ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (and Annexes).

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

JULY 5, 2023

This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization. Generally, CM is fit for processes with high repeatability requirements, as is the case for pharmaceuticals.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

The Thyroid Pharmacist

JULY 20, 2023

Not only is iron deficiency often missed because one of the most important tests for iron deficiency isn’t a routine test, but it can be more challenging to correct than simply taking a supplement. The body needs red blood cells in order to get oxygen from the lungs, to the rest of the body.

Health and Personal Care Stores 59

Health and Personal Care Stores HIV Treatment and Prevention Agents Insurance Immunization 59