European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift.

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Edge Biologicals Inc., Edge Biologicals Inc.,

FDA 83

FDA Food and Drug Administration Media Manufacturing 83

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Management 75

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 75

European Pharmaceutical Review

AUGUST 9, 2022

Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3 percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. Daddy Gaoh et al.

Food and Drug Administration 82

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 82

European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. In particular, purified water and WFI are critical when producing sterile pharmaceutical drug products. The research is focused on multiple processes, such as cleaning verification and formulation of drug products.

Food and Drug Administration 87

Food and Drug Administration Pharma Manufacturing Food 87