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 74

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 74

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.,

FDA 82

FDA Food and Drug Administration Media Manufacturing 82

PM360

OCTOBER 25, 2023

Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the pharmaceutical industry. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

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 86

Food and Drug Administration Pharma Manufacturing Food 86

Pharmaceutical Technology

JUNE 23, 2022

US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals. As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream. There are currently ten approved continuous manufacturing applications in the US.

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Government Manufacturing Food and Drug Administration FDA 64

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. Some countries have blocked parallel trade to prevent supplies from depleting.

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Pharmaceutical Food and Drug Administration Transportation Manufacturing 93

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

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FDA Food and Drug Administration Manufacturing Product sample 87