2010, Food and Drug Administration and Pharmaceutical manufacturing

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2010

Food and Drug Administration

Pharmaceutical manufacturing

Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA

FDA Food and Drug Administration Pharma Pharmaceutical manufacturing

An Annex 1 and Pharma 4.0 perspective on water quality

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

Food and Drug Administration Pharma Manufacturing Pharmaceutical

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Common pharma compliance concerns cited by FDA warning letters

An Annex 1 and Pharma 4.0 perspective on water quality

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