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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

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.

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Understanding endotoxin cartridge testing: frequently asked questions

European Pharmaceutical Review

A : FDA-licensed cartridges utilise the kinetic chromogenic method and are fit to test any type of endotoxin sample including, but not limited to, waters, raw materials, in-process samples, final products, medical devices and radiopharmaceuticals. Are LAL and rCR cartridges licensed by the FDA? rather than the 0.98

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Cleanroom microbiology: single-temperature incubation for EM

European Pharmaceutical Review

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

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. Eight FDA warning letters were handed to European companies in 2018.

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How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?

pharmaphorum

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. Until the company is found to be in compliance, there will not be a normal distribution of drug products. About the Author.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Implementing PAT in (bio)pharmaceutical manufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility. Q13 Continuous Manufacturing of Drug Substances and Drug Products.