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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.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

Warning letters issued by FDA can be an important source of data to study and analyse violations that occur in pharmaceutical manufacturing. Such studies can also help companies prepare for their upcoming inspections by enabling them to identify and rectify any issues.

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Tackling fake pharmaceuticals: an industry united against counterfeit products

European Pharmaceutical Review

Consequently, pharmaceutical manufacturers risk their reputation if impersonating products fail to deliver the expected quality or health impact. These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture. But what exactly does this look like? .

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. In 2015 he joined the Process Chemistry & Catalysis group at F.

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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. An FDA warning letter delivered to Edge Biologicals Inc.

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Is J&J nearing the end of its opioid liability hangover?

pharmaphorum

The settlement relates to Duragesic (fentanyl), Nucynta (tapentadol) and Nucynta ER products, which have not been on sale in the US since 2015. According to the AP, around 40 states have now signed up to the national settlement package, which could be announced later today.