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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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Purdue to pay $8.3bn after admitting criminal charges in opioid case

pharmaphorum

billion in civil damages to states affected by the opioid crisis, which the Department of Justice said was the largest penalties ever levied against a pharmaceutical manufacturer. Purdue filed for bankruptcy last year, after it proposed a separate $10 to $12 billion settlement package to resolve those lawsuits.

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Tracking the Drug Trail

Pharmaceutical Technology

Data has long been incorporated into drug packaging to accomplish these goals, but only to a partial degree with embossed lot numbers, expiry dates and even Braille identification in addition to linear bar codes. For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011.