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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. Q8(R2) Pharmaceutical Development. Boca Raton, FL: CRC Press.

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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 3

Express Pharma

The company had falsified sterility test results and manufactured under unqualified cleanroom conditions. This event led to criminal convictions and highlighted the deadly consequences of GMP fraud in sterile manufacturing. FDA found critical cleaning validation failures and poor process controls at the Teva facility in California.

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Popping the Gross-to-Net Bubble, Part IV: Extreme Examples of Who Grew the Bubble

Pharmaceutical Commerce

It is fair to say that the pharmacy benefit managers (PBMs) enabled it, but pharmaceutical manufacturers took advantage of it. PBMs contractually allowed pharmaceutical manufacturers to raise list prices within their annual contracts to a negotiated ceiling. It does indeed take two to tango.

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World Standards Day: Recognizing How Standards Enable a Strong Medicines Supply Chain

Quality Matters

In a 2019 report on drug shortages, the FDA found that 62% of drug shortages occur because of quality issues in manufacturing. Quality issues in pharmaceutical manufacturing can arise in many ways. USP is applying its knowledge in medicine standards to new solutions to make the supply chain more resilient.