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  • Compliance

    • cGMPs

    Current Good Manufacturing Practice regulations (cGMPs) provide for systems that ensure proper design, monitoring, and control of manufacturing processes/facilities. Because deviations from cGMPs often result in 483s and warning letters from the FDA, it’s vital that pharma companies stay up to date on the latest changes in this area of their business.

    Articles

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    Key considerations for CGMP raw materials compliance

    It is never too early to consider CGMP requirements in pharma

    Intas hit with FDA warning letter

    The letter revealed that an analyst used acetic acid to destroy CGMP records
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    Beyond ‘good’ practices

    Pharma quality regulation has evolved beyond routine CGMP compliance toward a more holistic, proactive approach

    Biocon hit with multiple 483s

    Biocon, India's biggest biopharma, has revealed that the U.S. FDA has issued three Form 483s following inspections of the manufacturing facilities of its Biocon Biologics arm....
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    Developing a cell and gene therapy packaging strategy

    Optimal packaging and labeling solutions help ensure the delivery of safe, effective viral vector products
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    Toward a collaborative pharma ecosystem

    A new biomanufacturing era demands that suppliers and manufacturers partner to efficiently bring new therapies to market
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    Getting drug quality right the first time

    CAPA remains an integral element of cost-effective quality management in pharma
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    Pharma’s hybrid inspection model

    Four strategic steps to creating and executing a hybrid audit protocol
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    Emergent BioSolutions: The path to re-emergence

    How the Bayview plant put itself — and pandemic preparedness — on a better course
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    Engineering Angles: Is your cold storage energy use through the roof?

    How a commonly overlooked component of pharma facilities is impacting your bottom line

    Quality woes thrust Emergent back in the spotlight

    Earlier this week, new reports revealed that a production mistake at an Emergent BioSolutions facility contracted by Johnson & Johnson to make its COVID-19 vaccines lead to the...

    Fresenius Kabi pleads guilty to destroying records before FDA visit

    Fresenius Kabi Oncology pleaded guilty to concealing and destroying records before a 2013 FDA inspection of its API manufacturing site in Kalyani, India

    FDA issues countrywide import alert on Mexican hand sanitizers

    Warning that hand sanitizer imported from Mexico could be tainted with dangerous chemicals, the U.S. FDA has issued its first-ever countrywide import alert for any category of...

    Fresenius Kabi recalls sedative, again

    Fresenius Kabi announced another voluntary recall of a single lot of injectable dexmedetomidine hydrochloride, due to cross-contamination with lidocaine.
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    Stealing pharma's sunshine

    How sunscreen is driving a resource and capacity shortage