Showing items tagged as deviation

  • 2020-bl-change-pharma-mfg_thumb

    Deviation and Change Control in Pharmaceutical Manufacturing

    In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.

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  • 2019-nl-bl-thumb-change-control-continuous-improvement

    4 Change Control Pain Points in High-Stakes Manufacturing (and How to Overcome Them)

    Documenting change control is a crucial part of the manufacturing process. Without it, operations can become error-ridden, ineffective and at worst – they can result in costly product recalls that are damaging to consumers and companies. Learn how a digital quality management system can ensure product quality, safety and prevent delays and recalls.

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  • 2019-bl-thumb-fda-warning-letters

    Prelude to an FDA Warning Letter

    Receiving an FDA warning letter usually sets off a chain reaction of required responses, follow-up tasks and additional correspondence that effectively keeps a regulated company from getting product out the door. This article discusses some of the common reasons life sciences companies receive warning letters and provides tips on how to avoid receiving one.

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