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GxP Lifeline

Showing items tagged as SOP

  • 2021-bl-sop-review_132x132

    FDA Inspection Preparation: SOPs, Process Maps, and Gap Analysis

    With proper preparation and the right tools, a manufacturing organization can always be ready to pass a U.S. Food and Drug Administration (FDA) inspection relatively stress-free. Process mapping and gap analysis can help manufacturers not only show the FDA that a company is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.

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  • 2021-bl-writing-enforcing-sop_132x132

    Writing and Enforcing GxP SOPs for Compliance

    A look at the data collected by the U.S. Food and Drug Administration (FDA) makes it clear that in life sciences, standard operating procedures (SOPs) tend to be a compliance problem. Digital tools and good practices for writing and enforcing SOPs are key to making them effective and compliant.

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  • 2021-bl-fda-eu-inspections_132x132

    FDA vs. EU Inspections: Similarities and Differences

    In 2009, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched an initiative to harmonize regulatory supervision of clinical trials. It streamlines collaboration and information sharing between the two regulatory bodies on good clinical practice (GCP) inspections. Quality and compliance expert Maria Dorat gives an update on the initiative and explains how harmonization is working during COVID-19.

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  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.

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  • mc-logo-220x25

    Writing and Enforcing Your SOPs for GxP Compliance Success

    Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.

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