GxP Lifeline

Showing items tagged as FDA

  • 2020-bl-501k-guidance_132x132

    FDA Details Post-COVID Transition Guidelines for EUA Devices

    In February 2020, the FDA granted emergency use authorization (EUA) to certain medical devices needed to address the challenges imposed by the COVID-19 virus. The agency recently drafted two new guidances to make preparations for med device companies to return to normal regulatory operations.

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  • The History of the FD&C Act and Consumer Protection

    Life Before Consumer Protection and the Food, Drug, and Cosmetic Act

    Starting as a small Bureau of Chemistry taking an interest in chemical preservatives, the FDA has grown into one of the largest agencies in the world and accounts for 20 cents of every consumer dollar spent. Although no one is keen on rules, as we look back on history it is clear why FDA regulations are crucial when it comes to consumer protection. Being able to keep up with their extensive list of standards is now only possible through digitization. Lucky for us, we are in an era of rapidly developing technology that will make it possible for manufacturers in all industries to gain quick FDA approval and be on market in record time.

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  • 7 21 CFR Part 11 Med Device Manufacturers Compliance Requirements

    21 CFR Part 11 Compliance: 7 Must-Have System Features for Medical Device Manufacturers

    21 CFR Part 11, the regulation that defines the requirements for electronic records and signatures, can so overwhelm medical device manufacturers that many persist with their inefficient paper-based processes. But device firms that hesitate to digitize are falling behind. Learn seven core requirements electronic systems must address to remain compliant.

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  • 7 key concepts to understand the FDA’s Quality System Approach for the Pharma Industry.

    7 Key Concepts in the FDA’s Quality System Guidance for Pharma

    These seven concepts are critical to understanding the U.S. Food and Drug Administration’s guidance “Quality Systems Approach to the Pharmaceutical Current Good Manufacturing Practice Regulations.”

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  • MasterControl’s Quality Management System: a solution for pharma’s data integrity issues

    Data Integrity in Pharma is Key to Compliance

    The FDA has signaled that data integrity is increasingly central to the drug approval process. Pharma organizations need to take the cue and adopt a quality management system that improves their ability to record and manage data, which will streamline their compliance efforts.

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  • GxP Lifeline, a blog by MasterControl: image of hands scrolling on a tablet with a city background

    Not-To-Be Missed Blog Posts From 2021

    Before 2021 is gone, catch up on our most informative blogs that will help you conquer the challenges you’ll face next year.

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  • 2021-bl-personalized-medicine-trends-2_132x132

    3 Ways to Rethink Regulatory Change in Personalized Medicine

    As the field of personalized medicine grows and evolves, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) take steps to address regulatory oversight in the field, affected organizations should brace themselves for change and use it to their advantage. Here are three ways that companies in personalized medicine can approach regulatory obstacles as opportunities instead.

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  • 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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  • scientists-working-on-a-digital-touch-screen-in-lab-132

    Regulatory Records Primer: Decoding the Requirements for Medical Device Manufacturers

    The U.S. Food and Drug Administration (FDA) set up the Quality System Regulation (QSR) to give medical device companies guidelines for ensuring quality, safety, and efficacy of their devices. There are many components to the QSR, but this post focuses on the requirements that apply to records.

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  • 483s

    How to Avoid Pharma’s Top 5 FDA Form 483 Triggers

    Form 483 inspectional observation reports from the FDA result in painful and costly nightmares for pharmaceutical companies. Learn the top five reasons the agency issues Form 483s and find out best practices for steering clear of them.

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  • 2021-bl-automating-document-control2_132x132

    Why Automation Is Essential for Document Control Compliance

    Global regulatory agencies continue to evolve their processes and technologies to help companies achieve compliance with this critical aspect of quality management. This post explores document control automation practices as well as the efforts of global regulatory agencies to encourage modernization among life sciences companies.

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  • 2021-bl-drug-accountability-clinical-trials_132x132

    Ensuring Drug Accountability in Clinical Trials

    Drug accountability in clinical trials holds the organizations and people involved accountable for how they handle the drug being used. Accurate records are essential for compliant and reliable results.

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  • 2021-bl-cfr-part-11_132x132

    20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.

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  • 2021-bl-matt-lowe_132x132

    How to Not Fail an Inspection

    When I worked for medical device manufacturers, I experienced more than my fair share of audits and inspections. Even though we had good systems in place and strived for compliance, we still frequently weren’t prepared. If we had used connected digital systems, we could’ve saved ourselves a lot of worry and problems.

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  • 2020-bl-manufacturing-excellence-02_132x132

    Test Method Validation, Measurement Systems, and Gauge R&R

    To compensate for the lack of agency guidance and still meet regulatory requirements, the medical device industry turned to Gauge Repeatability & Reproducibility (Gauge R&R) studies, but the FDA is making it clear these studies are not a suitable tool for validation.

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  • 2021-bl-fda-483-observation_132x132

    Top Reasons for Med Device Form 483s and Warnings

    Maintaining compliance in medical device manufacturing is colossal and complex. Any number of things can slip through the cracks and fall into the lap of a regulatory inspector. MasterControl’s industry brief “Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments” helps companies identify and mitigate issues before they lead to extra work and costly delays.

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  • 2020-bl-quality-excellence-03_132x132

    Solving Quality Problems: Go Beyond Root Cause to ‘Real’ Cause

    Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.

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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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  • 2020-bl-asca-final-guidance_132x132

    The FDA Publishes Three-Part Final Guidance on ASCA Pilot Program

    In Sept. 2019, the U.S. Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH) introduced the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. The program was set up to foster an accredited conformity assessment arrangement between medical device manufacturers, accreditation bodies and testing laboratories. The FDA released its final guidance in Sept. 2020. This article highlights key aspects of the updated guidance.

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  • 2021-bl-fda-called_132x132

    The FDA Just Called! Are You Ready for an Inspection?

    If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you panic or would you go on about your day, business as usual? FDA audits can be stressful, and failing one can have significant consequences. With proper preparation, however, the call to schedule an FDA inspection doesn’t have to be so unnerving.

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