GxP Lifeline

 

  • Mergers in Pharma Industry Diminish Productivity - Did You Know?

    MasterControl

    Recent studies indicate that mergers in the Pharmaceutical Industry significantly diminish productivity levels, especially in R&D. As with any merger, management and employees are plagued with personal uncertainty, but more importantly, with an inability to make swift decisions pertaining to joining pipelines, consolidating vendors and physical assets. During mergers, R&D talent also tends to slow down the combined entity, not to mention innovation as a whole.

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  • Medical Device Tax Means a 30% Spike

    MasterControl

    Did you know that if the 2.3% medical device excise tax fails repeal, the industry will need about $2.5 billion to comply with the next tax levy?

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  • Medical Device Companies Avoiding FDA Inspections? - Did You Know?

    MasterControl

    Sounds like a dream come true! Did you know that some medical device companies may be able to "avoid" FDA inspections?

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  • Medical Device Companies Required to Submit MDRs Electronically - Did You Know?

    MasterControl

    When the pending FDA rule is finalized it will require more than 56,000 medical device importers, manufacturers and other medical device facilities/professionals to submit medical device reports (MDRs) in an electronic format (otherwise known as electronic medical device reports (eMDRs)). eMDRs have been an option for medical device companies for a few years but this ruling—once finalized—will result in very significant changes that will be required by law for all medical device comp

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  • Life Science Manufacturers Analyzed in Aberdeen Report - Did You Know?

    the AberdeenGroup could not be categorized as Best-in-Class manufacturers?

    According to a recent AberdeenGroup report, life science companies face pressures that "typical" manufacturers do not. These pressures include "complying with government regulation and providing traceability in their operations." Because of these pressures, life science companies often stand at a mediocre level in terms of first pass yields, overall yields, and DPMOs (defects per million opportunities).

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  • More Than One Way to Kill CAPA - Did You Know?

    MasterControl

    A new approach to QMS and CAPA management isn't necessarily a revolutionized approach from the one your company already employs. Ken Peterson, CAPA expert and founder of Pathwise, Inc., states that "Making a few well-timed changes to build more intelligence into your process by having key questions prompt you from data point to data point can make it easier for those doing the work, as well as for those who need to see the logic."

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  • Adhering to ISO Standards - Did You Know?

    MasterControl

    It's no secret that adhering to ISO standards can help companies save money when economic times get tough but what is it about ISO standards that really makes the difference? Less waste? More consistent progress? Less time spent on quality administration? Or is it simply the confidence that ISO standards instill in employees by making processes and systems understandable at a deeper level?

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  • ISO Committees Are Available for Consultation - Did You Know?

    MasterControl

    An online article1 published on the ISO.org website makes it clear that companies that are seeking to become ISO certified can receive assistance regarding "horizontal" topics. This consultative assistance can be helpful for a wide range of companies participating in a variety of vertical markets.

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  • For Medical Device Companies - Did You Know?

    MasterControl

    Inspections of medical device facilities have already started to rise as funds set aside for the FDA have increased under the Obama administration. The need for these inspections, according to a recent article1 from FDANews, has led the agency to hire 450 inspectors to address device inspections as well as those inspections required within the drug and food industries. The article also refers to the new inspectors' large range of varied experience, touting them as "recent college graduates, indu

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  • eCTD Specification Document (Version 3.2) Provides Recommendations - Did You Know?

    14 April, 2017 MasterControl

    File names should only use lower case characters and hyphens and should have only one file extension that indicates the format of the file.  You should avoid using what are known as “special characters” in your file names such as punctuation, underscore, spaces, or other nonalphanumeric symbols.  The only exception to this is regarding SAS transport files to the FDA, in which they will allow underscores.  Internal corporate naming conventions that include date or

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  • Do you know how to navigate the FDA's website

    12 July, 2011 MasterControl

    by Carl Anderson, Regulatory Affairs and Quality Assurance Consultant

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  • History of Food, Drug, and Cosmetic Act - Did You Know?

    MasterControl

    by: Kevin Bogert, President of GxP Partners, LLC

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  • Health Canada and FDA Agree to Perform Joint Third-Party Inspections

    4 January, 2010 MasterControl

    Both the FDA and Health Canada (HC) found the proposal of joint third-party inspections to be beneficial. The decision was made after the pilot Multipurpose Audit Program was conducted by the agencies.

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  • GMP Training Exams - Did You Know?

    14 April, 2017 MasterControl

    In the FDA environment, adequate and continuous personnel training is essential in manufacturing safe, reliable, and high-quality products. Companies are required to implement and document GMP training to make sure that their personnel know how to perform their duties within company and industry guidelines. What better way to prove employee competency than through exams? When the FDA investigator comes, your employees should be able to demonstrate their skill level in their daily work, but exam

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  • A GHTF Proposed Guideline - Did You Know?

    MasterControl

    Supplier audits have long been of the utmost importance in the medical device environment and the inspection of products/services provided by suppliers is a practice well worth the time of conscientious manufacturers. However, for those manufacturers that disregard background checks on suppliers there may be a new "failure to comply" risk knocking at their door.

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  • Miconceptions Regarding Generic Drugs - Did You Know?

    MasterControl

    The FDA and the U.S Department of Health & Human Services recently updated and published a fact and myth sheet1 regarding generic drugs. The topic can certainly be a confusing one and this publication helps to "clear the air" when it comes to common misconceptions regarding generic (as opposed to brand name) drugs.

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  • FDA Draft Proposal Gets Strict With Clinical Investigators - Did You Know?

    MasterControl

    The proposal suggests a rule that would disqualify a life science clinical investigator (e.g, a clinical investigator working in the field of biologics) from working on clinical investigations associated with other life science fields such as pharmaceuticals or medical devices. The rule is designed to protect the subjects of clinical research across the various fields regulated by the FDA. The rule would also allow the FDA to harmonize investigator disqualification regulations across the board.

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  • FREE training from FDA CDRH Learn

    10 July, 2011 MasterControl

    For the medical device industry, it's not always easy to understand and correctly implement FDA regulations. CDRH (Center for Devices and Radiological Health) is providing a free online educational tool with training modules that describe "many aspects of medical device and radiological health regulation [that cover] both premarket and postmarket issues."1

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  • Increased Disclosure of Food, Drug and Med Device - Did You Know?

    14 April, 2017 MasterControl

    Did you know that democratic legislators are vying for the increased disclosure of food, drug and medical device information?

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  • Did you know that a newly issued final rule will affect Pharmaceutical and Biologics clinical trials?

    6 October, 2010 MasterControl

    For Pharmaceutical and Biologics companies that organize or participate in clinical trials, final rules issued by the FDA can have a significant impact on policies and procedures related to the implementation of a clinical trial. A recently issued final rule addresses how and when safety information must be reported.

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