GxP Lifeline

 

  • 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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  • New FDA Guidelines for Informal Medical Device Application Review - Did You Know?

    14 April, 2017 MasterControl

    Since more resolute performance goals have been set forth by the agency after the 2007 FDA Amendment Act, increased interaction during the review process between the FDA and life science industries has become an issue of note. According to the guidance, interactive reviews will facilitate increased informal interaction between the FDA and applicants and enable the exchange of vital scientific and regulatory information. To view the guidance, follow the link below.

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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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  • 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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  • Whats in Your Toolbox? Choosing the Right Tool for Quality Improvement

    14 April, 2017 Bonnie Messinger

    Quality improvement tools are like any other tool set. Each basic tool has a brood of new and improved versions intended for increasingly specialized applications. A seasoned facilitator may have literally hundreds of tools at her disposal. However, finding a few basic favorites and learning them well is sufficient for most applications.

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  • Electronic Submissions Must Be in eCTD Format - Did You Know?

    14 April, 2017 MasterControl

    The eCTD delivery mechanism streamlines the submission process by insuring that only the most up-to-date documentation is submitted. FDA will still allow hard-copy paper submissions but after December 31, 2007 other electronic formats (such as eIND, eNDA or hybrid eCTD/eNDAs) will no longer be accepted. All regulated organizations intending to send submissions electronically are urged to contact the FDA prior to preparing submissions using the eCTD specifications. Start a dialogue with the FDA a

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  • FDA's Sentinel System - Did You Know?

    14 April, 2017 MasterControl

    The Food and Drug Administration's (FDA) Sentinel Initiative was launched May 2008 in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA).1 The FDAAA provisions mandated that the FDA take the lead in developing an electronic surveillance system to increase the agency's capacity to monitor regulated medical products on the market. Although the FDA has a number of systems already in place to track adverse events and product problems, these monitoring tools all represent a p

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  • Document Review Process Can Reduce Document Review Cycles

    13 April, 2017 MasterControl

    Studies undertaken by PleaseTech's PleaseReview™ customers show that using collaborative document review can reduce document review cycles by as much as 65 percent. Take for example a 45-page document that has a document review cycle of 14 days. This 14-day period is made up of two seven-day periods. The first seven-day period consists of a five-day initial review followed by a two-day author consolidation. This period is followed by a second seven-day period (post comment consolidation) t

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  • Eliminating 'Rogue' Document Issues - Did You Know?

    13 April, 2017 MasterControl

    Although, certainly, the prospect of securely managing a corporation's "controlled content" is a challenging proposition, especially in today's fast-paced, Internet environment, where electronic documents can be readily copied, distributed, and shared with virtually anyone, there is a solution, one that effectively defies even the most challenging of loopholes.

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  • Pharmaceutical Companies Identify Ways to Improve - Did You Know?

    13 April, 2017 MasterControl

    Single sourcing is a "write once, use many" approach to support the implementation of standard operating procedures (SOPs) and approved work instructions by allowing companies to enter their operating instructions into a single repository in order to automatically generate and update critical training and performance support materials.

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  • Phamaceutical Companies Have to Increase Reliance on Technology - Did You Know?

    13 April, 2017 MasterControl

    Compliance with FDA’s eCTD requirements need not be a burden for any size company when “renting” a solution is just as effective as making the investment to buy a solution.

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  • Did You Know?

    13 April, 2017 MasterControl

    St. Louis, Mo., as the number of organ transplants continues to increase throughout the world, so too are the number of organ transplant recipients developing skin cancer.

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  • Did You Know...

    13 April, 2017 MasterControl

    That you can bring your team together in a virtual workspace for collaborative projects?

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  • Dietary Supplements Testing

    13 April, 2017 Sharon Phillips

    As noted in previous articles (see May 2008 issue of GXP LifeLine for example), the primary purpose of the final FDA Rule on Dietary Supplements (21 CFR Part 111) is to assure that current good manufacturing practices (cGMP) are followed and documented. The final FDA Rule on Dietary Supplements does not require manufacturers of dietary supplements to test their products before they are marketed.

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  • Effective Nonconformance Management Key to FDA and ISO Compliance

    13 April, 2017 Jason Clegg, Marketing Director, MasterControl, Inc.

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • The Buzz on West Nile Virus

    13 April, 2017 Robyn Barnes

    Summer's onset brings that familiar buzz of the bug we all love to hate: the mosquito. The itch, the swelling, the unsightly bumps on the skin---not to mention the scratching---are the annoying price we pay for outdoor fun.

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  • Tissue Banking - Good Tissue Practices GTP - Regulations, Operations and Medical Oversight

    13 April, 2017 MasterControl

    An Interview with Ted Eastlund, M.D., by Robyn Barnes

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  • Blood Community Meets to Discuss Priorities

    13 April, 2017 MasterControl

    Clearly, there is no substitute for blood. There is no substitute for safety in handling blood, either. From donations at blood and tissue centers to transfusions in hospitals, the primary concern is for the purity of this life-giving fluid. The Food and Drug Administration (FDA) requires that blood establishments face some of the toughest regulations and standards today to ensure the safety of the blood supply.

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  • HCT/P Inspections: Most Common Deviations

    13 April, 2017 MasterControl

    Total of 36 Product Recalls Last Year for HCT/P Sector

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  • QMS Pains in the Blood and Biologics World

    13 April, 2017 Rob Carpenter, Product Manager, Customer Relationship Manager and Blood and Biologics Expert, MasterControl

    Maintaining a quality system within a blood and biologics organization is a very resource-intensive endeavor. Changes resulting from new regulations, new and updated procedures, new techniques, changes in suppliers and supplies, new and enhanced safety practices, and the like, all result in a massive amount of change that must occur across the organization. Managing these changes in turn requires the assignment of multiple resources across multiple areas of an organization. These are just the qu

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