The Society for Quality Assurance (SQA), a professional membership organization dedicated to promoting and advancing the principles and knowledge of quality assurance, recently held its 24th annual meeting in Memphis. SQA Director Catherine Bens provides this overview of the meeting for GxP Lifeline readers.
HHS Secretary Mike Leavitt recently announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. The Sentinel Initiative will strengthen FDA's ability to track the performance of drugs and other medical products once they enter the marketplace and improve the agency's ability report safety information to the public.
Is the Common Technical Document new to your company and authors? Are you unsure about what eCTD "granularity" means? Templates optimized for eCTD granularity and for Adobe Acrobat Portable Document Format (PDF) requirements may help you comply with international regulatory guidelines for PDF requirements for eCTD submissions.
In a very real sense combination product manufacturers are changing the face of life science research and manufacturing. In fact, the near future may paint the combination products sector as the leading life science industry sector, while products like transdermal patches for depression, dental bone grafting material with a growth factor, absorbable collagen sponges with genetically engineered human protein, or a surgical mesh with antibiotic coating may become more common than their "less complete" components.
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.
Like sunscreen, you don't want to be outside without the mosquito repellent. Those annoying insects carry more than just a nasty bite---these days, they may carry West Nile virus, too.
At a corporate level, quality and compliance management in heavily regulated pharmaceutical environments is a tricky endeavor. After all, success in the areas of quality and compliance can only be achieved when a multitude of variables are controlled and continually maintained. From document control to CAPA control, and from audit to CRO management, quality and compliance—to avoid oversights—requires full attention and/or automation over all pertinent details.
This article presents six significant quality and compliance oversights that pharmaceutical companies may unknowingly propagate or encourage over time.
Did you know that democratic legislators are vying for the increased disclosure of food, drug and medical device information?
Did you know that the pharmaceutical industry is undergoing a technology shift? eCTDs for example are subject to change, and their continuous evolutions are promoting discussion in areas and initiatives such as RPS (Regulatory Product Submission).