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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It's not exciting, it's not cutting edge. It may be the last thing you think about when preparing for an FDA audit. You might scan the records and figure if all the lines are filled in, it must be okay. Or, the auditor might not look at it, so I will trust that the pharmacist did it correctly. After all, aren't pharmacists one of the most trusted professions? Consider this: if drug accountability is in question, then the whole study could be in jeopardy. Proving that the drug was administered to the patient that resulted in the effects seen from study drug is a key factor in determining the merit of a product candidate. The FDA has listed drug accountability as number three in a list of top five pitfalls.
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In August 2011 the Food and Drug Administration (FDA) released a guidance entitled "Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring," which highlights a new approach to clinical site monitoring different from that of years ago. In this most recent guidance, the FDA openly states that "Many sponsors have understood that FDA expects sponsors to conduct frequent on-site monitoring and 100% data verification for all trials," clarifying that this is not always the best approach or the most productive use of time.
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In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn't changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations.
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A year has passed since the Food Safety Modernization Act (FSMA) was signed into law. Some of the changes envisioned under the FSMA are already in place, such as the FDA's new mandatory food-recall authority and the authority to detain food products that the agency has reason to believe are adulterated or misbranded.
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Note: The views expressed in this article are those of the author and do not necessarily represent those of the employer, GxP Lifeline, its editor or MasterControl Inc.
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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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Mobile technology has come a long way. Smartphones and tablets are getting better, smaller, and less expensive. It is no wonder that almost everyone has one.
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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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Note: The views expressed in this article are those of the author and do not necessarily represent those of his employer, GxP Lifeline, its editor or MasterControl Inc.
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Compliance audits present their own orientation to an organization that wants to present the perfect front while being asked to air their dirty laundry. Is this inspection about smoke and mirrors or does the audited facility present a "zipped-tight" posture toward the investigator?
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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 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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Note: The views expressed in this article are those of the author and do not necessarily represent those of her employer, GxP Lifeline, its editor or MasterControl, Inc.
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With the goal of optimizing collaborations in the drug development industry, Nice Insight (http://niceinsight.com/) developed a quarterly survey to measure customer awareness and customer perception across 300+ contract research and manufacturers. Nice Insight's Q4 Pharmaceutical and Biotechnology Outsourcing Survey generated responses from 2,619 outsourcing-facing executives from big pharma (29%), specialty pharma (17%), emerging/niche/start-up pharma (22%), biotechnology (25%), and emerging biotechnology (7%). In addition to creating a research tool that aids sponsors in the outsourcing partner selection process and enabling CROs and CMOs to understand their position within the industry, Nice Insight also garners broad industry trends from its survey data.
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Compliance is often seen as a subjective word, and at best can mean something very different from one functional area to another within the same organization. The compliance requirements for a quality group are very different from those in R&D groups such as Clinical and Regulatory Affairs. Technology and processes can play a significant role in defining and meeting compliance requirements, however if the technology is not flexible and configurable it can become difficult to implement one solu
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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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Hedley Rees looks at the problems with the pharmaceutical supply chain and questions whether they can be resolved.
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One of the most costly areas of business for any Pharmaceutical or Biotechnology Company has always been clinical research. Now more than ever the cost of bringing a product to market is staggering and as patents on trademark products expire the hope for recovering costs of research get smaller and smaller.
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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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