GxP Lifeline Publications

Welcome to GxP Lifeline Publications! Every month, we publish feature articles and other information for life science companies, especially those in the areas of pharmaceutical, medical device, CRO, blood/biologics, clinical/medical laboratory, and biotechnology.

The publications consists of general feature stories; articles for specific sectors; a list of conferences, trade shows, and other events for life science professionals. For each article, we also include links to related articles and websites.

We hope that you'll find this complimentary newsletter informative and interesting — a virtual space that you and your colleagues can always return to.

View the Lifeline Publications

• GxP Lifeline Pharmaceutical
• GxP Lifeline Medical Device
• GxP Lifeline Blood & Biolgics
• ISO Lifeline (Coming Soon!)

Before Industry Specific Editions

• GxP Lifeline April 2009 Issue - FEATURE -

  Once an electronic system has gone through the validation process and is in production, users can access it to initiate, review, and approve documents in accord with the SOPs against which they have undergone training. The validation process will have set specifications for the system based on user requirements, so the system will be able to accommodate all the documents the system has been built to hold, and to identify users by passwords linked to the users' names.
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• GxP Lifeline March 2009 Issue - FEATURE -

  Electronic systems require four essentials: validation, security, audit trails, and accountability. None of these are clear cut, and companies still struggle to make sense of the very vague Part 11 regulation - which itself was slated for revision by 2006 to focus on risk, but industry has yet to see it. The current, original final rule provides little help in the actual "how to" for bringing a system on board, and more than one company has found itself mired in the transition process after having selected a suitable vendor, agreed to contractual terms, and purchased a configurable off-the-shelf (COTS) software program.
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• GxP Lifeline February 2009 Issue - FEATURE -

  FDA holds corporate management, not the quality assurance department, responsible when outsourcing decisions go bad. Whether you're outsourcing manufacturing, clinical trials, IT services, pharmaceutical ingredients, circuit boards, or anything else, the ultimate responsibility for your product is yours and yours alone. Management can't pass responsibility down the supply chain like a hot potato.
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• GxP Lifeline January 2009 Issue - FEATURE -

  As corporate corruption, with or without executive intent, increasingly comes to light within the life science sector the FDA is reciprocally given additional power to administrate punitive measures. Take for example the punitive measures doled out to the Purdue Frederick Company: $634.5 million after the defendants pleaded guilty to the intentional misbranding and the illegal promotion of the company's OxyContin drug."
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• GxP Lifeline December 2008 Issue - FEATURE -

  In today's fast-paced business environment, collaborating is the name of the game. To complete a task, working with other employees or suppliers is often required---and challenging. Kate Merlino of nSight shares her experience in working successfully with collaborative environments."
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• GxP Lifeline November 2008 Issue - FEATURE -

  Former FDA Associate Commissioner Peter Pitts recently chaired the Risk Management and Drug Safety Summit in Washington, D.C. He describes it succinctly as "A content-rich experience."
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• GxP Lifeline October 2008 Issue - FEATURE -

  Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments of the medical device and pharmaceutical industries. From simple record control through electronic signature approval routing and automated records processing, the validation of these functions can offer a substantial challenge to the average IT or QA personnel not familiar with computer systems validation activities. Specific to these challenges are the validation of electronic spreadsheets or forms.
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• GxP Lifeline September 2008 Issue - FEATURE -

  Whether we are assessing vendors like software developers whose products are used in the automated processes for manufacturing of pharmaceuticals or medical devices, or the less technologically driven processes like pharmaceutical distribution channels for supply chain integrity, the process of inspection can help create useful data to support development of technology for specific uses.
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• GxP Lifeline August 2008 Issue - FEATURE -

  The recently published report, The Cost of Quality: a Study on Life Sciences, is a benchmark study by the AberdeenGroup. The report compares the quality standards and tactics of life science companies from the pharmaceutical, biotechnology, blood/biologics and medical device industries with those of Best-in-Class manufacturers. According to the report, "Aberdeen surveyed 169 […] companies identifying themselves as life
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• GxP Lifeline July 2008 Issue - FEATURE -

  Poor records – and poor management of good records – can trigger needless costs, penalties, and public embarrassment for FDA-regulated companies. And if managing your own records isn’t challenging enough, FDA holds you equally responsible for ensuring the quality of records generated by your suppliers, contractors, and vendors. To protect the integrity of your regulated products and your company’s reputation, you must be proactive and continuously monitor the activities and records of each link along your supply chain, including suppliers and vendors whose activities may affect the safety and efficacy of your final product. Even if FDA does not directly regulate all of your suppliers, it’s ultimately your responsibility to ensure their records accurately reflect what’s happening at their sites.
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• GxP Lifeline June 2008 Issue - FEATURE -

  For those that have never attended an SQA annual meeting, this year's meeting, like those of the past, offered professionals working in the pharmaceutical, agricultural, and chemical industries a unique opportunity to network with sponsors, peers, regulators, consultants and vendors and to attend a wide array of educational presentations, posters, and special events all carefully designed to highlight current issues critical to the conduct of regulated research in a fast-paced, fun atmosphere.
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• GxP Lifeline May 2008 Issue - FEATURE -

  In June 2007, the U.S. Federal Drug Administration issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule (21 CFR Part 111) for companies involved in any phase of the manufacturing, packaging, labeling or holding of dietary supplements. The deadlines for meeting the requirements of 21 CFR Part 111 are June 2008 for companies having over 500 employees, June 2009 for companies having between 21 and 499 employees, and June 2010 for companies having fewer than 20 employees.
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• GxP Lifeline April 2008 Issue - FEATURE -

  How crucial is Europe to the global pharmaceutical market? First consider that Europe, North America, and Japan comprise 80 percent of the world pharmaceutical market. Take that statistic in conjunction with the estimation from Report Buyer, a renowned market research firm, that the Western European market alone is expected to grow to $245.3 billion by 2012.
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• GxP Lifeline March2008 Issue - FEATURE -

  For companies doing business in regulated environments, the benefits of implementing software systems are abundant. Improved product safety, higher quality, enhanced efficiency, and increased probability of maintaining regulatory compliance are just a sample of the numerous benefits computerized systems can provide. Why, then, do so many companies resist implementing software systems?
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• GxP Lifeline February 2008 Issue - FEATURE -

  There’s an old joke that goes, “You know it’s going to be a bad day when you get to the office and find Mike Wallace of 60 Minutes waiting for you.” If you feel this way about auditors, maybe you’ve got the wrong impression. Who are auditors and what do they really do?
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• GxP Lifeline January 2008 Issue - FEATURE -

  QA and IT departments are by nature two very distinct animals. Who would have thought however that disconnects between the two departments currently cost pharmaceutical companies millions of dollars?
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• GxP Lifeline December 2007 Issue - FEATURE -

  An optimal quality management system is the foundation for long-term
  regulatory compliance and enduring market success. Without a solid
  quality infrastructure, your organization is not prepared to face the
  challenges of ensuring continuous regulatory compliance.
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• GxP Lifeline November 2007 Issue - FEATURE -

  At a recent workshop, Barbara Cassens, Director of the FDA's San Francisco District Office, identified ten specific FDA regulations for which medical device companies (as of July 30, 2007) most commonly receive FDA 483 Observations and Warning Letter citations.
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• GxP Lifeline October 2007 Issue - FEATURE -

  It’s a well-known fact that pharmaceutical and medical device companies are slow in adopting some of the most basic technologies. Does this hurt their productivity, quality, and time to market? Find the answer.
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• GxP Lifeline September 2007 Issue - FEATURE -

  Of the 242 medical devices recalled by the U.S. Food and Drug Administration (FDA) between 1992 and 1998 for reasons related to software failures, “192 (79 percent) were attributable to changes made to the software after its initial implementation.”
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• GxP Lifeline August 2007 Issue - FEATURE -

  Of the 242 medical devices recalled by the U.S. Food and Drug Administration (FDA) between 1992 and 1998 for reasons related to software failures, “192 (79 percent) were attributable to changes made to the software after its initial implementation.”
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• GxP Lifeline July 2007 Issue - FEATURE -

  A recent survey of 176 manufacturers throughout the world shows that more than half of best-in-class companies enforce enterprise-wide quality procedures as a top business strategy.
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• GxP Lifeline June 2007 Issue - FEATURE -

  How does process mapping help medical device and pharmaceutical companies turn inputs into predictable outputs that would help them comply with regulations, as well as realize commercial success? There is not a magical formula for successful process mapping, but here are some “do's and “don'ts.”
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• GxP Lifeline May 2007 Issue - FEATURE -
  Consumer complaints are at the heart of every product recall. Whether it’s Merck’s voluntary recall of the pain medication, Vioxx, or the Class I recall of counterfeit LifeScan blood glucose test strips, chances are both actions stemmed from complaints. The following are some of the most common complaint-handling issues faced by FDA-regulated companies and practical tips on solving them.
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• GxP Lifeline April 2007 Issue - FEATURE -
  Why is training important to life science companies? The FDA states it clearly: “Quality is the responsibility of every employee — any employee can generate a quality problem through ignorance of their job requirements or negligence.”
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• GxP Lifeline March 2007 Issue - FEATURE -

  Under GxP principles, quality audit should be conducted periodically as a tool for evaluating the effectiveness of the total quality system. But for most life science organizations, quality audits can be daunting. Here are some of the most common challenges pertaining to quality audit and tips on solving them.
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• GxP Lifeline February 2007 Issue - FEATURE - For life science companies, change must be managed not only because it’s inevitable but also because uncontrolled change could affect product safety and quality.
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• GxP Lifeline January 2007 Issue - FEATURE - Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.
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