GxP Lifeline - Blood and Biologics

The GxP Lifeline Blood and Biologics newsletter consists of general feature stories, articles for specific sectors, a list of conferences, trade shows, and other events for life science professionals as well as a monthly Did You Know piece. For each article, we also include links to related articles and websites.

Blood and biologics regulations are also summarized, discussed or analyzed in many of the Lifeline articles. Regulations discussed may include 21 CFR Parts 1270 and 1271, 21 CFR Part 11, additional FDA regulations and/or international regulations. Standards that apply to the Blood and Biologics industry may also be discussed. These standards include ISO 9000, ISO 9001, ISO 14000, ISO 15189 and ISO 17025.

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

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Newsletter Editions

• GxP Lifeline January - March 2012 Issue
  
  

  Is FDA to Blame for Biomedical Industry's Slow Growth?
  Is Your Executive Management Team as Involved with the Quality System as They Should Be?
  Annex 11 and 21 CFR Part 11: Comparisons for International Compliance
  End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals
  
  Full Issue



• GxP Lifeline October - December 2011 Issue
  
  

  Reading the FDA Tea Leaves
  What to Expect When They're Inspecting - Part I
  Is There a Legal Requirement to Have SOPs for GCP in Europe?
  
  Full Issue



• GxP Lifeline July - September 2011 Issue
  
  

  Writing and Enforcing Your SOPs for GxP Compliance Success
  How to Build a Business Case for a Quality Management System
  
  Full Issue



• GxP Lifeline May 2011 Issue
  
  

  Certification and Advanced Degrees: Are They Worth It?
  
  Full Issue



• GxP Lifeline April 2011 Issue
  
  

  Quality Inspiration: Six Quality Quotes for You to Consider
  
  Full Issue



• GxP Lifeline March 2011 Issue
  
  

  Developing a Supplier Scorecard: Devising Aspects of Supplier Performance
  
  Full Issue



• GxP Lifeline February 2011 Issue
  
  

  Why Baldrige Works
  
  Full Issue



• GxP Lifeline January 2011 Issue
  
  

  Minimizing the Risk of Donor Disease Transmission
  
  Full Issue



• GxP Lifeline December 2010 Issue
  
  

  Seven Signs that Your Quality Program is in Trouble
  
  Full Issue



• GxP Lifeline November 2010 Issue
  
  

  Four Common Quality Misconceptions
  

  19 Key Elements to Review for Effective Audits
  
  Full Issue



• GxP Lifeline October 2010 Issue
  
  

  Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program: Part 2
  
  Full Issue



• GxP Lifeline September 2010 Issue
  
  

  Defining GxP Training/Learning: Part 1
  
  Full Issue



• GxP Lifeline August 2010 Issue
  
  

  Tissue Tracking Failures and Lessons Learned - Hope for the Future
  
  Full Issue



• GxP Lifeline July 2010 Issue
  
  

  Stop the Madness! Process Control for Continual Improvement
  Nonconformance Management: Key to FDA and ISO Compliance
  Quality Basics Simplify Complex Engineering Document Management Challenge
  
  Full Issue



• GxP Lifeline June 2010 Issue
  
  

  Quality Risk Management Approach to ISBT Validation
  Six New FDA Enforcement Policies: How They Impact You
  Computer System Validation: FDA Inspections
  
  Full Issue



• GxP Lifeline May 2010 Issue
  
  

  Validation of Off-the-Shelf Software
  How Auditing Supports Supply Chain Management
  Quality Audit - A Tool for Continuous Improvement and Compliance
  
  Full Issue



• GxP Lifeline April 2010 Issue
  
  

  Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review
  Improving Data and Content Migration Testing: A Top Ten
  Change Control: Continuous Quality Improvement in FDA and ISO Environments
  
  Full Issue



• GxP Lifeline March 2010 Issue
  
  

  Designing a Learning and Performance Program in Tissue and Organ Banking
  Ten Signs Your CEO Still Has No Idea About ISO 9011 and Lean
  Automating Training Control Processes to Comply with FDA and ISO Requirements
  
  Full Issue



• GxP Lifeline February 2010 Issue
  
  

  Better Innovation for Product Development and Process Improvement
  The Challenges of Change Control
  
  Full Issue



• GxP Lifeline January 2010 Issue
  
  

  Automating Document Control Processes to Comply with FDA and ISO Requirements
  Data and Content Migrations: Minimizing the Risk
  
  Full Issue



• GxP Lifeline December 2009 Issue
  
  

  The Changing Face of Biobanks
  The 5 "W"s of Quality Agreements
  
  Full Issue



• GxP Lifeline November 2009 Issue
  
  

  FDA Chooses MasterControl's QMS
  Biologic-Device Combination Products: Jurisdiction
  
  Full Issue



• GxP Lifeline October 2009 Issue
  
  

  Please Don't Call Them CAPAs
  Avoiding the CAPA Calamity
  
  Full Issue



• GxP Lifeline September 2009 Issue
  
  

  Increasing Efficiency Through Lean Principles
  Writing and Maintaining SOPs: Drudgery or Delight?
  
  Full Issue



• GxP Lifeline August 2009 Issue
  
  

  Cells and Tissue Traceability and ISBT 128
  
  Full Issue



• GxP Lifeline July 2009 Issue
  
  

  Legal Risks Affecting Blood Banks
  Designing a Winning CAPA System
  
  Full Issue



• GxP Lifeline June 2009 Issue
  
  

  QMS Pains in the Blood and Biologics World
  
  Full Issue



• GxP Lifeline May 2009 Issue
  
  

  Good and Bad Responses to 483s
  
  Full Issue



• GxP Lifeline April 2009 Issue
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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.
  
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• GxP Lifeline July 2008 Issue
  
  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
  
  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
  
  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
  
  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 March 2008 Issue
  
  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
  
  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?
  
  Full Issue



• GxP Lifeline January 2008 Issue
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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
  
  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.
  
  Full Issue