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Pacific Rim Consulting, Inc. - NEWSLETTER

Volume 14 Issue 1 - Page 3 - Winter/Spring 2012

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OECD RECOGNITION PROGRAM

Although the “recognition program” utilized by many OECD member countries assures a facility meets a “pre-defined” set of standards prior to conducting studies, the programs are seriously flawed. Most of these “recognition programs” focus almost entirely on facility evaluations with minimal emphasis on studies and data quality. OECD GLPs are based on consensus of the member countries (e.g. what does everyone agree on) instead of the requirements of the most stringent members. Many countries new to OECD GLPS are running the GLP program utilizing the same procedures and personnel who implement all other accreditation programs. These “monitoring authorities” have no vested interest in the data from the facilities they are inspecting, and many have minimal experience with GLPs. GLPs were developed to assure the quality and integrity of data being submitted to FDA (and later EPA) in support of marketing permits. It is critical that the regulatory agencies conducting inspections of facilities have ample experience with GLPs and be able to assess the compliance of facilities as related to the quality and integrity of the data these facilities are producing. All of us that have been working under GLPs for a substantial amount of time have seen facilities that look great on the surface, but when evaluating the actual studies and associated data, the system falls apart. Without looking at the underlying data, studies and associated procedures and determining whether calibration/verification/validation procedures actually are suitable for the particular type studies, GLP “recognition” has no value. Most provisions of the GLPs require procedures and processes to be adequate. How can one determine whether procedures are adequate without a study to assess the procedures by? The focus of International GLPs has changed from data integrity and quality to an “ISO” type inspection system. Although the US system has its own issues, our regulatory inspections revolve around data quality and integrity. If the studies hold up to scrutiny and the facility systems are in place, the facility is deemed to be in compliance at the time the studies were conducted and the inspection is being performed. The following are only some issues I have with the various “recognition” programs:

  • All reagents and solutions in a “recognized” facility have a 10 year expiration date
  • SOPs at a “recognized” facility were 1-2 years past their scheduled review date at the time the recognition was granted
  • Monitoring authorities did not request any validation or ask about validation in an analytical laboratory
  • Four studies were selected for review with no findings at all on any of them
Although the US system of inspections has flaws, it is far superior to any type of “recognition” system, as Sponsors are held accountable (both in EPA and FDA) for assuring the compliance of studies and associated facilities. The regulatory agencies responsible for approving products establish inspection programs to assure the quality and integrity of the studies and data they are relying on to make such decisions. That is how GLPs were designed to work.

WCQTI provides a practical, scientific approach to Good Laboratory Practice Regulations, focusing on industry standards and common sense as well as the written code. Training materials are over 1400 pages (now on a handy CD!) and include numerous forms, SOPs, reference articles, and other material critical to interpreting the intent of the regulations. Courses are structured to be highly interactive, providing opportunities for workshops and discussions. Every effort is made to present subjects in an informative, energetic manner. Additional experts in their particular field are brought in periodically for certain courses.

ABOUT THE DIRECTOR

Ms. Deborah Eyer Garvin, MS RQAP_GLP, Director of the West Coast Quality Training Institute earned her MS in Agriculture from New Mexico State University. Ms. Garvin is also President of Pacific Rim Consulting, a Quality Assurance firm specializing in consulting and auditing for FDA, EPA and OECD GLPs as well as FDA GCPs for Target Animal studies. She provides contract QA services and training to Sponsor Companies, Project Management groups, Contract Laboratories, Universities, Teaching Hospitals, and individual test sites. Coming from a contract laboratory background, Ms. Garvin has implemented GLP compliance programs at several facilities, and understands the practical aspects of GLP compliance and adherence. Constant involvement in auditing and inspecting provides unique insights regarding current problems and issues, as well as cost-effective means of compliance. Numerous professional organizations have utilized her expertise as a consultant and invited speaker. Active in the Society of Quality Assurance, Debi is a Past President of the National organization, past chair of the SQA Registration Examination Committee, and was an original member of the Professional Certification Committee. She represented the Society of Quality Assurance at the OECD workshop held in the UK regarding multi-site studies, represented the FDA at the 2008 OECD GLP Harmonization workshop, and serves on the editorial board of the QA Journal. She is also a member of the SQA FDA Modernization of GLPs task force.

Seminars offered by WCQTI
not all seminars are offered every year, but all are offered for in-house training)

One Day Seminars

  • GLPs 101 (an Introduction)
  • GLP Essentials for Technical Staff
  • SOPs 101

Two Day Seminars 

  • QA Audits, Inspections and Responsibilities
  • GLPs - Black, White and Grey
  • GLPs for Scientists and Technical Staff
  • Application of GLPs to Field Studies
  • GCPs/GLPs in Target Animal Studies
  • GLPs in Medical Devices
  • • GLPs for Study Directors and Monitors

ON SITE TRAINING

Any seminar, combination of seminars, or individual topics can be customized to meet your company’s needs, and provided on site or at your choice of venues. Fees are invoiced at a flat rate with no “add-ons” or “per-person” charge. Call Debi at (541) 352-7120 for more information, email debi@pacrimqa.com or visit www.pacrimqa.com.