Managing GLP Studies in Non-GLP Facilities

Instructor: Anne E Maczulak
Product ID: 702342
  • Duration: 90 Min

recorded version

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This 90-minute webinar will help you understand when a new product being developed begins to fall under the umbrella of a regulated study, teach you the basic principles of GLP study to better separate regulated activities from basic research, provide practical tips on how to keep GLP-related materials separate from non-GLP materials, and manage equipment designated for GLP use.

Course "Managing GLP Studies in Non-GLP Facilities" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

An increasing number of companies and universities are running GLP studies or study phases in facilities that have never before been part of a regulated environment. Performing a GLP study in a non-GLP facility presents special challenges. If these challenges are not addressed properly, parts of a study might be non-compliant, increasing the risk of study rejection. This presentation describes the obvious challenges in running GLP studies in labs where non-GLP and other unrelated experimentation occurs. It offers tips on how to manage and separate GLP activities from non-GLP activities.

This webinar begins by clarifying what constitutes a GLP study. It explains where development work ends and GLP regulations begin. It describes the important transition between new drug development, which is not governed by regulations, and safety testing, which is in the scope of GLP. The presenter gives tips on good recordkeeping for the synthesis methods used in new drug development. The discussion also describes the risks of not understanding the GLP/non-GLP distinction. It describes the challenges of running regulated studies in the same lab as basic research. Special examples in equipment use, reagents, reference standards, and storage units are discussed.

The discussion provides details on the highest risk areas in studies conducted inside non-GLP facilities. By highlighting these areas, course attendees understand the main processes on which to focus in their own laboratories. Tips are given on how to avoid the biggest errors in these areas, errors that can lead to 483s, warning letters, and other regulatory actions against a laboratory. In serious cases of GLP and non-GLP crossover, studies have been rejected by regulatory agencies.

In addition, tips are given on how to label reagents and equipment for GLP use only. As part of this discussion, the webinar stresses the importance of detailed and continuous training of all laboratory personnel who might enter the facility. Attendees will learn how to keep their GLP activities secure from scientists with no knowledge of GLP requirements. Special attention is given to the role of testing facility management in helping this all work. The webinar concludes with a discussion how laboratories manage the occasional crossover of non-GLP activities into a GLP study. The risks of this occurrence are covered. The webinar also describes how any instances of non-GLP activity should be addressed in the final report compliance statement.

Areas Covered in the Seminar:

  • What constitutes a GLP study?
  • What are the biggest risks in mixing GLP and non-GLP work in the same facility?
  • How to separate GLP from non-GLP reagents
  • How to keep test articles and reference standards away from non-GLP
  • How to divide labs into GLP and non-GLP zones
  • How to identify testing facility management
  • How to train graduate students, interns, etc., in GLP
  • What goes into the compliance statement when non-GLP activities are part of a GLP study?

Who Will Benefit:

This webinar is for all facilities or laboratories that perform both GLP and non-GLP work using shared space, equipment, reagents, and/or scientists.

  • University laboratories
  • Startup companies in drugs, biotech, devices
  • Established companies with new programs in GLP
  • Sponsors, test facility or test site managers, study directors
  • University test site management, study directors, and QA officer

Regulatory Affairs, Scientists and QA professionals from the above will benefit.

Instructor Profile:

Anne Maczulak, PhD, RQAP-GLP, is an independent consultant at Acorn GLP Consulting. She has more than 20 years experience as sponsor, study director, or participating scientist in preclinical studies. Anne works with established companies, startups, and universities in need of guidance in GLP regulations. She has presented webinars for FDA and training courses for the Society of Quality Assurance. She audits laboratories that conduct nonclinical studies and/or bioanalysis and provides on-site as well as remote training in GLP.

Topic Background:

Many facilities employ a mix of basic research, method development, and nonclinical studies in the same building or in a common laboratory. Universities often house GLP and non-GLP work under the same roof. Some facility managers believe that such dual-purpose facilities are an invitation to regulatory non-compliance. On the contrary, in difficult economic times, companies and universities have learned to wear many hats. As part of this multitasked approach to research and development, laboratories often perform regulated studies (GLP) on the same day and at the same lab bench as non-regulated (non-GLP) studies.

There are several risks in conducting GLP studies in non-GLP facilities. Examples of high-risk areas are: test article contamination; reference standard contamination; reagent mix-ups; calibration errors in validated equipment; and chain-of-custody gaps in sample handling.

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