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The Importance (and Challenges) of Maintaining GLP

Posted by Derek Hayes on Aug 20, 2012 12:00:00 PM

GLP stands for Good Laboratory Practice, but what does this really mean?

Good Laboratory Practice is designed to promote the development of quality test data and provide tools and methodologies that ensure a sound approach to managing laboratory studies. This includes the execution of the study, as well as reporting and archiving of the study results. The ultimate goal is to be able to ensure that the results in one laboratory can be accurately compared to the results obtained in other laboratories.

OECD

The Organization of Economic Cooperation and Development (OECD), an organization consisting of 34 industrialized nations, has published a set of guidelines regarding GLP with the goal of ensuring a consistent approach to laboratory management. The OECD principles defines GLP as “...a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”

Who Enforces GLP?

In the United States, the FDA has rules for GLP in 21 CFR 58. Research not conducted according to this standard or under the OECD Guidelines may be inadmissible to the FDA. Around the world other governments, in conjunction with the FDA, are working together to promote consistency in scientific data. This is part of what drove the creation of the OECD guidelines.

With today’s global economy it is common for research to be done in multiple locations and labs. Outsourcing has contributed to this trend. So the establishment of GLP, and the ability to prove GLP to local regulatory bodies is paramount. You must be able to effectively show the reconstructability of the study, regardless of where the research was originally performed.

Ultimately GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. Yet one of the challenges is that national monitoring authorities can apply differing GLP interpretations.

 

What are the Challenges in Maintaining GLP?

With all the different areas addressed in the OECD guidelines and FDA standards, maintaining GLP can be a difficult challenge for any organization, large or small. The standard addresses topics such as:

  • Inspection
  • Quality assurance
  • Management
  • Animal facilities
  • Laboratory equipment areas
  • Equipment calibration and maintenance
  • Training
  • Standard Operating Procedures (SOPs)
  • Data management
  • A host of other areas

GLP means certain requirements must be completed so an audit can effectively obtain all the information related to a study performed under GLP guidelines.

 

How has GLP been done in the past?

GLP

Traditionally GLP records have been maintained in paper form.

Paper based systems are hard to manage, search and report against.

It’s difficult to pull together all the required information in response to an audit. When we look at the variety of information required to be tracked, along with the number of individuals involved, we can see the challenge this presents.

This ultimately leads to higher costs for maintaining GLP status.

8 Key items to address to achieve GLP:

  1. Laboratory Standard Operating Procedures (SOP)
  2. Materials documentation
  3. Materials quality - stock controls and expiry
  4. Equipment management
  5. Materials ordering documentation
  6. Quality processes
  7. Training records on documents
  8. Current versions of all training documents

Another challenge is there isn’t one individual who’s tasked with GLP compliance. It’s a responsibility shared by many in the organization.

Those Responsible for GLP Compliance can include:

  • Study Director – a Study Director should be assigned and has overall responsibility for the technical conduct of the study as well as for the interpretation , analysis, documentation and reporting of the results, and represents the single point of study control.
  • Quality Assurance Unit – maintains the documentation associated to the studies
  • Human Resources - Each testing facility shall maintain a current summary of training experience and job description for each individual engaged in or supervising the conduct of a non-clinical laboratory study.
  • Management – Designate and monitor the Study Director and Quality Assurance unit. Assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled. Assure that personnel clearly understand the functions they are to perform.  Make sure any deviations from these policies are reported on and acted upon, and documented.
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Topics: GLP, Good Laboratory Practices

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