The importance of GLP compliance for CROs

Good Laboratory Practice (GLP) refers to a quality system of extensive research related controls or principles that govern the manner in which scientific research should be conducted to ensure integrity, quality and reproducibility. In the U.S., the principles of GLP are described in the Food and Drug Administration’s (FDA) Code of Federal Regulations, Title 21, Part 58 (21CFR58).1

The principles of GLP were first introduced in Denmark and New Zealand in 1972. In 1976, these principles were introduced in the U.S. following a Senate subcommittee hearing on gross scientific misconduct at Industrial BioTest (IBT) Laboratories, one of the largest and oldest product testing laboratories in the U.S. Investigators had discovered that IBT had either falsified or was unable to reproduce thousands of safety and toxicology test data performed for chemical manufacturers of pesticides and household products. These hearings led the FDA to enact statutory authority for GLP in 1979 by way of the Code of Federal Regulations, 21CFR58.2

The guidelines for GLP are laid out in several subparts of 21CFR58 to ensure the quality, integrity and safety of non-clinical laboratory data. The subparts discuss: personnel, facility, equipment, standard operating procedures, test reference articles, protocols, reporting of results and archiving the data. Laboratory work must be performed by appropriately trained and qualified personnel in a secure and suitable facility with testing equipment that is calibrated and well maintained. Management approved standard operating procedures and study protocols must clearly define the housekeeping and technical operations of the testing facility and the nature of the tests performed. Proper documentation of study data and related material including testing material, reagents, reference standards and test systems is critical to ensuring that the study data can be evaluated, repeated and, if need be, reconstructed at a later date. Moreover, all study data and associated documentation must be stored and archived for two to five years, depending on the intended purpose of the data, should reevaluation of quality, integrity and safety need to be performed at a later date.

GLP does not guarantee that a scientific study will generate novel, innovative data. GLP guarantees that the study is performed with integrity and that the data can be reproduced. Work done according to GLP recognizes that the data generated may ultimately be used to influence decisions affecting public health and safety.

Since our inception, Custom Biologics™ has combined GLP with innovative science. Maintaining a GLP compliant environment can be expensive and time consuming. It requires attention to equipment maintenance and calibration and to extensive documentation and reporting. Although these procedures may extend the time required completing a study, in our experience the overall benefits of adhering to GLP far outweigh the drawbacks. Compliance with the principles and practice of GLP has brought great rewards to both our employees and clients. We have been able to attract the best and brightest scientists. The Quality Control System in place at Custom Biologics™ constantly monitors all projects and conducts all test procedures in compliance with 21CFR58. Our work meets the highest globally recognized standards and has repeatedly been used to support submissions for New Drug Applications.

Custom Biologics™ continues to advance into new areas of regulated bioanalytical testing of both small and large molecules.

Great science is at the heart of everything we do.

References

1. http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ ucm135220.htm 2. Baldeshwiler, A.M. History of FDA Good

Laboratory Practices. Quality Assurance

Journal (7) 3 2003.

Dan Mamelak is Founder and President at Custom Biologics.

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