Current Good Laboratory Practices

The term current Good Laboratory Practices (cGLPs) was first introduced in the 1970’s in Denmark and New Zealand. Soon after that, it was used by the FDA and the Organization for Economic Co-operation and Development (OECD), referring to a quality system of regulation and management practices or requirements in research laboratories. Current good laboratory practices embodies different principles which are designed to ensure and promote consistency, quality, safety, reliability, and integrity of chemicals during non-clinical and laboratory testing.

The term cGLPs is most associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products. However, it applies to many other non-pharmaceutical agents such as color additives, food additives, food contamination limits, food packaging, and medical devices.

The actual regulations in the United States can be found in 21CFR58 and for the European Union on this link. Current good laboratory practices only applies to non-clinical studies and testing. It does not apply to clinical studies. This is extremely important because clinical studies are governed by Good Clinical Practices (GCP), the Declaration of Helsinki, and other regulations intended to protect human participant safety.

Current good laboratory practices are a quality management system, not a scientific management system and defines a set of quality standards for study conduct, data collection, and results reporting. Current good laboratory practices do not define scientific standards. If a study follows cGLPs, then you can be reasonably sure that the reported results were collected as outlined in the study protocol; however, you cannot be sure that the study actually addresses the scientific hypothesis. Current good laboratory practices would ensure that someone follows the recipe or guidelines of the experiment exactly as it is written down; however, it does not assure you that the steps was good or that the resulting item will be accurate or of high quality. And an accredited laboratory provides clarity around the responsibilities of key people involved in the study.

Whatever the industry targeted, cGLPs stresses the importance of the following points:

• Resources: Organization, personnel, facilities, and equipment.
• Characterization: Test items and test systems.
• Rules: Protocols, standard operating procedures.
• Results: Raw data, final report, and archives.
• Quality Assurance: Independent monitoring of research processes.

The implementation of cGLPs must be a collaborative effort, enthusiastically supported by top management and involving personnel. Implementation is best organized in the form of a project, with a team of persons deriving their authority directly from upper management. An accredited laboratory may also be considered since it helps giving a plus.

Gaining practical knowledge on cGLPs is critical, as it will guarantee efficacy of work and better productivity, as well as an accredited laboratory. Maintaining 100% safety and quality is priority number one to every clinical and research organization.