History, Duty & Importance of Good Laboratory Practice in pharmacology and toxicology
Good Laboratory Practices (GLP) are the norms and standards that govern drug safety investigations in nonclinical animal research. In response to a lack of quality and scientific uprightness in nonclinical toxicity studies in the mid-1970s, the FDA released the Guidance for Industry Good Laboratory Practices Regulations in 1978. Adherence to GLP rules provides solid proof of the uniformity, consistency, reliability, reproducibility, quality, and integrity of nonclinical safety data. Europe issued its own GLP regulations through the Organization for Economic Cooperation and Development (OECD) in 1981 to foster compliance on a broader scale. Both sets of regulations ensure the sturdiness of the non-clinical safety data submitted to the FDA for New Drug Applications (NDA) and assessed by regulatory bodies for use in human clinical research.
Most nonclinical investigations will generally come within the GLP regulatory standards under the operation of three leading figures, namely, Test Facility Management (TFM), Quality Assurance Unit (QAU) and Study Director (SD). These three parties are responsible for establishing GLP criteria to assure data quality and integrity that are directly connected to scientific issues and the application of its principles. Adhering to GLP enables Patrons to decide to perform this stage of research outside of GLP regulations if the purpose is only to examine preliminary drug safety by reviewing the drug’s absorption, distribution, metabolism, and elimination (ADME) qualities. GLP compliance is obligatory for investigations such as standard repeated dosage toxicity, genotoxicity, and safety pharmacology, allowing the FDA to decide not only to approve new pharmaceuticals or assess whether a drug should be removed from the market but also to ensure that all medications on the market are both practical and safe for human intake. Consequently, GLP criteria are essentially required, particularly for evaluating safety studies of clinical pharmacology and have become a decisive element in the acceptance of non-clinical research.
