Good laboratory practices (GLP) are a systematic approach following regulations and standards laid down by regulatory bodies. GLP regulations are primarily for drug development studies in animal models. It ensures the ethical treatment of animals and instills confidence in the validity, reliability, and integrity of nonclinical data. This non-clinical data is crucial for getting approval to test the drug in human studies. Therefore, GLP labs are critical for drug development studies. The current article explores the potential of GLP labs for better drug development outcomes.
GLP labs for better drug development outcomes
GLP regulations are an integral component of drug development studies. The US FDA issued the first guidance for GLP practices in 1978 due to a lack of quality observed in nonclinical toxicology studies. GLP regulations incorporate several sectors, including:
- General provisions
- Facilities and equipment
- Organization and staff
- Testing facility operation
- Experimental protocol
- Control and test animal models
- Reports and records
Usually, most preclinical studies require GLP compliance. However, in certain cases, GLP compliance may be optional. For example, exploratory genotoxicity, safety pharmacology, and general in vitro studies will not require GLP compliance. GLP labs may conduct these studies by analyzing the ADME properties of a drug product. The primary objective of these studies is to assess the primary tolerability of the drug and not come up with regulatory submission data. Such approaches ensure drug developers refrain from investing resources in GLP compliance for preliminary research. However, all data submitted with an IND application should comply with GLP compliance requirements.
A primary requirement of GLP compliance is an independent quality assurance unit. This unit must monitor individual studies to ensure all equipment, methods, records, controls, facilities, and personnel conform to regulatory requirements. Quality assurance units conduct regular audits to ensure and confirm that protocols and standard operating procedures have been followed while generating preclinical data. This audit can include confirming routine quality control steps, removing experimental data, and analyzing reports, protocols, and standard operating procedures.
Contract GLP labs can provide the necessary services while conducting preclinical research. Importantly, contract laboratories are independent of sponsor companies and have an unbiased approach toward experimental conditions. Additionally, contract laboratories stay up to date with current GLP regulations. The primary steps contract laboratories consider to maintain GLP compliance include tracking deviations, identifying these deviations, and assessing whether these deviations are planned or unplanned. This approach ensures that contract laboratories have all the matrix-associated deviations documented and can prevent them in the future.
GLP regulations ensure and protect the integrity and quality of nonclinical studies. Since its first inception in 1978 by the US FDA, good laboratory practices are now vital to nonclinical studies. Moreover, an independent unit assuring the quality of bioanalytical studies ensures that the conduct, analysis, and reporting of experimental data are reliable and reproducible. Besides, they are experts in assessing drug compounds administered through every route possible, accompanied by toxicity study and expertise in both GLP and non-GLP conditions. Therefore, unleashing the potential of GLP labs is critical for accelerating drug development outcomes.