Good laboratory practices (GLP) are basic principles defining the requirements for planning, performing, monitoring, recording, and archiving safety studies. The safety studies maintain the integrity and quality of experimental data supported by regulated workflows. GLP labs conduct studies that are submitted to regulatory bodies for demonstrating and assessing the safety and efficacy of drug products. Hence, whether it’s a pharmacokinetic CRO or an HPLC lab, good practices laboratories are critical for unlocking reliable data during drug discovery and development studies.
Organizations, such as OECD, set the framework and scientific principles for testing standards and protocols in GLP studies. Besides, drug development should adhere to country and region-specific data and safety requirements to gain product authorization in that specific region. The current article explores the importance of GLP labs in achieving reliable drug development data.
GLP labs for efficient drug development analysis
The primary goal of GLP regulations is to ensure transparency, comprehensibility, and quality of drug development studies. The study director, personnel, and test facility management are responsible for structuring and completing studies within regulated GLP conditions. All associated study personnel must be adequately qualified with appropriate training, education, and experience.
GLP labs plan, perform, monitor, and report all bioanalytical studies with efficient quality assurance and reviews. Besides, each test facility should be inspected by appropriate authorities. Additionally, study protocols and results must be thoroughly documented to ensure that all assay steps are transparent, reliable, and easily retraceable. Besides, records and protocols must be properly archived after completing a study for the lifespan of that drug product.
Different steps of good laboratory practices
Each GLP study comprises three critical steps: study plan, execution, and final reporting. Each study plan defines the aim of a particular experimental study. It mentions the primary reason, the study personnel involved, and the time and place of the study. Moreover, GLP labs review all study protocols before initiating the study to ensure completeness, compliance, and quality with applicable regulatory guidelines.
GLP labs ensure study integrity by conducting experiments according to the planned standard operating procedures. The primary goal of standard operating procedures is to achieve consistent, efficient, and quality research. Besides, each study includes an inspection step to verify that study parameters conform with quality assurance.
In the final reporting stage, all findings and study details are incorporated into the final report, which is then reviewed by quality assurance personnel. This review process ensures all methods, results, and standard operating procedures are accurately reflected in the final report. This report is then sent to related regulatory authorities as the final dossier.
Often, GLP studies have checks and reviews, including regulatory assessments and third-party personnel, to confirm that the results apply to the market. GLP labs often perform internal and external inspections to ensure data accuracy and reliability. Additionally, each study and data undergo individual quality control by personnel not directly involved with the experiment. All these requirements are integral GLP study components to ensure its rigorous safety and planning for reliable and reproducible data.
In Conclusion
GLP-compliant studies ensure the reliability and reproducibility of experimental data during drug discovery and development studies.
