Regulatory compliance is crucial in toxicology studies. Non-compliance with GLP requirements may result in regulatory rejections, delayed approvals, and substantial financial losses. Good laboratory practices (GLP) are regulatory frameworks governing nonclinical studies, including toxicological assessments necessary for drug development and chemical safety evaluations. The primary role of the GLP Lab environment is to ensure reliability, data integrity, and regulatory acceptance. A robust GLP implementation directly translates into accurate safety and testing data submission to regulatory bodies.
Regulatory framework and GLP requirements for toxicology studies
Before experimenting with drug compounds in human trials, drug developers evaluate compounds in nonclinical testing and toxicity studies to demonstrate the safety and efficacy of the compound and its readiness for human testing. These nonclinical studies come under GLP regulations. GLP regulations were first enacted in the 1970s to ensure researchers do not submit falsified or fraudulent data to the FDA.
The goal of GLP regulations is to ensure researchers conduct nonclinical studies in a documented, traceable, and controlled manner. These rules maintain the integrity and quality of safety testing data that are critical for supporting IND and IDE applications and market approval of drug products.
According to the federal rules governing the testing of FDA-regulated products, nonclinical studies are in vivo or in vitro studies that assess the test article or compound under predetermined conditions to determine its efficacy and safety. These rules govern a broad range of testing, including acute, sub-chronic, and long-term toxicology testing, in vivo mutagenicity testing, and carcinogenicity testing. Animal and human clinical testing are excluded from GLP studies. Moreover, exploratory evaluations determining the chemical or physical properties of a drug candidate are exempted.
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Additionally, the manufacturing of a drug product in a lab is also exempted from GLP regulations. Instead, manufacturing comes under GMP regulations. GLP regulations include a wide range of specifications.
Specifications Under GLP Regulations
Let us explore the specifications in detail.
Personnel
Before beginning a study, the testing facility should appoint a study director to oversee the conduct and its GLP compliance. The facility should have a separate quality assurance unit independent from management or facility organization.
Facility and equipment
The testing facility should have separate areas to prevent disturbances or interference during activities. The facility should have separate areas for handling test and control compounds, storage of test articles, housing test systems, etc. Besides, all equipment should be routinely calibrated and maintained.
Characterization
Study personnel should know each control and test article. They should know the identity, composition, stability, purity, expiry dates, quantities, and storage instructions.
Study protocol
The study plan is a master document that outlines the study criteria and protocol. Besides, it includes the material and methods used in the study. The study director should approve, review, and discuss this protocol with study personnel and other staff members. After approval, the quality assurance unit should assess the protocol for GLP compliance.
Standard operating procedure
Each specific area of a testing facility should have a standard operating procedure, particularly for routine procedures. The testing facility manager should approve and review all standard operating procedures. Importantly, the study director should authorize any deviation from the standard operating procedure.
Final report
The study director is responsible for the final report. He prepares and approves the final report. The key elements of a final report are:
- Study director’s GLP compliance statement
- Interpretation of crucial discussions and study results
- Any deviation from standard operating procedures
- Accurate and complete account of the study
Storage of records
The study director is responsible for capturing and storing all data related to the study of interest. These documents and records are later archived and stored at the end of the study. Only staff members authorized by the facility manager should be able to access these records and documents. Besides, laboratories must log every instance of access, removal, or return of these records. Additionally, regulatory bodies recommend indexing of archives.
Conclusion
Compliance with good laboratory practices in toxicology laboratories is essential for scientific credibility and regulatory acceptance in drug development. Hence, a systematic implementation of GLP bioanalysis and Assay Testing is necessary for biotechnology and pharmaceutical companies.
A comprehensive GLP strategy ensures data integrity and successful regulatory submissions in toxicity assessments. Today, understanding the strategic potential of GLP compliance is essential for accelerating timelines and augmenting competitive positioning.
