Presenting studies conforming to Good Lab Practice (GLP) is an essential regulatory requirement for drug approval by the FDA. These requirements were instituted to address a lack of consistency and quality of various chemicals, especially for the pharmaceutical, cosmetics, and the F&B industry. The GLP studies requirements are designed to ensure the robustness and safety of the data.
In the context of drug development, research and testing, the FDA requires submission of GLP-compliant study data along with New Drug Applications (NDA).
Understanding GLP Requirements
GLP requirements are important to the performance of nonclinical studies. These specific studies focus on the therapeutic as well as possible adverse effects of a drug or chemical. The safety of a drug must be assessed before human exposure or approval for clinical trials. Therefore, a GLP lab in a CRO or pharmaceutical company must follow prescribed practices to prove the safety of a drug. Once safety is established, the drug may also present the No Observed Adverse Effects Level (NOAEL) before clinical approval.
By their very nature and required thorough procedures, GLP studies can be expensive and time-consuming. This is why several parts of the non-clinical drug development can follow non-GLP procedures. Exploratory studies during drug development can be non-GLP as a way to reduce the financial and time burden on development.
GLP As A System
Ensuring Good Lab Practices is not a process, but it is a system to ensure data robustness with an expansive set of requirements. These requirements cover and extend to various parts of the GLP lab, personnel, and practices.
In this guide, we are covering some key requirements include:
- Study Director: The study director is necessary for each study conducted. The person handles scientific, regulatory, and administrative aspects of the study from beginning to end.
- Standard Operating Procedure (SOP): A SOP must be developed and followed in the laboratory. There must be sufficient adequately trained personnel in the laboratory to follow the SOP.
- Quality Assurance (QA) Unit: A separate Quality Assurance unit must monitor the study undertaken and submit reports, regularly and as specified. Their job is to ensure that SOP, as well as GLP practices, are meeting the requirements and standards set by the FDA and other regulatory authorities.
- Archiving and Storing Data: The test facility in question must have the requirements for archiving and storing data generated during the study. This storage period can last for 20 years.
- Test Articles: The test articles in a study must be fully characterized.
It is essential to set up or use a GLP lab which adheres to the standards laid down. Novices may This includes having an appropriate test facility to handle all research. Additionally, all necessary equipment must be well-maintained and calibrated.
Assessment And Effects Of GLP
The primary goal of GLP is to assess the accuracy of available data and the safety of the drug. Any application for Investigational New Drug (IND) application, should demonstrate the conduct of GLP studies on safety. These generally include in vivo and in vitro measurements to demonstrate the safety of the drug.
The studies conducted in bioanalytical laboratory generally include biocompatibility, DMPK studies, PK/PD studies, and tox studies.