According to the FDA, CFR part 58, good laboratory practices (GLPs) are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.
As per the FDA, GLPS are for non-clinical laboratory studies in which test articles are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals. GLPs are not enforceable by law. They do not include the manufacturing of the product. However, it is important to be able to compare and contrast GLPs with GMPs and understand their requirements.
Join this session, where expert speaker Joy McElroy will compare and contrast between good laboratory practices (GLPs) and good manufacturing practices (GMPs). She will discuss the objective behind GLPs and how they associate with GMPs and SOPs, and the consequences of non-compliance.
- Understanding good laboratory practices (GLP)
- GLP as an FDA regulation
- Definition of GLPs
- History of GLPs
- Why were GLPs created?
- Objectives of GLPs
- Mission of GLPs
- The objective of GLPs and how are they associated with GMPs and SOPs
- Statistical procedures for data evaluation
- Instrumentation validation
- Analytical and laboratory certification
- Documentation and maintenance of records
- Consequences of noncompliance
- Grounds for disqualification
- Reinstatement of a disqualified facility
- Regulatory Affairs Departments
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Manufacturing Departments
- Operations Departments
- Production Departments
- Documentation Departments
- Validation Teams
- Project Managers
- Engineering Departments
- Internal Auditing Personnel
- Microbiology Personnel
- Laboratory Personnel