Good Laboratory Practice (GLP) differs from Good Manufacturing Practice (GMP) in a fundamental way. GLP deals with preclinical development, while GMP has to do with manufacturing. That is, while GLP concerns itself with study, GMP is all about the method, i.e., the process.
GLP are a set of regulations for conducting nonclinical laboratory studies, and are not a set of guidelines. GLP is covered under 21 CFR Part 58, and regulate nonclinical laboratory studies that support or intend supporting applications for research or marketing permits for certain classes of products. These include:
- Food and color additives
- Human and animal drugs
- Medical devices for human use
- Biological products and electronic products that are regulated by the FDA.
Joy McElroy, Principal Consultant at Maynard Consulting Company, will, at a marathon four-hour session being organized on March 25 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, explain all the aspects of GLP while giving clarity on how it differs from GMP.
Please visit globalcompliancepanel to register for this important learning, at which the following areas will be covered:
- What are Good Laboratory Practices
- Why were they created
- What is 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
- Disqualification and Reinstatement
This webinar is being organized for the benefit of personnel that deal with GLP and GMP in the course of their work, and include Quality Assurance Personnel, Quality Control Personnel, Research and Development Personnel, Regulatory Affairs Personnel, Project Managers, Manufacturing Managers, Validation Engineers, Internal Auditing Personnel, Microbiology Personnel, and Auditors.
About the expert:
With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.
Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.