GLPs And GMPs: When Are They Necessary?

By Don DeRoo, Director of Quality Assurance and Regulatory Affairs, NAMSA Laboratory Services Division

Testing of FDA-regulated products may be performed under different regulations, including Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). This white paper outlines the differences between GLP and GMP regulations that are significant to testing, and provides guidance on when these regulations are applicable.

GMPs are the minimum practices, processes, and standards required for manufacturing, packaging, testing, storage, and distribution of drugs, biologics, human cells, tissues, cellular and tissue-based products (HCT/P), certain Class I medical devices, and all Class II and III medical products. These practices assure that the applicable regulatory requirements for safety, identity, strength, quality, and purity are met, and that the product is appropriate for its intended use. GMPs apply to marketed products and, depending on the stage of development, products used in clinical trials. The FDA GMPs for human medical products are defined in the following sections of 21 CFR:

• Drugs – Parts 210 through 211
• Biologics and blood products – Parts 600 through 680
• Medical devices – Part 820
• HCT/P – Part 1271

GLPs are a set of principles and requirements for planning, executing, monitoring, recording, reporting, and archiving nonclinical laboratory studies. These studies are performed to generate data for determining the safety of medical products. Testing under GLPs helps assure regulatory authorities that the data submitted in research or marketing applications accurately reflect the result obtained during studies, and that it can be relied upon in making risk/safety assessments. For the purposes of this document, references to GLP requirements refer only to those applicable to FDA-regulated products. Tests/studies that are not specifically performed to determine product safety and do not utilize a live organism as the test system do not require performance under GLPs. The FDA GLPs are defined in 21 CFR Part 58.