February 11, 2021
What are the GLPs?
In the United States, Good Laboratory Practice, aka “the GLPs”, describes FDA regulation 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. This regulation is for in vivo or in vitro experiments where test articles (such as medical devices, biological products, pharmaceutical products, or any other article subject to regulation under the Food, Drug, and Cosmetic Act or as described under the Public Health Service Act) are tested before use to determine their safety. The regulation applies to the conduct of nonclinical laboratory safety studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA. Nonclinical may also be referred to as preclinical. The regulation describes structural requirements for an organization performing GLP studies, such as for personnel, facilities, operations, and records.
A GLP study requires the use of a protocol approved by the Sponsor and signed by the Study Director prior to the start of the study. Each GLP study is conducted by trained personnel with the use of calibrated and/or qualified instruments and equipment. The data collected during the conduct of the study is attributable, legible, contemporaneous, original, and accurate. Traceability of changes is necessary for all documentation including, protocols, data, and reports. Each study is reproducible and allows for an independent scientific review. GLP studies also require in-process audits by Quality Assurance at appropriate intervals to assure Standard Operating Procedures and protocols are being followed. Detailed reports are generated that reflect the data and include the Study Director’s scientific assessment of the objectives of the study. The data and reports are reviewed by Quality Assurance, and the reports include a Quality Assurance Statement. Each GLP report also includes a GLP Compliance Statement signed by the Study Director, attesting to the regulatory status of the work performed.
Other GLP regulations and guidance documents exist both within the United States (EPA) and in other countries, such as other OECD member countries, China, and India. Many countries certify laboratories as “GLP”. However, compliance to FDA GLP is determined on a study-by-study basis, not on an organizational basis. Therefore, US laboratories are not certified as “GLP”.
GLP regulations are designed to provide regulatory guidance and oversight of nonclinical studies that prospectively study the effects of test articles in test conditions to determine their safety. These regulations are designed to assure quality, accountability, and reliability of safety data of the studies conducted. A GLP study is designed, conducted, and reported to assure quality and, the Study Director ensures proper technical conduct, interpretation, documentation, and analysis of the results that can be submitted to the FDA and other international regulatory agencies. For more definitive information on GLP guidelines and other FDA requirements, go to FDA.com
Author – Felice Randi LaMadeleine, Quality Assurance Manager
N.A.(2021) FDA.com “Code of Federal Regulations: Title 21” Retrieved from: CFR – Code of Federal Regulations Title 21 (fda.gov)