Good Laboratory Practices (GLP) Requirements
Introduction and Objective of GLP
Good Laboratory Practice (GLP) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. The objective is not only quality of data but also traceability and integrity of data.
History of GLP
GLPs were established after FDA inspected several research laboratories during the mid 1970s, which revealed serious problems with the conduct of safety studies submitted to the agency.
In 1979, good laboratory practice (GLP) regulations became effective under 21 Code of Federal Regulations (CFR) Part 58.
Subsequently, during 1979 and 1981, FDA published two critical "Guidance for Industry" documents -- "Post Conference Report" and "Questions and Answers" -- to ensure proper and consistent interpretation of the regulations by the industry and FDA field investigators.
Applicability and Relation to other Regulations
GLPs regulate all non-clinical safety studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA.
Typically research and drug discovery are not regulated. GLP starts with preclinical development. Clinical trials are regulated by good clinical practice regulations. Manufacturing is regulated through GMPs.
GLP Key Requirements
According to GLP principles, at a minimum, GLP compliance requires the following:
- Assignment of study directors
- Establishment of a Quality Assurance Unit (QAU)
- Establishment of Standard Operating Procedures
- written protocol for each study
- Final report
GLP Inspections and Enforcement
The FDA has the responsibility to inspect GLP studies related to products that are marketed in the United States, it does not matter where the products are developed or manufactured.
- Two types of inspection programs
Routine inspections should be conducted at least every second year. It is an on-going evaluation of a laboratory’s compliance with GLP regulation.
For cause inspections are less frequent, they constitute only about 20% of all GLP inspections. Reasons for such inspections could be a follow up of an inspection with serious deficiencies or when the FDA suspect non-compliance when investigating NDA applications. It also may happen that the FDA gets some hints from external sources about non-compliance in laboratories.
- Enforcement
Deviations from GLP requirements are documented in different ways: if the inspection team finds deviations, they write them in a specific form 483. Then the lead inspector writes a full inspection report which is called: establishment inspection report. Depending on the deviations the inspector may or may not write a warning letter. This letter is sent to the company’s management. Within 14 days the company should respond with a corrective action plan.
Helpful Resources
GLPs are complex and could be confusing at times. Besides the 21 CFR part 58, the FDA has published guidance documents which consolidate all GLP questions answered by the agency. Below are listed some suggested resources for more information on Good Laboratory Practices:
- FDA regulation
21 CFR 58 -- Good Laboratory Practice for Non-clinical Laboratory Studies
- FDA Guidance for Industry
GLP Questions and Answers
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