GLP: Good Laboratory Practices

Question 1

What is GLP?

Answer 1

• A set of regulations to ensure QUALITY and INTEGRITY of DATA
• Governs how studies are planned, performed, monitored, recorded and reported

Question 2

When is GLP requried?

Answer 2

Any preclinical/nonclinical study supporting the assessment of safety pharmacology or toxicology for obtaining FDA research or marketing permits.

Question 3

What are GLP requirements?

Answer 3

o Independent QA unit oversight
o All work and operation must follow written SOPs
o Responsibilities defined for sponsor management and study management
o Test article (and vehicle) must be fully characterized (identity, purity, stability, homogeneity, and concentration)
o Instruments must be calibrated and maintained
o All personnel must have records of proper training
o Raw data must be archived

Question 4

What types of products do GLP regulations govern?

Answer 4

• Food and color additives
• Human and animal drugs
• Medical devices for human use
• Biological products
• Electronic products

Question 5

What is the Act relevant to GLP regulations?

Answer 5

Federal Food, Drug, and Cosmetic Act (1938), as amended

Question 6

Test Article

Answer 6

Any products that are subject to regulation under the FD&C Act or the Public Health Service Act

Question 7

Control Article

Answer 7

Whatever you are comparing the test article to

Question 8

Nonclinical Laboratory Studies

Answer 8

In vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety

Question 9

What do nonclinical laboratory studies NOT include?

Answer 9

o Studies utilizing human subjects
o Clinical studies or field studies in animals
o Basic exploratory studies

Question 10

Application for research or marketing permit

Answer 10

• Food or color additive petitions
• Investigational new drug (IND) application = gateway to clinical trials
• New drug application (NDA) = application for FDA approval for sales and marketing in U.S.
• New animal drug application
• Application for a biologics license
• Application for an investigational device exemption
• Application for premarket approval of a medical device
• Product development protocol for a medical device

Question 11

Sponsor

Answer 11

• Initiates and supports a nonclinical laboratory study
• Submits a nonclinical study to FDA in support of an application for research or marketing permit
• Can be the testing facility, if it both initiates and conducts the study

Question 12

Testing Facility

Answer 12

Facility that actually conducts the nonclinical laboratory study

Question 13

Test System

Answer 13

Animal, plant, organism, etc. to which the test material is administered

Question 14

Raw Data

Answer 14

Anything that is the result of original observations and activities of a nonclinical laboratory study
• Necessary for the reconstruction and evaluation of the report
• May include photographs, microfilm, printouts, magnetic media, recorded data from automated instruments

Question 15

Quality Assurance Unit

Answer 15

Organizational element designated by the testing facility to perform QA duties
• Responsible for monitoring each study to ensure compliance with regulations
• Must be entirely separate and independent of the personnel engaged in the direction and conduct of the study

Question 16

Study Director

Answer 16

Individual responsible for the overall conduct of nonclinical laboratory study
• Scientist or other professional of appropriate education, training, and experience