RAC Chapter 8 - GLP Regulations

Which two acts impose the burden on manufacturers of demonstrating that their products meet the safety and effectiveness requirements of the law and that products are not misbranded?

Which other two entities have a set of principles similar to that of the FDA's GLPs?

What CFR prescribes good laboratory practices for conducting non-clinical laboratory studies?

Which ONE of the following is included in non-clinical laboratory studies?

Which of the following studies is subject to GLP testing?

Job qualifications are defined by laboratory management and the CFR regulations.

Which personnel type is responsible for the inspection of facilities on a schedule defined by SOPs to ensure GLP compliance?

Specific instructions given in the study protocol supersede SOPs.

A ______ means any food additive, color additive, drug, bio-pharmaceutical, biological product, medical device, or electronic product intended for human use.

Which of the following is not required when making changes to data?

A GLP statement of compliance is required to be included in a study report.

In what case would an animal cage card be considered raw data?

What are the 4 types of GLP and nonclinical lab related inspections?

In the case of GLP deviation letters, how long do companies have to respond to the FDA?

All chemicals in the lab must be labeled for identity, storage conditions, and expiration dates.

What was the most frequent citation issued in FDA warning letters related to GLP violations?

GLP Regulations Overview

Burden of proof for product safety and effectiveness falls under the Federal Food, Drug and Cosmetic Act (FD&C) and the Public Health Service Act.
Similar GLP principles exist in the Organization of Economic Cooperation (OECD) and the Japanese Ministry of Health, Labor, and Welfare (MHLW).

Code of Federal Regulations

Good Laboratory Practices (GLPs) for conducting nonclinical laboratory studies are outlined in 21 CFR 58.

Nonclinical Laboratory Studies

In-vitro experiments are included in nonclinical laboratory studies, while human subjects and field trials in animals are not.
Safety pharmacology studies are mandated to undergo GLP testing.

Job Qualifications and Compliance

Job qualifications are designated by laboratory management, as the CFR regulations do not define them.
The Quality Assurance Unit (QAU) is responsible for conducting facility inspections to assure GLP compliance, following schedules defined by Standard Operating Procedures (SOPs).

Study Protocols and Data Management

Specific study protocol instructions supersede SOPs.
A test article encompasses any product intended for human use, including drugs and medical devices.
When modifying data, secondary verification is not required; however, initials of the recorder, date of entry, and justification of change are mandatory.

Compliance Statements and Raw Data

Including a GLP statement of compliance in a study report is not required, but it is recommended.
Animal cage cards are considered raw data if they contain original observations.

Types of Inspections

GLP inspections include periodic inspections, data audits, directed inspections for questionable data, and follow-up inspections to ensure corrective actions are implemented.

FDA Response Guidelines

Companies are allotted 10 days to respond to FDA regarding GLP deviation letters.

Laboratory Chemical Labeling

All chemicals in the lab should ideally be labeled for identity, storage conditions, and expiration dates, although this is suggested, not a strict requirement.

Common GLP Violations

The most frequent citation in FDA warning letters pertains to failure of QAUs and study directors to fulfill their responsibilities.

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