Instructor: Fahad Khan Tareen

Good Laboratory
Practice (GLP)
FDA Guidelines
 Introduction
GLP is a formal legally defined term that encapsulates the practice of
using a standardized set of guidelines to generate reproducible results
that can be validated by replicating experimental conditions.
GLP is an essential ingredient for any professional scientist
 Brief History
• In the mid-1970s, FDA reached the alarming conclusion that the
proof of the safety of many regulated products was based on invalid
studies.
• After convening a joint task force that included the FDA, the US
Congress, the public, and industry as formal stake holders, GLP
regulatory requirements for assuring a study’s validity were finally
proposed on November 19, 1976.
 Definition
GLP is a set of guidelines that govern the process, organization, and
conditions under which laboratory studies are conducted.
GLP is defined by principles that provide a framework within which
laboratory studies are planned, performed, monitored, recorded, reported,
and archived.
 Scope
GLP provides an assurance to regulatory authorities that the data
submitted are a true reflection of the results and can be relied upon
while making risk/safety and efficacy assessments.
What are non-clinical safety studies?
The definition of a nonclinical laboratory study “means in vivo or
in vitro experiments in which test articles are studied
prospectively in test systems under laboratory conditions to
determine their safety.”
Non-Clinical Testing Facility
What are the requirements to start and run a testing facility?
 Organization and Personnel
For non-clinical testing laboratory

Personnel are defined as each individual engaged in the conduct of or responsible for the
supervision of a nonclinical laboratory study.

1. Each member will have education, training, and experience to conduct the assigned
functions.
2. Each testing facility has to maintain a current summary of training and experience for each
member engaged in or supervising the conduct of a nonclinical laboratory study.
3. There must always be a sufficient number of personnel for the timely and proper conduct of
the study according to the protocol.
4. All personnel are required to take appropriate health and safety precautions and be free of
medical conditions that would have an adverse effect on a nonclinical laboratory study.
Management of the Testing Facility
Each nonclinical laboratory is required to have a study director and a quality
assurance unit (QAU).
What are the responsibilities of a
study director?
Quality Assurance Unit (QAU)
• Serve an Internal control function.
• It is responsible for monitoring each study to assure management
that facilities, equipment, personnel, methods, practices, records,
controls, SOPs, final reports (for data integrity), and archives are in
conformance with the GLP regulations.
• For any given study, the QAU is entirely separate from and
independent of the personnel engaged in the direction and conduct
of that study.
 Prime Responsibilities of QAU
1. Maintain a copy for all studies. This includes a description of the study to be conducted,
the objectives and design of the study, the date when the study is initiated, the current
status of each study, identity of the sponsor, and name of the study director.
2. Maintain copies of all protocols pertaining to the studies for which QAU is responsible.
3. Inspect the documentation for each study periodically to ensure the integrity of the study
with respect to internal laboratory activities. Properly written and signed records of each
periodic inspection must be maintained. The records must include the date of the
inspection, the study inspected, the phase or segment of the study inspected, the
person performing the inspection, findings and problems, action recommended and
taken to resolve existing problems, and any scheduled date for reinspection.
4. Determine whether deviations from protocols and SOPs were made with proper
authorization and documentation.
5. Review the final study report to assure that it accurately describes the methods and
SOPs and that the reported results accurately reflect the raw data of the study.
6. Prepare and sign a statement to be included with the final study report that specifies the
dates of audits and dates of reports to management and to the study director.
7. Audit the correctness of statements, made by the study director, on GLP compliance of
the study.
8. Audit laboratory equipment.
Thank you