Question 1

What is the Meaning of Good Laboratory Practice (GLP)?

Accepted Answer

Good Laboratory Practice (GLP) defines a regulatory framework for non-clinical laboratory studies, primarily for safety assessments of test items like pharmaceuticals or chemicals. It sets standards for the planning, execution, monitoring, recording, archiving, and reporting of these investigations. The core objective is to assure the quality, integrity, and reliability of data submitted to regulatory authorities.

Question 2

What is the Context of Good Laboratory Practice (GLP)?

Accepted Answer

GLP operates within the preclinical phase of product development, preceding human administration in clinical trials. It applies to studies generating data on hazards and risks to humans, animals, and the environment. This system forms a critical scientific basis for new substance safety evaluation, supporting the transition from laboratory research to human application.

Question 3

What is the Significance of Good Laboratory Practice (GLP)?

Accepted Answer

The practical importance of GLP is foundational for patient safety, assuring the non-clinical data upon which human trials rely. Reliable safety data prevents erroneous conclusions regarding product profiles, protecting individuals from harmful exposures. This regulatory adherence directly impacts public health outcomes by ensuring only thoroughly tested compounds advance to human use.

Question 4

What is the Mechanism of Good Laboratory Practice (GLP)?

Accepted Answer

GLP functions through systematic application of quality principles across all laboratory operations. This includes stringent requirements for personnel, facility suitability, equipment calibration, detailed standard operating procedures, and comprehensive documentation of activities. A robust quality assurance program systematically monitors adherence, minimizing variability and enhancing data trustworthiness.

Question 5

What is the Application of Good Laboratory Practice (GLP)?

Accepted Answer

GLP principles guide contract research organizations, pharmaceutical companies, and governmental research institutions conducting safety studies for regulatory submission. These guidelines dictate toxicology, pharmacology, and other non-clinical investigations. They ensure all steps, from test item receipt to final report generation, are meticulously controlled and documented, facilitating traceability and reproducibility.

Question 6

What is the Metric of Good Laboratory Practice (GLP)?

Accepted Answer

Compliance with GLP is assessed via regular inspections and audits by national and international regulatory bodies. Inspectors review study protocols, raw data, facility records, and quality assurance reports to verify adherence. Identified deviations necessitate prompt corrective and preventative actions to maintain the laboratory's compliant status, essential for data acceptance.

Question 7

What is the Risk of Good Laboratory Practice (GLP)?

Accepted Answer

Non-compliance with GLP carries substantial risks, including rejection of safety data by regulatory agencies. This leads to significant product development delays, increased costs, or even abandonment of a therapeutic agent. Unreliable safety data could permit unsafe products to market or impede beneficial therapies due to unverified concerns, posing direct public health risks.

Good Laboratory Practice (GLP)

Meaning

Context

Significance

Mechanism

Application

Metric

Risk

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