What is GLP and its principle?

The Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived).

What is GLP in quality assurance Slideshare?

GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978. 3. Definition of GLP • GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.

What is the importance of GLP?

In the pharmaceutical industry, GLP regulations are the standard used to assure the quality and integrity of nonclinical drug safety studies conducted in animals. GLP regulations were first introduced by the FDA in 1978 and have become an integral part of nonclinical drug development.04-Aug-2021

What are four pillars of GLP?

GLP principles include

Management-Responsibilities.
Sponsor-Responsibilities.
Study Director-Responsibilities.
Principal Investigator-Responsibilities.
Study Personnel-Responsibilities.

What are the basic elements of GLP?

The components of Good Laboratory Practice are presented under the headings: type of laboratory work, discipline, management, personnel, premises, safety, equipment, reagents, standard operating procedures, internal quality control, external quality assessment, method, dedicated operating procedure, syllabi, and

What is the scope of GLP?

SCOPE OF GLP  The scope of GLP as it is defined in the OECD Principles, and which states that GLP encompasses: “the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals 14-Sept-2015

What is GLP in quality assurance?

"Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.06-May-2022

Who is GLP?

Good laboratory practice regulations (GLP) became part of the regulatory landscape in the latter part of the seventies in response to malpractice in research and development (R&D) activities of pharmaceutical companies and contract facilities used by them.

What are good laboratory work practices?

Safe Lab Practices

No Food or Drink.
Wear Your PPE and Proper Lab Attire.
Good Hygiene.
Use Proper Storage Containers.
Label Your Work Space.
Don't Work Alone.
Stay Focused and Aware of Your Surroundings.
Participate in Safety Exercises.

When was GLP introduced?

The GLP regulations were proposed in 1976, becoming effective in 1979. The OECD developed the principles of GLP in order to enable European countries to accept each other's work.

Who regulates GLP?

The body which monitors the compliance of the regulations is the UK GLP Monitoring Authority. The Regulations require that any test facility which intends to conduct regulatory studies must be a member of UK GLP Compliance Monitoring Programme.11-Nov-2011

What are the 10 lab rules?

The 10 Most Important Lab Safety Rules

of 10. The Most Important Lab Safety Rule.
of 10. Know the Location of Safety Equipment.
of 10. Dress for the Lab.
of 10. Don't Eat or Drink in the Laboratory.
of 10. Don't Taste or Sniff Chemicals.
of 10. Don't Play Mad Scientist in the Laboratory.
of 10. Dispose of Lab Waste Properly.
of 10.

What is GLP documentation?

The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived.

What are 5 safety precautions for a laboratory?

Basic Safety Rules

Know locations of laboratory safety showers, eyewashstations, and fire extinguishers.
Know emergency exit routes.
Avoid skin and eye contact with all chemicals.
Minimize all chemical exposures.
No horseplay will be tolerated.
Assume that all chemicals of unknown toxicity are highly toxic.

Who started GLP?

3. HISTORY  GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978.

In which country GLP was first introduced?

GLP was first introduced in New Zealand and Denmark in 1972.09-Aug-2013

What is GLP data?

Good Laboratory Practice (GLP), are federal regulations that require implementation of a robust quality management system to ensure the validity, integrity and reliability of non-clinical safety data submitted for regulatory evaluation and approval.06-Dec-2018

What is GLP audit?

GLP Audits: Assessment of laboratories, records, facilities, test articles, test systems, facilities, chain of custody. for compliance with GLP regulations. Laboratory evaluation (personnel training and records, materials, experimental or analytical documentation, etc.)

What is the first rule of lab safety?

1. Wear protective lab attire: Make sure you use PPE at all times inside the laboratory. Put on a lab coat with full sleeves, closed-toe shoes, and safety goggles before entering the lab. If you have long hair, it's better to keep it tied and out of the way when working in the lab.27-Feb-2020

What is safety rules?

Definition. A principle or regulation governing actions, procedures or devices intended to lower the occurrence or risk of injury, loss and danger to persons, property or the environment.

What is lab safety Rule #3?

RULE #3: HANDLING CHEMICALS Wear gloves whenever pouring chemicals or handling them. If there is a spill be sure to let the teacher know. If you have to dispose of chemicals, always use the waste containers provided on your lab tables.

What is GLP and its principle?