What is GLP documentation?

GLP stands for Good Laboratory Practice. It is a quality control system used in research laboratories to: ensure data integrity (i.e. data is generated under high quality and reproducible conditions) avoid unnecessary repetition of studies. establish a common standard (in both laboratory practice and procedures)

What are GLP requirements?

GLP work requires at minimum 2 or 3 individuals. These are the person performing the work (analyst), a person reviewing the work (management), and a quality assurance reviewer (QA). If SOPs are written well, the analyst and the management can be the same individual; however, QA must always be an independent person.

What is GLP and why is it important?

GLP stands for Good Laboratory Practice, but what does this really mean? Good Laboratory Practice is designed to promote the development of quality test data and provide tools and methodologies that ensure a sound approach to managing laboratory studies.

What is GLP and example?

Good laboratory practice (GLP) ensures the safety, quality, and organization of pharmaceutical research. The practice is followed to maintain consistently high standards and comply with any regulations set by government agencies, internal company procedures, and international regulations, like the 3Rs.

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.

What GLP means?

Good Laboratory Practice
2.1. 1. Good Laboratory Practice (GLP) is 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, archived and reported.

What is the core objective of GLP?

The principles of GLP aim to ensure and promote safety, consistency, high quality, and reliability of chemicals in the process of non-clinical and laboratory testing.

Is GLP mandatory?

Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice ( GLP ) regulations when carrying out safety tests on: pharmaceuticals.

Why is GLP important in pharmaceuticals?

Why GLP is Important in Pharmaceuticals : Good Laboratory Practice contains different principles which are designed to ensure and promote consistency, quality, safety, reliability and integrity of chemicals during non-clinical and laboratory testing.

What is the purpose of GLP quality standard?

GLP ensures the quality and integrity of safety test data submitted to the government for the issuance of research permits.

What are the scopes of GLP?

Scope of GLP The Principles of Good Laboratory Practice (GLP) are defined as 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, archived and reported.

What is objective of GLP?

Purpose of GLP to avoid duplication of research; to improve the protection of human health and environment; to facilitate international acceptance of test data; to prevent the creation of technical trade barriers.

What are 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 are 5 good laboratory 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.

What are the components of GLP?

GLP principles include

• Organization and Personnel. Management-Responsibilities.
• Quality assurance program. Quality Assurance Personnel.
• Facilities. Test System Facilities.
• Equipment, reagents and Materials.
• Test systems. Physical/Chemical.
• Test & Reference items.
• Standard operating procedures.
• Performance of Study. Study Plan.