What is GLP inspection?

What is GLP inspection?

One of the fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies.

What are GLP requirements?

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 is GLP documentation?

Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.

What does 40 CFR 160 refer to?

40 CFR 160: EPA Good Laboratory Practice Standards.

What are four pillars 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.

Why is good laboratory practice important?

Good lab practice prevents isolated internal incidents that could have catastrophic implications outside the four walls of the facility, such as cross-contamination, chemical leaks and infection.

What are examples of 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.

How do you get GLP certified?

For the GLP certification, you must take three core courses on good laboratory practices, writing process documents and clinical trial project management and one elective with varying topics.

What are 5 good laboratory practices?

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 and reference items.
• Standard operating procedures.
• Performance of study. Study Plan.

Is Good Laboratory Practices (GLP) a law?

• Good Laboratory Practices has been made as law by introducing it as Schedule L-1 which is a New Schedule under Drugs and Cosmetics Rules, 1945 vide Gazette notification no GSR 780 (E ) 10-11-2008 with effect from 1-11-2010. Consequent to this amendment, Rule 74, 78 and Rule 150E of the Drugs and Cosmetics Rules, 1945 have been amended.

What are good clinical laboratory practices (GCLP)?

DAIDS has determined that Good Clinical Laboratory Practices (GCLP) are the minimal requirements that clinical research laboratories should follow, as GCLP embraces both the research/pre-clinical and clinical aspects of Good Laboratory Practices (GLP).

What are the SOPs for GLP inspectors?

These SOPs are the primary guidance documents developed by EPA to inform GLP inspectors of current policy and procedures. As such, all current SOPs will take precedence over the contents of this manual. In areas where this manual and newer SOPs differ, the directives of the SOPs will be followed.

What is the purpose of Die GLP standards?

The purpose of die GLP standards is to provide some assurance that studies are conducted with certain safeguards in place regarding data quality and integrity and that the raw data, records, and reports will allow a study’s reconstruction. GLP Inspection Manual 1-2