What are GLP guidelines?
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 considerations do you have to make for GLP and ELP is required?
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.
What is national compliance monitoring authority?
National GLP Compliance Monitoring Authority (NGCMA) was established by the Department of Science & Technology (DST), Government of India, with the approval of the Union Cabinet on April 24,2002. India is full-member for Mutual Acceptance of Data (MAD) in the OECD’s Working Group on GLP w.e.f March 3, 2011.
What is the validity period of GLP certification in India?
three years
GLP-compliance certification shall be valid for a period of three years.
What are examples of good laboratory practices?
Good Laboratory Practice Examples
- Wear Personal Protective Equipment (PPE) at all times.
- Communicate with other members of the research lab.
- Participate in refresher training and safety exercises.
- Be aware of what you’re doing at all times.
- Pay attention to unfamiliar smells and substances.
What is required for good laboratory practice?
The 10 Good Laboratory Practice principles are:
- Test Facility Organization and Personnel.
- Quality Assurance Programme.
- Facilities.
- Apparatus, Material, Reagents.
- Test Systems.
- Test and Reference Items.
- Standard Operating Procedures.
- Performance of the Study.
What are the two main goals of the GLPs?
What are the two main goals of the GLPs? To make life difficult for study personnel. To ensure accountability. To ensure ability to reconstruct the study.
What is GLP PPT?
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 GLP in pharma?
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health ( …
How can I get GLP certification in India?
The Annual Certification fee has been fixed at Rs. 25,000/- In case a GLP certified test facility wishes to add area(s) of expertise during a certification cycle, it is requested to submit an application in prescribed Application Form specific to the area(s) along with requisite fee.