GLP is a system that describes good laboratory practices, the coordination, analysis and control of factors affecting health and the environment, apart from clinical studies, and reporting. This laboratory application system, which takes place in many areas of our lives, is extremely necessary for chemical products, especially food products.
The process works by making the necessary examinations, analyzing and filtering. Thus, better products for human life are produced and a flawless system operation takes place.
How Does the GLP Good Practices System Certification Process Work?
The GLP good laboratory practices system certification process operates within the scope of the GLP regulation. The GLP regulation needs a fairly broad definition. This regulation tests food additives applied to humans and animals, products used for medicine, cosmetic products, substances applied to prevent, control or eliminate harmful organisms, additives used in feed and heavy chemicals used in industrial applications and similar products from various aspects. Includes related work. In addition, coordinating the test studies, keeping the necessary records and examining the test conditions for reporting are also within the scope of the regulation.
It covers the applications of test units in various companies in accordance with the scope of this regulation or laboratories established only for the realization of this work. It is discussed within the scope of whether it complies with the GLP Good Laboratory Practices network standards.
The required compliance examination of the companies in question is carried out in accordance with the national monitoring program to be prepared by the National ILU Monitoring institutions. This regulation also clearly and unequivocally explained that the relevant authorities, as the National ILU Monitoring Institution, have legal competence.
What are the Documents Required for GLP Good Laboratory Practices Application?
In order for each document to be obtained from the required institutions, some necessary steps must be followed. The situation is no different for the GLP good laboratory certificate. In order to obtain the said document, the application form must first be filled in by the laboratory.
In addition, it is indispensable for the laboratory to have a commercial registry and a legal status. It is not possible for a laboratory that does not meet this requirement to receive the said document. Another thing required in the application process is the GLP good laboratory practice review form. In addition to this, the basic working principle of the laboratory should also be reported. Apart from these
- Training documents of the Laboratory Manager, Quality Assurance Officer and Study Manager are required.
- A list showing the areas where the employees are assigned, their titles, experience periods and signature samples should be prepared.
- Organization and layout chart of the laboratory is required.
- A list of documents included in the quality network
- All instructions on good laboratory activities
- A list of tools and equipment is required.
- Summary information about the studies concluded by the laboratory is required.
- GLP Good Laboratory Practices Establishment Officer Notification Form is required.
- GLP Good Laboratory Practices Analysis Form is required.
- GLP Good Laboratory Practices Compliance Monitoring Program
What are the Advantages of GLP Good Laboratory System Certificate?
Today, chemicals are used in many areas of life. Even at the present stage, this is a serious necessity. By ensuring that the quality of the test data for the clear determination of the effects of these chemicals on human health and the environment is comparable and acceptable between countries, it limits unnecessary test repetitions, the use of experimental animals and saves time. In addition, it provides the necessary standards for quality in the treatment of industrial substances.
In addition to all these, the GLP good laboratory practices system is used in non-clinical safety studies for drug development, in the development of biocides, in the development of pesticides used for agriculture, in the production of toxic chemicals, in the development of additives suitable for foods, in testing studies of explosive substances and in the development of cosmetic products. used.
What are the Goals of the GLP Good Laboratory System?
Good Laboratory Practices (ILU) is a quality system in which health and environmental safety studies are planned and carried out, except for the clinic. In addition, monitoring, recording, archiving and reporting are done. The examination of products used in the cosmetics industry, products made by humans or by veterinarians is also within the scope of good laboratory studies. In addition, additives used in food, feed