GLP Certificate
The GLP Certificate is given to laboratories that meet the Good Laboratory Practices criteria. GLP (Good Laboratory Practices) covers all technical and administrative work carried out in a laboratory, the quality assurance system established, the documentation structure and many more. All units that carry out laboratory studies on products such as cosmetics, pesticides, veterinary medicinal products, food additives, animal feeds, industrial chemicals, etc. can obtain GLP Certificate. The GLP Certificate ensures that laboratory studies are carried out within the framework of a quality management system and that accurate, effective and safe data is produced. Laboratories holding the GLP Certificate work in compliance with the principles of Good Laboratory Practices in many areas such as test equipment, personnel competency, work performance, reporting and recording.
What is GLP Certificate?
With the development of technology, the scope of scientific studies on human, animal and environmental issues has also expanded. At the center of all these studies are the researches, tests and analyzes carried out in the laboratories. In order to develop the right products for human, animal and environmental health, and to produce accurate and reliable test data for this, laboratory units must work in certain quality standards. Good Laboratory Practices also refer to the principles developed to ensure this.
In our country, the "Principles of Good Laboratory Practices, Harmonization of Test Units, Regulation on the Inspection of Good Laboratory Practices and Studies" published by the Ministry of Environment and Forestry in the Official Gazette No. 27516 on March 9, 2010, also created a legal basis for the GLP and GLP Certificate processes. This regulation ensures that the test units that carry out laboratory studies on the products within the scope comply with the GLP principles; It explains the procedures and principles related to the GLP Certificate.
The Good Laboratory Practices criteria that a laboratory wishing to obtain a GLP Certificate must meet are shaped around the following headings:
1. Test Unit Management and Personnel
o Responsibilities of Test Unit Management
o Responsibilities of the Study Manager
o Responsibilities of the Chief Officer
o Responsibilities of Working Personnel
2. Quality Assurance Program
o Responsibilities and Audits of Quality Assurance Personnel
3. Test Unit
o Test System
o Test and Reference Items
o Archive
o Waste Disposal
4. Devices, Materials and Reagents
5. Test Systems
o Physical / Chemical
o Biological
1. Test and Reference Items
o Reception, Handling, Sampling and Storage
o Characterization
2. Standard Operating Procedures
3. Working Performance
o Study Plan
o Content of the Study Plan
o Execution of Studies
4. Reporting Study Results
o Content of the Final Report
5. Retention and Storage of Records and Materials
How to Get GLP Certificate?
The institution authorized to issue GLP Certificate in our country is the Turkish Accreditation Agency (TÜRKAK), which is declared as the national ILU (Good Laboratory Practices) monitoring authority in the regulation. TÜRKAK conducts conformity inspections and certification of test laboratories; In case it deems necessary, it can withdraw or limit the authorizations of the units to which it has given GLP Certificate. In this context, organizations that want to obtain a GLP Certificate must apply to TÜRKAK after making the necessary preparations within their own body.
TÜRKAK requests certain documents the applicant laboratory unit and examines these documents before the GLP certification audits. In this context, laboratories are required to prepare and submit documents such as employee information, quality management system, work instructions, organizational structure, devices used, calibration system, laboratory registration form, etc. to TÜRKAK. After TÜRKAK approves the conformity of these documents, it assigns independent auditors for laboratory inspection. Inspectors visiting the laboratory inspect the unit´s compliance with Good Laboratory Practices requirements on site. If a situation contrary to GLP principles is detected, it requests the laboratory management to develop corrective action. After the implementation of these activities, the certification process is completed by giving the GLP Certificate to the laboratory.
GLP Certificate Benefits
We can list some of the versatile benefits of the GLP Certificate as follows:
o Producing accurate and reliable test results
o In this way, to ensure the protection of human, animal and environmental health
o To be able to adapt to national and international legal regulations much more quickly and easily
o To increase the trust of stakeholders, who are the addressees of laboratory data, in laboratory studies and data
o Increasing corporate reputation
o Increasing efficiency and productivity in laboratory work
o Thanks to the internationally valid GLP Certificate, it is subject to repetitive audits and verification studies.
GLP Certificate Training and Consultancy
Obtaining a Good Laboratory Practices Certificate means meeting many requirements at the same time. In this process, laboratory units need to make many arrangements, both technically and administratively. If all these are not done under the supervision and accompaniment of an expert, many problems may arise. This means both a waste of time and a monetary loss. For this reason, it is recommended that laboratory businesses receive support a consultancy firm in this process. In this way, work on the GLP Certificate can be completed quickly, accurately and easily. Thanks to the training and consultancy services, the units that complete the necessary preparations as soon as possible can skip the certification process very quickly. Problems that arise during the process can be resolved as soon as possible thanks to the expertise of the companies that provide GLP Certificate consultancy.
