GxP series industry standards (GLP / GCP / GMP)
GxP (Good Practice) is a globally recognized quality assurance system for medicines. The GxP system covers all stages of the life cycle of a medicinal product from pharmaceutical development, testing, manufacturing, storage to end-user use, namely:
- Preclinical (laboratory) studies regulated by the GLP (Good Laboratory Practice) Rules,
Clinical trials regulated by the GCP (Good Clinical Practice)Rules, - Production regulated by GMP (Good Manufacturing Practice)Regulations,
- Storage that is regulated by the GSP (Good service Practice, good service practice, storage)rules,
- Wholesale trade regulated by the GDPR (Good Distribution Practice)rules,
- Retail trade regulated by the GPP (Good Participatory Practice) rules.
GLP. Good laboratory practice
GLP (Good Laboratory Practice) is a quality system covering the organizational process and conditions under which non-clinical studies of medicinal products related to health and environmental safety are carried out.
GLP rules include:
- requirements for organizing tests;
- requirements for researchers ‘ personnel;
- requirements for premises where tests are carried out and animals are kept;
- requirements for the quality of animals, their conditions of keeping and feeding;
- requirements for laboratory equipment and its calibration;
- test and control substance requirements;
- requirements for drawing up and conducting a detailed standard methodology for experimental work and for the
- procedure for conducting tests;
- requirements for data registration and report design;
- requirements for the Test quality control service;
- standard methods of experimental work.
GСP. Good clinical practice
GCP (Good Clinical Practice) is an international ethical and scientific standard for planning and conducting research involving a person as a subject, as well as documenting and presenting the results of such research.
The GCP rules are designed to ensure the reliability of clinical trial results, as well as the safety and health of people participating in these trials as subjects.
GMP. Good manufacturing practices
GMP (Good Manufacturing Practice) is an international standard that establishes requirements for the production and quality control of medicines for humans and animals, as well as special requirements for the production of active pharmaceutical substances and certain types of medicines. The GMP standard regulates and evaluates production and laboratory testing parameters.
Benefits of implementation and certification:
- improving the quality and evidence of preclinical and clinical trials in the development of new active pharmaceutical substances (APS) and medicinal products (medicines);
- ensuring the quality, safety and effectiveness of medicinal products (drugs) and active pharmaceutical substances (APS) in their production;
- improving the organization’s image, demonstrating commitment to international standards, best practices and product quality, as well as compliance with current legal and regulatory requirements;
ensuring the economic stability of the organization in the existing market of manufacturers of medical devices and the ability to enter new sales markets; - increasing the commercial value of products from the point of view of greater consumer confidence and, as a result, increasing sales;
- promotes successful participation in tenders and tenders for the supply of the organization’s products;
- clear creation of the organization’s business processes, effective distribution of internal resources, responsibilities and powers of personnel within the existing management system;
- the possibility of exporting many types of medicines to the EU countries.