GLP (Good Laboratory Practice) is a quality system which covers the organizational process and conditions under which non-clinical research of pharmaceuticals related to health and environmental safety is carried out.
GLP rules include:

• requirements for arrangement of tests;


• requirements for research personnel;


• requirements for facilities where tests are carried out and animals are managed;


• requirements for quality of animals, conditions of animal management and nutrition;


• requirements for laboratory equipment and its calibration;


• requirements for tested and reference substances;


• requirements for development and conduction of standard experimental activity methodology and for test procedure;


• requirements for registration of data and report preparation;


• requirements for test quality control service;


• standard methodologies of experimental activity.

GCP (Good Clinical Practice) is an international ethic and science standard for planning and conduction of research with a human subject, as well as for documenting and provision of research results.
GLP rules are intended to ensure credibility of clinical test results, as well as safety and protection of human rights and health of those who are subject to such testing.
The RF national equivalent of GCP is the standard GOST R 52379-2005 “Good Clinical Practice”, text of which is identical to GCP.

GMP. GOOD MANUFACTURING PRACTICE

GMP (Good Manufacturing Practice) is an international standard which establishes the requirements for manufacture and quality control of human and animal pharmaceuticals, as well as special requirements for manufacture of active pharmaceutical substances and certain types of pharmaceuticals. GMP standard regulates and evaluates parameters for manufacture and laboratory check.
The RF national equivalent of GMP is the standard GOST R 52249-2009 “Rules of manufacture and quality control of pharmaceuticals”, text of which is identical to GMP.

BENEFITS FROM IMPLEMENTATION AND CERTIFICATION

• opportunity to export many types of pharmaceuticals into the European Union countries;


• improved image of an organization which demonstrates commitment to the requirements of international standards, best practices and product quality, as well as compliance with applicable legal and regulatory requirements;


• ensured economic sustainability of an organization at the current market of medical devices manufacturers and opportunity to enter new markets;


• improvement of products commercial value in terms of greater confidence of customers and as a result increase of sales volume;


• improved quality of products;


• facilitates successful participation in tenders, competitions for organization’s product supply;


• clear alignment of organization’s business processes, efficient allocation of internal resources, responsibilities and authority of personnel within the existing management system.