Quality of pharmaceuticals is the basis for efficient prevention and treatment of health problems, good health, thus it is a condition for high quality of life. A series of appropriate GxP practices has been developed in order to improve quality of medical care.
GxP (Good … Practice) is the globally recognized system for ensuring quality of pharmaceuticals. GxP system covers all stages of pharmaceuticals lifecycle, from pharmaceutical development to end customer, in particular:
- Preclinical (laboratory) research regulated by GLP rules (Good Laboratory Practice),
- Clinical testing regulated by GCP rules (Good Clinical Practice),
- Manufacture regulated by GMP rules (Good Manufacturing Practice),
- Storage regulated by GSP rules (Good Manufacturing Practice),
- Wholesale regulated by GDP rules (Good Distribution Practice),
- Retail regulated by GPP rules (Good Participatory Practice).
Russian Register provides services on certification for conformity to GLP, GCP and GMP practices which are evidence based medicine frameworks and intended to standardize quality of medical services for population.
GLP. Good laboratory practice
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.
The RF national equivalent of GLP is the standard GOST R Р 53434-2009 “Good laboratory practice principles”, text of which is identical to GLP.
GСP. Good clinical practice
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.
Why Russian Register?
Application to Russian Register will allow you obtain:
- Confirmation of quality management system conformity for pharmaceutical manufacturers by the lead certification body of Russia,
- Possibility to undergo certification of an integrated management system for conformity to the requirements of 2 and more standards,
- Possibility to reduce cost of the service by involvement of qualified Russian-speaking auditors,
- Possibility to get a complex service on certification of management systems, products, personnel,Wide range of courses and seminars