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.