Differences between GOST Russia 52249-2009 and GOST Russia 52249-2004

Russian standard GOST 52249-2009 is analogue of GMP EU (Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use) except for a few points.
GOST 52249-2009 was prepared by the Association of Engineers to control microcontaminants (ASINKOM).

This standard includes a number of rules and regulations for organization work, quality assurance and quality production control of drugs, also contains the basic requirements to the room, equipment, and much more.

In first time GMP EU regulations were adopted in 2004 (GOST 52249-2004), during which time the European GMP standard has changed:

- Added new requirements in the main text;
- Changes in Application 1.3, 7,13,19,20;
- Changed structure of standard (in GOST 52249-2004 contained in Application 18 "Guidelines for the production of active pharmaceutical ingredients, which corresponded to rules GMP EU for 2003 In the renewed version of the GMP EC requirements for the production of APS have been transferred from the application into the main part, which consists of two sections.

In the latest edition of rules GMP EU introduced the application 20 on risk analysis, which is the text of guidelines ICH Q9 "Risk Analysis for quality " (Quality Risk Mangement). The text contained vague and unsuitable for practical use. Therefore application in the text of new standard is not included, as indicated in the footnotes to the text of standard in italics. In the text of standard are omitted references to EU Directive, that contain the original rules of GMP EU.

GOST 52249-2009 very different from the version of GOST 2004, primarily due to the practical application. In the production of sterile pharmaceuticals must be updated to take into account the requirements of GOST. Changed requirements for clean rooms and areas that affect the classification and methods of control of cleanrooms and clean zones. In 2009, the requirements have been simplified to the concentration of particles. There was a clear distinction between the rules for certification of clean rooms and routine control.

Texts in several parts have been fully replaced.