The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Creation of an Industry Data Integrity Guide

The Federal State Institution “The State Institute of Drugs and Good Practices” together with the PQE group of companies are developing an industry data integrity guide. Guide will be prepared to develop the requirements of good manufacturing practice rules (GMP) for the production of API and FPP. The text of the Guidelines will be posted on the official website of the FSI “SID & GP” for wide familiarization and commenting in July this year. Publicly the document will be presented during the III All-Russian GMP-conference with international participation in Kazan within the official opening of the second day of the conference, August 28, 2018.

Ensuring the data integrity today is the basis of the pharmaceutical quality system, which ensures that the drugs have the required quality. It is expected that the development of an industry-wide guide on data integrity will help manufacturers create and use information systems that provide an acceptable state of control based on the risk of data integrity, fully documented and justified.
Data integrity requirements apply equally to manual (paper) and electronic data. Manufacturers and analytical laboratories should bear in mind that the transition from automated computerized systems to manual, paper-based systems does not by itself eliminate the need for data integrity control.
“Ensuring data integrity is the world trend and the need for the entire industry. Creation of a special guide together with PQE group of companies will strengthen the positions of Russian manufacturers, its active application will help to improve the quality of medicines”, commented Vladislav Shestakov, director of the FSI “SID & GP”.

REFERENCE

The PQE group of companies is a global provider of integrated solutions for quality assurance and compliance in the medical and biological industry, has 18 offices around the world from Japan to the US. Thanks to unrivaled global leadership in data integrity services, PQE collaborated with COFEPRIS in Mexico to update the data integrity part for local GMP (NOM 059) and to train inspectors from several regulatory bodies around the world on the subject of “Data Integrity”. PQE has recently started operations in Russia by opening a new office in Moscow and can already count on multiple projects in the CIS region concerning the validation of computerized systems, IT infrastructure qualification and data integrity assessment.