PQE and SID&GP, together for Data Integrity guidance

New GILS rules powered by PQE

PQE Group is proud to announce that the draft of the new Russian Guide for Industrial Data Integrity has been published on the website of GILS – Russian State Institute of Drugs and Good Practices.

After the collaboration with COFEPRIS, the Mexican Regulatory Authority, for the creation of the data integrity chapter of the NOM 059 (the GMP Rule in Mexico) PQE Group is now supporting GILS and THE MINISTRY OF INDUSTRY AND TRADE OF THE RUSSIAN FEDERATION in setting all the GMP Data Integrity Requirements.

PQE Group CEO Gilda D’Incerti will be present in the Kazan 3rd Russian GMP Conference from 27th to 29th of August where the new Guidance will be presented to all local industry and all interested stakeholders. Click here for the event accreditation.

The globalization of the supply chain of pharmaceutical products leads to a steady increase in the complexity of the process, when a product can pass through several intermediaries before it can reach a patient. Such an environment implies the probability of penetration into the supply chain of counterfeit, falsified, substandard or improperly manufactured medicines, as forgers constantly improve the process of manufacturing counterfeit products that look identical to the original; most counterfeit drugs have little or no therapeutic value, and can cause serious health problems, since active substances in counterfeits are often absent, their dosage is reduced, their content is distorted or extended beyond the expiry date.

To minimize the risks associated with such problems, many state regulatory and control bodies have established specific rules aimed at ensuring the authenticity of pharmaceutical products and, in most cases, tracking drug products throughout the chain of sales. In general, these rules provide for the duty of the owner of the registration certificate to introduce a set of computer systems for the registration, authentication, preservation and exchange of reliable reporting on commercial products before it is released to the market.