The State Institute for Drugs and Good Practices (SID&GP), a federal budget-funded institution, and PQE Group are working together on elaborating an industry data integrity guidance.
The guidance will be prepared in order to develop the requirements for good manufacturing practices (GMP) with regard to the manufacturing of pharmaceutical substances and medicinal products.
Today, data integrity provides the basis for pharmaceutical quality systems ensuring the required quality of medicinal products. It is expected that the industry data integrity guidance will help manufacturers to create and use fully documented and validated information systems for acceptable control based on data integrity risks.
Data integrity requirements are equally applied to manually entered (paper-based) and electronic data. Manufacturers and analytical laboratories should be aware that the transition from automated computerized systems to manual paper-based systems does not in itself eliminate the need for data integrity controls.
“Ensuring data integrity is a global trend and a necessity for the entire industry. The creation of a special guidance together with PQE Group will strengthen the positions of Russian manufacturing, and its active use will improve the quality of medicinal products,” said Vladislav Shestakov, Director of SID&GP.