Russian Institute for Drugs and Good Practices unveils new data guide

The Moscow-based Russian institute has launched a new data integrity guide.

The Russian State Institute for Drugs and Good Practices (SID&GP) has partnered with the technology and compliance consultancy PQE Group to publish a new Guide for Industrial Data Integrity on the institute’s website.

The aim is to set out all the Good Manufacturing Practices (GMP) Data Integrity Requirements, in collaboration with the Russian Federation’s Ministry of Industry and Trade.

The consultancy’s Francesco Amorosi, Business Development Vice President, said the partnership reflected the changing market conditions and a growing trend towards internationalisation in the pharmaceutical sector. “The landscape in the sphere of regulation is changing and all companies involved in the production of drugs and medical products must adapt to these changes,” said Amorosi.

“For PQE, as a provider of global solutions, is possible to support these companies in their efforts to participate in this internationalisation process. I believe that this trend will be positive for us. For the same reason, we have opened many branches around the world, including in Russia, this year.”

The globalisation of the supply chain

The globalisation of the pharmaceutical supply chain was leading to a steady increase in the complexity of the process, when a product can pass through several intermediaries before it reached a patient, according to PQE. That was said to increase the potential for counterfeit, falsified, substandard or improperly manufactured medicines to penetrate the supply chain.

“To minimise 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,” said the consultancy. “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.”

The new Data Integrity Guidelines were revealed at the recent Third Annual GMP Conference in Kazan; about 715 kilometres east of Moscow. The event was organised by the Ministry of Industry and Trade of the Russian Federation and State Institute of Drugs and Good Practices.

‘Inspections of pharmaceutical enterprises’

The Director of the State Institute of Drugs and Good Practices, Vladislav Shestakov, said the organisation was one of the country’s leaders in the fields of research and development and in fostering pharmaceutical manufacturing. “This is why the Institute [known as GILS] was chosen as a specialised state institution for carrying out audits, and – further – inspections of pharmaceutical enterprises on compliance with Good Manufacturing Practices,” said Shestakov, in a statement on the company’s website.

The Institute aimed to assist in the implementation of the “good practices at pharmaceutical enterprises, thus contributing to the growth of fair competition in the industry and to the provision of safe high-quality drugs to people living in Russia”, he added.

PQE Group’s latest collaboration with Russia follows an earlier partnership with the Mexican Regulatory Authority, COFEPRIS, to create a data integrity chapter for the country’s Good Manufacturing Practices Rule, known as NOM 059.

Meanwhile, PQE us a ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle. The organisation operates offices in Europe and North and South America, the Middle East, India and China.