Good practices in drug quality assurance from development to the consumer

“In the last three years, Minpromtorg of Russia and SID & GP have built rather an effective mechanism of controlling GMP compliance,” this is how the work of the agencies was assessed by the Deputy General Director of STADA Mr. Ivan Glushkov who was forecasting reinforcement and establishment of new good practices in the country in a couple of years.

On 18 May, within the IX International Legal Forum in Saint Petersburg, the “Pharmaceutical industry” track at the “Drug circulation» session was the platform for industry-specific regulators and representatives of Russian pharmaceutical manufacturers to discuss the key trends in the field of good practices.

Traditionally, the first topic was related to GMP inspections. As emphasized by the Director of SID & GP Mr. Vladislav Shestakov, today, regulators and pharmaceutical companies are concerned by the issue of inspecting foreign API manufacturers. This is caused, among other things, by the recent recall of valsartan from the market preceded by the same of heparin.

“The reality has proved that the procedure of withdrawing the finished drug from circulation is not effective in terms of preventing presence of potentially hazardous drugs in the market. This is rather a mechanism of fighting against the consequences of a poor-quality drug circulation. While the preventive measures able to avert manufacture of drugs using APIs manufactured under the conditions not complying with Good Manufacturing Practice suggest mandatory inspecting of the manufacturing sites for APIs imported to the Russian Federation territory and being components of the drugs filed for approval. We are ready to discuss such a necessity with regulators, experts, and industry representatives,” Mr. Vladislav Shestakov said.

The next topic of drug quality assurance from development to the consumer in the context of good practices which is increasingly discussed among pharmaceutical professionals is related to pre-clinical trials.

“Although GLP principles were established by the relevant national standard GOST in 2010[1], the efforts in the field of pre-clinical trials in our country still have to go a long way and create a detailed regulatory framework able to control the quality and welfare of laboratory animals securing implementation of and compliance with the three-R principles (Refinement, Reduction, Replacement) by all laboratory institutions executing animal tests,” the Director of SID & GD is assured. “The reason is that, in case of drug export and market launching by the Russian companies in foreign countries, regulators very frequently ask for execution of additional pre-clinical trials locally, as they do not trust the results of Russian studies.”

Clearly, the topic of Good Engineering Practice was not left aside. During the last 2-3 years, the market of engineering has demonstrated, on the one hand, fantastic growth of service companies which from construction of residential complexes have switched to construction of pharmaceutical facilities with peculiar requirements for cleanliness grades, sterility and avoidance of product cross-contamination, and, on the other hand, well-known design companies focused on the pharmaceutical market and having a strong credit of trust among industry players, specializing just in construction of facilities and laboratory complexes manufacturing various types of dosage forms, have abandoned their business or found themselves on the edge. This situation has pushed pharmaceutical manufacturers to hire technical experts who have the necessary competences and have become available at the job market, at least for the period of construction and installation works. Moreover, as emphasized by drug manufacturers, they prefer to work not with the firms, but with the names, meaning persons the qualification of whom they can be confident in, regardless of the company they are working at the moment.

“Based on the results of many inspections and audits at pharmaceutical facilities carried out by the GMP inspectorate of SID & GP, as well as of the DQ activities in terms of design documentation, it is clear that, currently, all market players are challenged by the task of finding the best solution on aligning the needs of the plants which have initiated new construction or reconstruction with GMP requirements upon working out the design solutions,” Mr. Vladislav Shestakov said. “GMP requirements do not provide a designer with a clear answer to the question which design solution it is better to use in this or that case. So, it is high time to think about implementation of the culture of compliance with good practices in Russia. And as the industry asks our experts to introduce “smart regulation” of the market of engineering, we, inviting the interested stakeholders for cooperation, are working on the relevant solution. In particular, SID & GP is exploring the topic of introducing mandatory design qualification (DQ) for design companies operating in the pharmaceutical market. Engineering companies approach us with suggestions about mandatory accreditation of their activity, they even offer the criteria of such accreditation. We are analyzing the incoming offers and, taking into account the interests both of customers – plants and contractors – design companies, and, obviously, considering the need of patients in available, high-quality drugs, we will come out with an optimal solution in terms of the best world practices.

Answering the questions from the audience whether regulations and implementation of new good practices will become a “regulatory guillotine”, Mr. Vladislav Shestakov assured that, being an expert organization gaining more and more acknowledgement and trust among foreign colleagues every year and even month, SID & GP is aimed at making operations by pharmaceutical manufactures at the Russian market the most comfortable, as well as at supporting reduction of their expenses by increasing the level of reliance by foreign regulators in terms of the results of trials executed within the Russian Federation territory.