The 19th International Exhibition of equipment, raw materials and technologies for pharmaceutical production – Pharmtech & Ingredients 2016 – was held on November 22-25, 2016.
On the first day of the exhibition, Vladislav Nikolaevich Shestakov, Director of the Federal budgetary institution “State institute of drugs and good practices” of the Ministry for Industry & Trade, answered the questions of the industry-specific magazine “GMP News” and told about the inspectorate, the specific of inspecting сontract manufacturing and preparedness of the Russian pharmaceutical facilities for inspections conducted by RF Ministry for Industry & Trade.
This is not to say that the contract manufacturing differs from the conventional pharmaceutical production. Basically, by definition, if the production is declared, it must comply with the criteria and requirements of the country it is set up in. The difficulties of the contract production stem from the fact that sometimes more than three foreign companies (from three to seven) implement their manufacturing process at a single contract facility. And, we come across a situation where the manufacturing cycle is scattered. This definitely poses a certain challenge since I hardly recall any of such cases in the Russian pharmaceutical industry. It is mostly local and unobstructive in our context. However, we do not see any difficulties in this, we consider the whole chain, we should go through the entire technological process, review the entire quality system. Therefore, today the companies have two options, in other words, they may follow any of two approaches:
- First— each company manufacturing this or that pharmaceutical product at this contract facility shall apply itself and it definitely bears all the associated risks, it shall apply for this specific contract facility and undergo inspection. Thus, it turns out that if three or seven companies are engaged in the process at the facility, each of these companies individually shall apply for this facility. On the one hand, for us being the inspectorate such situation is not quite comfortable, since we, from time to time, move out (have to move out) three or seven times the same facility in order to inspect each product.
- Second (and from my perspective – the most reasonable one) – if the contract facility would have applied itself for inspection to the Ministry for Industry & Trade and would have stand as the initiator itself and would have indicated all pharmaceutical products. It is a different matter that there is a certain risk, as noted by our colleagues-drug manufacturers: what if the facility complies with the requirements for all of the products, but for a single one – not. We found the solution on the matter at hand: the facility might simply withdraw this product from the general list; then the whole portfolio of the claimed products will be assessed. It is another thing when the facility itself fails to comply with the standards, problems with the quality assurance system, human resources, manufacturing equipment that is deployed on it, spaces. In this case, there is nothing to say: all the products would fail to undergo the inspection.
In this respect, I think it is critical for the companies themselves to decide on the approach: whether they apply themselves or whether they apply cooperatively but at the same, then the inspectorate will schedule its activities since pursuant to the law, the timing allowed is 160 days and we have to meet this timeframe. According to different evaluations, to date we have met the deadline of 60-80 days, that is, we are fairly ahead of the schedule and thus, when one company applies first and the other company applies in a two-three months’ period, it appears to be a time gap that cannot be bridged and this will undoubtedly result in a situation when the inspectorate repeatedly attends the same facility.
According to Vladislav Shestakov, the Russian inspectorate continues to replenish its staffing. Currently there are approximately 38 inspectors on a full-time basis, more than half of them are trained and certified according to the international requirements imposed by WHO. And the development continues on.
One of the questions posed by the journalists to the Director of the Institute of good practices” referred to the preparedness and responsibility of the Russian facilities to receive the inspectors.
Those modern enterprises that are opened now, they initially set all standards, it may well be said, ahead of time, since they seek to develop export opportunities. One needs to rely not only on the domestic market but also to set the ambitious goals. Thus, there are no questions to companies of such kind. There are companies with a long-standing history, for several decades in operation, and they were established upon other standards that were in effect at that time. Now they pass through the phase of cardinal reconstruction and technological retrofitting. However, the most important thing in GMP is to ensure that the mentality of people, production standards change too. Therefore, now we are talking about the development of the national human capacities, staff training, it is necessary to generate industry-specific targeted programs; that is what our educational center is doing now.
I would like to reiterate that those companies that are unwilling to transit to a new standard, they would not have a change “to lie low”. And, if they fail to take any active steps, their future fate is very deplorable. Therefore, both shareholders and executive officers, in particular, need to be actively involved in tacking this issue since there is not much time left.
According to Vladislav Shestakov, the quality level of the modern Russian pharmaceutical enterprises are on par with the foreign facilities of the similar production.