SID & GP is setting sights on GEP?

Making a speech at the workshop in Minpromtorg of Russia, the Director of SID & GP Mr. Vladislav Shestakov talked about the Institute’s intention to get engaged in attestation of engineering solutions and announced launching of the activities on establishment of a dedicated design subdivision within the Institute. What will this design subdivision be? And will the pharmaceutical industry very soon face the transition to mandatory standards of good engineering practices?

The reasonability and the necessity of setting to rights the issue of pharmaceutical manufacture compliance with the requirements of good practices on the steps of design, construction and reconstruction were discussed back in November, 2018. Then, the Expert Board under the RF Ministry of Industry and Trade on Pharmaceutical Industry Development chaired by the First Deputy Minister of Industry and Trade Mr. Sergey Tsyb was set a task to develop the field of giving consultations on the topics of compliance with the requirements of good practices. This assumes assistance to pharmaceutical companies in expert evaluation of design documentation and implementation of the activities on supporting the projects of construction and reconstruction of manufacturing and laboratory facilities, as well as assessment of the pharmaceutical development in part of drug manufacture and quality control aimed at mitigating the risks of design non-compliance with license requirements and the requirements of good practices.[1] The State Institute of Drugs and Good Practices which has been authorized by Minpromtorg of Russia for carrying-out GMP inspections since 2015 got engaged in resolving the task set.

As explained by the staff of the newly-established design subdivision of SID & GP, the issue of regulating the activity by numerous design companies and the level of designs for new facilities and the facilities to be reconstructed largely depend on the demands of pharmaceutical companies, as well as on the motivation and the level of competence of the professionals engaged in pharmaceutical engineering activities. 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. 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.

Why SID & GP in particular? And why does it need its own design subdivision?

First of all, the Institute concentrates a tremendous potential including the knowledge and the experience in pharmaceutical manufacturing technologies applied today globally, the knowledge and the experience in the field of elaboration and functioning of the pharmaceutical quality system, as well as in the field of design, construction and operation of engineering systems in pharmaceutical manufacture.

Secondly, it possesses the comprehensive understanding of regulatory requirements, which is of key importance upon resolving the tasks of implementation of the culture of compliance with good practices both by engineering companies and by customers – Russian drug manufacturers.

What is such assurance that SID & GP has these competences based on? Here, it’s worth turning to the history of implementation of GMP standards and culture in the Russian pharmaceutical industry. Before 2015, when Minpromtorg of Russia authorized the Institute to carry out inspections of foreign manufacturers of medicinal drugs, the main type of the Institute’s activity was development of drug products: blood substitutes, organotherapeutic products, gene engineering insulins, etc. So, the status of the regulator was assigned to the institution where the staff possessed real hands-on experience and had the firsthand knowledge of the challenges faced by any manufacturer. It was decided to translate this experience to engineering. Thus, a new team of highly-qualified engineers with the confirmed experience in design and support of construction of the objects recognized in the pharmaceutical industry has already started giving consultations to companies on the topics of compliance with the requirements of good practices and is getting ready to elaborating design documentation of all stages at various steps of pharmaceutical manufacture lifecycle, starting from scoping studies, including the development of the concept design, to the author’s supervision over construction in part of technological characteristics, clean media and HVAC as the key aspects of the design.

Will the Institute’s subdivision created be able to communicate to the owners of manufacturing facilities – design customers – all risks of implementing the so-called “optimization” changes that are against the standards of good practices, which will eventually result in expenses on rectification activities and increasing the risks for patients’ safety and product quality? This will be subjected to monitoring, and the engineering market will be again reviewed in six months or in a year with a special focus on this government agency.

As reported by the Head of the Engineering Practice Department of SID & GP Mr. Igor Falkovsky, the status of the government agency, where the design subdivision is being created, should not scare the industry away: «On the contrary, we have a chance to suggest to the market the most advanced technology solutions in compliance with Russian and European standards and regulations, with application of the best architectural and engineering solutions. We have managed to bring into the fold the professionals using the capabilities of the Autodesk Revit software allowing to create the single informational model of the building, including the architecture, building structures and engineering systems.»

So, will there be accreditation of engineering companies and when?

Indeed, the most intriguing question is still the idea of attestation of engineering companies voiced by Mr. Vladislav Shestakov. But, as explained by SID & GP, this is not meant today, though, if the industry requests, it may be considered.

At the same time, SID & GP believes that it is necessary to already think about the option of switching to mandatory DQ execution by an independent body. «Very often we face the situation when engineering companies ask SID & GP to evaluate their designs. A part of designs is of proper level, while the other part has numerous observations. One and the same company may present designs of quite different levels – here, what matters is the competence of the staff working on the design solution. This is why the most useful will not be simply attestation of the design company itself, which may gather the dream team with the aim to obtain the sacred certificate, but qualification of design solutions case by case,» Mr. Igor Falkovskiy explained.