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Assuring integrity

On 20 November, at the international Pharmtech exhibition traditionally held in Crocus Expo, the panel discussion on the topic «Data integrity management: key aspects» was organized.

The event was organized within the round table discussion on the topic «The era of digitalization and data integrity. The view of the industry» supported by FSI «SID & GP» and PharmaPharm. The moderator of the discussion was Anna Plesovskikh, a managing partner of PharmaPharm: «Today, we witness the beginning of a new era of digitalization which requires new challenges, new opinions, and new bold decisions.»

The experts discussed new trends in digitalization, automation and quality assurance in pharmaceutical manufacture.

The discussion was opened by highlighting the main trends in today’s digital economy. Anna Plemyashova, the Corporate Strategy and Development Director of Beltel CJSC, shared her expert opinion on the benefits of big data and artificial intelligence: «These data are our everything. They will help us to improve efficiency and raise revenues in future. We have new capacities which can be processed and read by these data. And as soon as we start accumulating these data, we can analyze them. I see new opportunities in this field for the pharmaceutical industry particularly: first of all, shared service of equipment is a current trend. Using accumulated data, the systems allowing for successful optimization of all processes are built.»

Konstantin Koshechkin, the Head of IT Administration of FSBI Scientific Centre for Expert Evaluation of Medicinal Products of the Russian Ministry of Health, talked about the electronic systems for drug registration file compilation as a tool for assuring data continuity. The discussion also covered software solutions for automation of registration file compilation, changes in requirements for this process in view of the transition to EAEU regulations, and the perspectives of the application of systems assuring data integrity in the course of regulatory procedures.

«Problem No. 1 in the pharmaceutical market is a very high price of new drugs development. Here, implementation of data integrity systems can be of great help. The regulatory field is changing: starting from 2020, we should follow the procedures of the Eurasian Economic Union, which is an incentive for all market players to switch to digitalization. The information is accumulated rapidly and uninterruptedly, and it shall be duly summarized, consolidated and renewed», said Konstantin Koshechkin.

The topic of data integrity in GxP-environments was discussed with Yuri Sandler, the Managing Director of PQE CIS. He talked about cloud solutions in the pharmaceutical industry: «The data integrity notion as is appeared about 5 years ago, and since then, the focus on it has been increasing. During inspections, this aspect within companies is verified, and about 40% observations are related to the data integrity topic. It will be rational to advise the pharmaceutical industry to built the quality system for all procedures.»

The topic was supported by Igor Falkovskiy, the Head of Good Engineering Practice Department of FSI «SID & GP» of Minpromtorg of Russia: «It is a known fact that the majority of data in the industry is paper-based. But even paper-based documents should comply with GMP requirements and have a unique identification number. It also necessary to trace that effective versions of paper-based documents are used. If a computerized system is used, it automatically takes many issues off the table. We see untimely signatures in documents, witness uncontrolled copies of documents at working places. I hope that sooner or later everyone will come to the use of electronic versions.»

Oksana Pryanichnikova, a representative of the EAEU International Society for Pharmaceutical Engineering, talked about the current documents, about the concept and benefits of the use of ISPE guidelines: «The data integrity guideline was elaborated by the experts of the pharmaceutical industry with a significant input from experienced regulators all over the world. This is highly valuable accumulated experience. Unfortunately, today, the guideline is in English only, but we are working on the text in Russian.»

To what extents is such implementation economically feasible? How expensive are the processes? These questions were answered by Tatiana Lebedeva, the Commercial Director of Gluvex, who talked about the practice of equipment installation and operation as well as about the peculiarities of process automation: «The process of digitalization is inevitable. The economics is the primary stumbling stone, but, according to our calculations, it is fully paid off by the absence of revalidation and necessity to purchase additional software packages».

The professional opinion was also expressed by Dmitry Polstyanov, the General Director of X-tech: «Data integrity should come from all certain equipment units. Digitalization is a global trend. And the main difficulty for the pharmaceutical industry is time spending on data registration because every production step must be manually recorded. We produce 30% of time and the rest 70% of time is spent on all other work not related to production, which is money wasted. By connecting all process chains, we are able to avoid a large number of production rooms, which is considerable saving on space and time.»

Vasily Vasiliev, the Head of Validation Group of R-Pharm, talked about the experience of data integrity implementation and new technologies management in the example of pharmaceutical manufacture, outlined the risks and the possibility of concurrent challenges arising.«We are in the beginning of our way, but implementation of data integrity is the global task. It is important to acknowledge that a system does not work in and of itself: only by a hybrid method and with paper and electronic documents combined.»

Provision of data integrity was presented as exemplified by the software Agilent OpenLAB CDS 2 by Yuri Belykh, the Product Specialist of Agilent Technologies LLC, Russia. He talked in detail about the security of electronic records, about the software supplied by the company and its peculiarities, and explained the functions of operators’ actions traceability and electronic signatures application.

Drawing a conclusion, the speakers expressed their hope that the data will be further integrated, that experts will be interested in cases, that GMP regulatory requirements will be strictly followed, that the complex approach will be applied in resolving the problems arising, that companies will control data integrity at their sites, and the start may be with small projects acculturating data integrity to all industry subject-matter experts.

Besides, within the round table discussion, the partnership agreement between the common pharmaceutical portal PharmaPharm and the Internet-portal GMP News was signed.

«We are signing this agreement to expand the information space. I am convinced that our cooperation will be long-lasting and fruitful», assured the Chief Editor of GMP News Vyacheslav Fedorenko.