On 20 November, at the international exhibition “Pharmtech & Ingredients”, held in Crocus Expo (Moscow, Russia), 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 The Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”) and PharmaPharm. The experts discussed new trends in digitalization, automation and quality assurance in pharmaceutical manufacturing.
Anna Plemyashova, the Corporate Strategy and Development Director of Beltel CJSC, shared her expert opinion on the benefits of big data and artificial intelligence:
“I see new opportunities in this field for the pharmaceutical industry particularly: first of all, shared service of equipment is a current trend. The successful process optimization systems are built using accumulated data.”
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 and listing 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.
Yuri Sandler, the Managing Director of PQE CIS, discussed data integrity in GxP-environments and spoke 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”:
“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 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.”
Vasily Vasiliev, the Head of Validation Group of R-Pharm, spoke about the experience of data integrity implementation and new technologies management in the example of pharma manufacturing:
“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.”
The speakers expressed their hope for a further data integration and that GMP regulatory requirements will be strictly followed.
Meanwhile, during the round table discussion, the partnership agreement between the integrated pharmaceutical portal “PharmaPharm” and “GMP News” web portal was signed.
Vyacheslav Fedorenko, the Chief Editor of ‘GMP News’, commented:
“We are signing this agreement to expand the information space. I am convinced that our cooperation will be long-lasting and fruitful.”