Yulia Victorovna Volovikova
Head of Design Bureau, Polisintez LLC
Summarizing the results of IV GEP-RUSSIA 2015 International Conference, in my opinion, speakers tackled the most important problems with which the majority of pharmaceutic companies meet when aiming to improve quality of products manufactured in accordance with both Russian requirements and recommendations and international ruling documents and standards.
Since manufacturers recognize the needs for increase in industrial management level, use and utilization of high performance equipment, process variables control and automation systems, personnel training the questions concerning methods of satisfying these needs frequently arise.
Critical decisions making often deals with contradictions between specialists of one and the same company. I thought that this Conference afforded an excellent opportunity to get acquainted with methods, solutions and opinions about any given problems and challenges expressed by management and top specialists of various companies.
I considered that hearing of divergent opinions and points of view, dicussions and constructive dialogues provided the possibility to elaborate an unified development model and reach clear understanding about criteria of processes estimation.
Thanks to my participation in the Conference, I was both creatively inspired by innovative approach submitted in the Conference report made by Mr. Aleksey Moiseev, ZETA LLC; I used to good the advantages and adopted the best practices suggested by Mr. Petr Shoturma, Zdenek Pavelek and some other speakers.
Head of Quality Assurance Department, TNK SILMA LLC
My participation in the Conference gave me a fair opportunity to acquire profound knowledge about GMP, in particular, about aspects relative to such intricate problems as GEP. All reports were made at a high level.
Reports named ‘Closed Systems‘ and ‘HVAC Systems – Case Studies‘ made by Mr. Rolf Jung impressed me greatly. His principles to design and operate ‘clean premises‘ could and should be used in practice in terms of rational economy.
In addition, Mr. Jakub Zhelizko made the meaningful report named ‘Premises with Controlled Temperatures and Humidity‘; the report itself represented not just grey theory pertaining to monitoring but real pharmaceutic enterprises case studies which were of great worth.
In general, it should be mentioned that the reports were made for persons with various levels of competence that, no doubt, indicated in-depth development of matters provided by hosts of the Conference since the Conference was attended both by persons with vast experince in pharmaceutic industry and persons-newcomers who only started their work, not easy but interesting.
HVAC and Water Plant Engineer Takeda Pharmaceuticals LLC in Yaroslavl
As it is known progress does not stand still and it means that we shall move forward together with it. Each of us does his/her best in order to improve personal skills step-by-step. Participation in GEP–RUSSIA Conference contributed to this improvement.
GEP–RUSSIA 2015 Conference was perfectly managed in such a way that its participants were able both to acquire information provided, communicate with each other and exchange views on points of interest.
I hope the Conference next year to be equally interesting. I wish all success!
Key Customer and Dealer Manager, Sartorius Stedim RUS LLC
Last year I participated in GEP Conference as an attendee. The problems highlighted in the course of Conference were topical. In 2015 Sartorius took part in that event as a partner and made the report named “Effective Application of Trial Filtration and Scaling of Filtration Processes in Biopharmaceutical Manufacturing”.
We were immensely impressed by work of the hosts of the Conference. Even at the Conference planning phase the every activity was well-timed and accurate. And colleagues‘ work at the Conference was efficient. It was fair to look at the coordinated team!
As far as reports were concerned, I liked the report made by Mr. Uri Bone best of all. The topic pertaining to water storage and distribution was perfectly developed, the spokesman’s charm captured the audience. And alternatively the report made by Chinese colleagues was obtuse due to its duration of fifty minutes and ample narrative tired the audience.
Sartorius mainly operates at the biotechnological market where issues concerning engineering practice is as actual as for “classical pharmaceutics” though have a set of peculiarities. Next year we hope to get to know more reports about special aspects of biopharmaceutical manufacturing concepts.
Anna Victorovna Basevich
Senior Lecturer in Industrial Engineering of Medical Products, State-Financed Educational Institution of the Higher Professional Education, Saint-Petersburg, Chemical & Pharmaceutic Academy of the RF, Candidate of Pharmaceutical Sciences
I would like to express gratitude to FAVEA for GEP-Russia 2014 Conference management. It should be mentioned that all reports were meaningful and topical. The reports pertaining to risk analysis at URS development and project implementation phases seemed most interesting to me. The Conference papers helped better understanding of quality system integration and GMP requirements for establishment of a pharmaceutic enterprise project. I hope that FAVEA will arrange the IVth GEP-RUSSIA International Conference in 2015.
Alexander Eugenievich Mikhailovsky
Chief Engineer, Takeda, Yaroslavl
Thanks for the perfectly managed Conference. I liked it very much. We obtained positive experience. All speakers made good reports and Zdenek Pavelek’s report should be specially mentioned. Reports were meaningful, slides were organized, outstanding and memorizing.
Special thanks for the evening reception!
We look forward to the next Conference.
We wish you luck at GEP and ISPE promotion in Russia and Ukraine!
Galina Alexandrovna Derbina
Chief Operations Officer, Sotex Pharmaceutical Company CJSC
I liked the report made by Mr. Zdenek Pavelek “Good Engineering Practice (GEP) – Basic Concepts and Principles”. The speaker read the report an hour and a half and I was all ears during that time since I understood that each idea was practically a guide to action. The detailed presentation may be used both as educational papers and training device for preparation of documents. At the end of his report Mr. Zdenek Pavelek said that further reports would explain and highlight the matter in detail; and it was really so. At the end of the day we managed to discuss the issue concerning e-learning system that was proposed by FAVEA. Mr. Zdenek Pavelek demonstrated the effectiveness and friendliness of the system integration and what issues it covered. He also showed how it might be used for control over level of personnel knowledge and understanding of GMP rules.
On the sidelines of the Conference I met with many colleagues, manufacturers and business partners with whom we have common interests or joint projects. Our communication was constructive and useful. There were no linguistic barriers though participants spoke Russian, English, Czech and Italian.
I also liked the Conference informal gathering arranged in the form of evening reception. Those who are capable of working know how to relax. I was very glad to meet young colleagues from Takeda, Yaroslavl, with whom we have partnership relations. Future belongs to young people!
Many thanks to the Conference hosts for innovative approach, well managed event and friendly environment under which the Conference was held.
Vladislav Nikolaevich Shestakov
Director, State Institute of Drugs and Good Practices Federal State Institution
It was interesting and useful for the State Institute of Drugs and Good Practices Federal State Institution management and personnel to participate in the Conference due to the possibility to raise issues concerning requirements to pharmaceutic enterprises engineering services work because such requirements are checked in the course of audits. On the one hand, it was very important that inspectors made clear those requirements and the audience expressly understood thereof, on the other hand.
Up-to-date requirements to Regulations pertaining to industrial management and drugs quality control in increasing frequency focus on management quality of all enterprise processes including quality of those processes which are the responsibility of engineering services. Presently, it is not sufficient, for example, to have simply protocols and reports on equipment and engineering systems qualification, but it is necessary that an enetrprise should demonstrate implementation of entire V-model of quaification works based on risk management.
One can hardly conceive of a management of engineering services routine operations without development and control over key performance indicators (KPIs) execution. Now GPM regulations are being updated and it is very important that management approaches should be in line with such updating. In this context, the Conference made a favorable opportunity to exchange experience between state organizations and pharmaceutic industry representatives.
Project Manager, Berhord A&D SRL
Our Company, BERHORD A&D, is busy with development and manufacturing of food and pharmaceutic industry equipment in Moldova. Stringent projects requirements fully cover the use of state-of-the art engineering experience doubtless accumulated by specialists of the international group of companies specializing in design and turn-key construction of pharmaceutic production and health care facilities. Observance of local limiting standards supplemented by GMP (Good Manufacturing Practice) international standards is a guarantee of high quality and product safety. Our Company specilists took part in III GEP-RUSSIA 2014 International Conference with great interest.
It was recognized that the Conference had the scenario elaborated in detail with well composed reports. General advanced level of reports based on practical matters provided the possibility to discuss and clarify wide range of topical issues brought up at drug production implementation phases. Good quality work of interpreters ensured authentic information perception by the Conference participants.
I would like to express my gratitude to the Conference hosts represented by FAVEA staff, Mr. Martin Grivnatsky, Ms.Alisa Melnikova, for excellently arranged event. It is evident that a man can do no more than he can, in other words, it was impossible to consider all issues arising in the course of work; so we hope such practice to be continued.
Eugeny Viktorovich Vlasov
Process Engineer, STADA PharmDevelopment LLC
The possibility to communicate with leading European specialists who made reports at the Conference was beneficial.
The events of such type become common.
In particular, interconnection model of design stages and project impmentation (known as “V-scheme”) arosed considerable interest.
The report concerning technologies developed and supplied for positron emission tomography centers was very informative. It was mentioned in “Project Evaluation” report that an error at the design phase was most critical thus proving the project quality priority.
In addition, I would like to mention that issues touched on in the reports are very important in terms of local manufacturing content both in connection with drugs and active product pharmaceuticals and pharmaceutical aids in various regions of the country.