Model research of integrated system in vaccines supply chain and development of tools for the assessment of their effective implementation in clinical practice

Vakcinacija se smatra jednom od najkorisnijih preventivnih intervencija, zbog sposobnosti da kroz ciljane aktivacije ljudskog imunog sistema indukuje zaštitu protiv infektivnih bolesti. Svake godine imunizacijom se spasavaju životi oko tri miliona dece. Ipak i dalje 2,5 miliona ljudi širom sveta svake godine umire od bolesti koje mogu biti sprečene upotrebom vakcina. Razlozi za ovakav mortalitet su najčešće: finansijski aspekt, nedostatak neophodne zdravstvene infrastrukture i / ili nedostatak objekata upravljanja u hladnom lancu snabdevanja. Farmaceutska / biotehnološka industrija ima jedinstveno važnu ulogu u razvoju novih prijemčivih vakcina za sprečavanje i lečenje bolesti, i poboljšavanja života pacijenata. Rukovođeni ovim principom osnovno usmeravanje proizvođača vakcina odnosi se na unapređenje proizvodnje, distribucije i troškovno efektivne primene. Proizvodnja treba da odgovori zahtevima legislative i standardima menadžmenta kvalitetom koji su zahtevi savremenog tržišta. U istraživanju su analzirani zahtevi legislative – Dobre proizvođačke prakse (eng. Good manufacture practice, GMP) i Dobre distributivne prakse (eng. Good distribution practice, GDP) i tržišta koje nameće sisteme upravljanja prema standardima- ISO 9001, ISO 14001, OHSAS 18001, ISO 27001 i ISO 17025, a koji se odnose na famaceutsku kompaniju. Korišćenjem sistemskog pristupa, razvijen je model integrisanog menadžment sistema (IMS) koji odgovara potrebama i tendencijama savremenog farmaceutskog poslovanja na svim tržištima i koji je prilagodljiv budućim zahtevima, i stoga omogućava šire korišćenje od strane proizvođača i distributera vakcina različitog nivoa sistema kvaliteta. Model je baziran na Deming-ovom ciklusu povratne veze, tzv. PDCA ciklusu. Razvijeni model „Sunce“ je prvi model koji integriše pet standarda sistema menadžmenta kvalitetom i zahteve dobrih praksi u proizvodnji i distribuciji vakcina. Takođe, ovo je jedini IMS model namenjen za korišćenje u farmaceutskoj kompaniji. Poverenje u bezbednost vakcina je od kritične važnosti za nacionalne strategije imunizacije i za globalno javno zdravlje. Za očuvanje kvaliteta vakcina jedan od najvećih rizika nosi distribucija vakcina...Vaccination is considered the one of the most useful prevention interventions due to its ability that through targeted activation of the human immune , induce protection against infectious diseases. Every year the immunization saves lives of about three million children. Nevertheless, 2,5 million people worldwide die each year from diseases that can be prevented by the use of vaccines. The most common reasons for this mortality are: the financial aspect, the lack of the necessary health infrastructure and / or lack of facilities management in the supply cold chain. Pharmaceutical / biotechnology industry has a unique role in the development of new receptive vaccines for the prevention and treatment of diseases, and improvment of the lives of patients. Guided by this principle, basic gudelines for vaccine manufacturers relate to the improvement of production, distribution and cost - effective implementation. Production should meet the requirements of legislation and standards of quality management which are the demands of the modern market. The study analyzed legislation requirements - Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP) and market imposed management systems standards: ISO 9001, ISO 14001, OHSAS 18001 ISO 27001 and ISO 17025, which relate to the pharmaceutical company. By using a systematic approach a model of integrated management system (IMS) is developed that meets the needs and tendencies of the modern pharmaceutical business in all markets and that is adaptable to future requirements, and thus allows wider use by producers and distributors of vaccines with different levels of quality systems. The model is based on Deming feedback loop, the so called PDCA cycle. The „Sun” model, is the first model that integrates five quality management system and the requirements of good practices in the production and distribution of vaccines. Also, this is the only IMS model intended for use in the pharmaceutical company. Confidence in the safety of vaccines is critical for both national immunization strategy and for global public health..