| Sažetak | Cilj istraživanja
Premda medicinski plinovi čine mali udio u ukupnom zdravstvu Republike Hrvatske, njihova upotreba je neophodna, a važnost neprocjenjiva. Kao i svaka druga farmaceutska industrija, tako i proizvođač medicinskih plinova posjeduje farmaceutski sustav kakvoće koji je temeljen na propisima kojima su strogo definirani postupci od proizvodnje pa sve do isporuke prema zdravstvenim ustanovama.
Cilj ovog rada je opisati glavne indikacije najčešće korištenih medicinskih plinova, način njihove proizvodnje te pakiranja. Također, cilj rada je i istaknuti osnovne zahtjeve dobre proizvođačke prakse koje proizvođač mora zadovoljiti s ciljem dobivanja proizvodne dozvole te osnovne prinicipe registracije lijekova i medicinskih proizvoda.
Materijali i metode
Literatura je pretraživana prema temi i predmetu istraživanja. Ciljana pretraga provedena je na bazama PubMed, Google pretraživaču, na stranicama Agencije za lijekove i medicinske proizvode, putem znanstvenih članaka te dostupnim dokumentima proizvođača.
U ovom se radu raspravlja o posebnostima proizvodnje i registracije medicinskih plinova te se metodama deskriptivne analize i kompilacije opisuju specifičnosti vezane uz medicinske plinove.
Rezultati
Iznesene su osnovne indikacije upotrebe medicinskih plinova te je ukratko opisana upotreba takvih plinova izvan zdravstvenog sustava. U osnovnim crtama objašnjeni su postupci proizvodnje tekućih plinova. Opisana je klasifikacija medicinskih plinova sukladno Direktivi 2001/83 te Direktivi za medicinske proizvode (MEDDEV), a približena je i razlika između
Kroz poglavlja: osoblje, prostori i oprema, dokumentacija, proizvodnja, kontrola kakvoće i transport prikazani su zahtjevi dobre proizvođačke prakse koje je proizvođač dužan zadovoljiti s ciljem pribavljanja proizvodne dozvole, ali i osiguranja da je gotov proizvod siguran i kvalitetan za kliničku primjenu. Kao važan segment vezan uz fizička svojstva plinova opisani su i zahtjevi za sigurnosno rukovanje. Također rad daje pregled osnovnih postupaka registracije lijekova i medicinskih proizvoda s ciljem dobivanja odobrenja za stavljanje u promet.
Zaključak
Medicinski plinovi su plinovi korišteni u zdravstvenom sustavu te kao takvi predstavljaju mali udio u ukupnom zdravstvu. Radi se o vrlo jednostavnim i dugo poznatim molekulama proizvedenim u postrojenjima koja na istom principu rade dulje od 100 godina. Premda su dugo vremena isporučivani u bolnice kao proizvodi bez posebnog statusa, razvojem farmaceutske regulative bivaju prepoznati te u konačnici i registrirani kao lijekovi i medicinski proizvodi. Upravo zbog statusa kojeg su dobili, plinska industrija je dobila status proizvođača lijeka i medicinskih proizvoda. Kroz godine rada nekada samo proizvođači tehničkih plinova, a danas proizvođači lijekova i medicinskih proizvoda ustrojili su snažne farmaceutske sustave kvalitete kojima reguliraju proizvodnju, provjeru kakvoće, puštanje u promet te u konačnici i distribuciju prema zdravstvenim ustanovama. |
| Sažetak (engleski) | Objectives
Although medical gases make a small share in the total healthcare in Republic of Croatia, their use is necessary and the importance is essential. Like any other pharmaceutical manufacturer, manufacturer of medical gases has an organized pharmaceutical quality system based on laws and regulations by which all processes from production to distribution to healthcare institutions are strictly defined.
The aim of this paper is to describe the main indications of the most commonly used medical gases, how they are produced and packaged. Also, the aim of the paper is to highlight the basic requirements of good manufacturing practice that the manufacturer is required to meet with the aim of obtaining a manufacturing licence and the basic principles of the registration of medicines and medical devices.
Materials and methods
Targeted literature search was done on PubMed, Google search engine, website of Croatian Agency of Medicinal Products and Medical Devices, articles in the research journals and available documents of manufacturers.
This paper discusses the specificities of the production and registration of medical gases and by methods of descriptive analyzes and compilations specificities associated with medical gases are described.
Results
Basic indications of the use of medical gases have been described and the use of these same gases outside the health system is also briefly described. In the basic lines, the processes of production of liquid gases are explained. The classification of medical gases according to the Directive 2001/83 and the Medical Devices Directive (MEDDEV) is also described, and the difference between the medicine and the medical device is approximated. Through the chapters: staff, premises and equipment, documentation, production, quality control and distribution, the requirements of good manufacturing practice that the manufacturer is required to meet with the aim of obtaining a production license are also presented, as well as ensuring that the finished product is safe and of high quality for use on patients. As an important segment related to the physical properties of gases, safety management requirements are also described. This paper also provides an overview of the basic procedures for registering medicines and medical devices with a view to obtaining a marketing authorization.
Conclusion
Medical gases are gases used in the health system and as such the represent a small share in overall health care. These are very simple and long-known molecules produced in plants that work on the same principle for more than 100 years. Although they have been delivered to hospitals for a long time as products without special status, the development of pharmaceutical regulation they are beeing recognized and ultimately registered as medicines and medical devices. Because of the status the received, the gas industry has gained the status of medicine and medical device producers. Throughout the years, only manufacturers of medicine and medical devices have established strong pharmaceutical quality systems by which they regulate production, quality control, release on the market and ultimately, distribution to health facilities. |
