Title Kontrola kakvoće čvrstih oralnih oblika lijeka prije puštanja serije na tržište
Author Sanja Matković
Mentor Biljana Nigović (mentor)
Committee member Biljana Nigović (predsjednik povjerenstva)
Committee member Ana Mornar Turk (član povjerenstva)
Committee member Maja Lusina Kregar (član povjerenstva)
Granter University of Zagreb Faculty of Pharmacy and Biochemistry (Department of pharmaceutical analysis) Zagreb
Defense date and country 2021-09-10, Croatia
Scientific / art field, discipline and subdiscipline BIOMEDICINE AND HEALTHCARE Pharmacy Pharmacy
Abstract Cilj istraživanja
Cilj ovog specijalističkog rada je dati širi uvid u zahtjeve, opseg i složenost postupaka redovite kontrole kakvoće gotovih proizvoda od strane proizvođača lijeka prije puštanja serije lijeka na tržište te uloge i odgovornosti odgovorne osobe za puštanje serije lijeka u promet. Kroz okvir aktualnih regulatornih smjernica, zakonske regulative i zahtjeva dobre proizvođačke prakse, cilj je prikazati što sve obuhvaća kontrola kakvoće lijeka kao pojam te kroz primjer čvrstih oralnih oblika (tableta i kapsula) prikazati koja se analitička ispitivanja na gotovim proizvodima najčešće provode te na koji način i u koju svrhu se sve dobiveni rezultati koriste kako bi se osigurala kvaliteta, sigurnost i učinkovitost lijeka.
Materijali i metode
Istraživanja u okviru specijalističkog rada teorijskog su karaktera. Pretraživanjem odgovarajuće stručne i znanstvene literature, regulatornih smjernica, zakona i pravilnika, prikupljeni su podaci o zahtjevima kontrole kakvoće čvrstih oralnih oblika kod proizvođača lijeka prije puštanja serije na tržište, odnosno u promet.
Okosnicu regulatornih zahtjeva čine smjernice dobre proizvođačke prakse (GMP prema engl. Good Manufacturing Practice), nacionalna legislativa Zakon o lijekovima i popratni pravilnici, Europska farmakopeja i ICH smjernice (ICH prema engl. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
Bibliografske baze podataka (primjerice PubMed, Science Direct, ResearchGate, Scopus, Web of Science) i drugi elektronički izvori pretraživani su s ciljem pronalaženja podataka o ispitivanju čvrstih oralnih oblika gotovih proizvoda. Najčešća analitička ispitivanja koja se provode na gotovim proizvodima prikazana su kroz kontrolu kakvoće čvrstih oralnih oblika (tableta i kapsula) u skladu s odobrenjem za stavljanje lijeka u promet i farmakopejskim zahtjevima.
Rezultati
Rezultati su prikazani kroz regulatorne zahtjeve i analitički aspekt kontrole kakvoće čvrstih oralnih oblika. Regulatorni aspekt prikazuje zahtjeve dobre proizvođačke prakse za kontrolu kakvoće kod proizvođača lijeka, kroz osnovne zahtjeve kao što su odgovarajući prostori, oprema, obučeno osoblje i odobreni postupci za uzorkovanje te ispitivanje gotovih proizvoda do završne ocjene serije. Ocjena završnih rezultata ispitivanja prikazana je kroz evaluaciju rezultata izvan granica specifikacije, trenda, atipičnih i neočekivanih rezultata te kontinuirano praćenje trenda rezultata kao parametara vrednovanja prilikom puštanja serije lijeka na tržište od strane odgovorne osobe i za kontinuiranu procesnu verifikaciju proizvoda.
Analitički dio opisuje parametre ispitivanja čvrstih oralnih oblika (tableta i kapsula) koje definira proizvođač te koje je podnositelj zahtjeva za odobrenjem obvezan priložiti uz dokumentaciju o lijeku koja se dostavlja u obliku Zajedničkog tehničkog dokumenta. Prikazani su najčešći parametri ispitivanja čvrstih oralnih oblika koji obuhvaćaju fizikalno-kemijska ispitivanja te određena mikrobiološka ispitivanja.
Zaključak
Kontrola kakvoće lijekova u farmaceutskoj industriji i proizvodnji lijekova, dio je farmaceutskog sustava kakvoće te kao nezavisni odjel iznimno važna za provedbu odgovarajućih ispitivanja i evaluaciju završnih analitičkih rezultata s ciljem osiguranja kakvoće, djelotvornosti i sigurnosti svake serije proizvedenog lijeka prije njezinog puštanja u promet te za kontinuirano praćenje kvalitete proizvoda.
Abstract (english) Objectives
Objective of this research is to provide a broader insight into the scope and complexity of procedures for regular quality control of finished products by drug manufacturers before placing a batch of the drug on the market, and the role and responsibilities of the qualified person for batch release. Through the framework of current regulatory guidelines, legislation and requirements of good manufacturing practice, the aim is to show what is included in the quality control of the drug as a concept and through the example of solid oral forms (tablets and capsules) to show which analytical tests are most commonly performed on finished products and for what purpose all the results obtained are used to ensure the quality, safety and efficacy of the medicinal product.
Materials and methods
Research is of a theoretical nature. By searching the relevant professional and scientific literature, regulatory guidelines, laws and regulations, data were collected on the quality control requirements of solid oral forms at the manufacturer of the medicinal product before batch is released to the market.
The framework of regulatory requirements is the Good Manufacturing Practice (GMP) guidelines, national legislation, the Law on Medicinal Products and accompanying regulations, the European Pharmacopoeia and the ICH guidelines (ICH according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use).
Bibliographic databases (e.g. PubMed, Science Direct, ResearchGate, Scopus, Web of Science) and other electronic sources were searched with the aim of finding data on testing solid oral forms of finished products. The most common analytical tests performed on finished products are presented through quality control of solid oral forms (tablets and capsules) in accordance with the marketing authorization.
Results
The results are presented through the regulatory requirements and the analytical aspect of quality control of solid oral dosage forms.
The regulatory aspect shows the requirements of good manufacturing practice for quality control at the drug manufacturer, through basic requirements such as appropriate premises, equipment, trained personnel and approved procedures for sampling and testing of finished products until the final batch evaluation. The evaluation of the final test results is presented through the roles and responsibilities of the qualified person for batch release, its evaluation of out-of-specification results, atypical and unexpected results and continuous monitoring of the trend of results as evaluation parameters.
The analytical part describes the test parameters of solid oral dosage forms (tablets and capsules) defined by the manufacturer and which the applicant is obliged to enclose with the medicinal product documentation submitted in the form of the Common Technical Document. The most common parameters of testing solid oral dosage forms are presented, which include physicochemical tests and certain microbiological tests.
Conclusion
Drug quality control in the pharmaceutical industry and drug production is part of the pharmaceutical quality system and as an independent department it is extremely important for conducting appropriate testing and evaluation of final analytical results to ensure the quality, efficacy and safety of each batch of manufactured drug before its release to the market and continuous quality monitoring.
Keywords
kontrola kakvoće
čvrsti oblici lijeka
kapsule
tablete
zakonska regulativa
Keywords (english)
quality control
solid oral forms
capsules
tablets
legislation
Language croatian
URN:NBN urn:nbn:hr:163:295581
Study programme Title: Drug development Study programme type: university Study level: postgraduate specialist Academic / professional title: sveučilišni magistar/sveučilišna magistra razvoja lijekova (sveučilišni magistar/sveučilišna magistra razvoja lijekova)
Type of resource Text
File origin Born digital
Access conditions Open access
Terms of use
Created on 2022-03-16 13:44:43