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Orodispersible drug formulations are a current trend in the pharmaceutical industry, mostly intended for pediatric and geriatric patients. Oral lyophilizates are solid forms, intended either to be placed in the mouth or to be dispersed (or dissolved) in water before administration. The correct excipient composition is a prerequisite to provide lyophilizates with the appropriate visual appearance and disintegration time. Typically, they are composed of binders, such as gelatin and polyvinylpyrrolidone, fillers such as sucrose, mannitol, or sorbitol, taste modifiers, colorants, sweeteners, and preservatives. The main purpose of this study was to determine the optimal excipient scaffold to ensure the proper appearance of lyophilizates that have undergone aggressive drying conditions and a disintegration time of less than 3 min. In addition to mannitol and gelatin, the most frequently used binders, PVP K25, PVP K90, glycine, croscarmellose, and hydrolyzed gelatin were investigated. The results obtained revealed that lyophilizates with only mannitol and gelatin have a disintegration time that is too long, and that replacement of gelatin with PVP K25 led to friable and cracked lyophilizates. Considering disintegration time and visual appearance, lyophilizates with a mixture of gelatin, PVP K25, and mannitol (1:2:5) formed from liquid formulations with 6% (w/w) excipients were determined to be the most suitable. As a binder, PVP K25 expresses more appropriate characteristics relating to PVP K90. Addition of croscarmellose provided lyophilizates with a shorter disintegration time, whereas glycine only had a positive effect on the elegant appearance of lyophilizate cakes. Hydrolyzed gelatin was introduced with the aim of obtaining an even shorter disintegration time and at the same time an acceptable visual appearance of lyophilizates. This was achieved by lyophilization of solutions with 15% (w/w) of excipients with a hydrolyzed gelatin:PVP K25:glycine/croscarmellose:mannitol ratio of 4:2:0.5:4.5. Such lyophilizates show the highest potential for incorporation of poorly soluble and low-dose drugs.

Deep-learning-based approaches have proven to outperform other approaches in various computer vision tasks, making application-focused machine learning a promising area of research in automated visual inspection. In the dissertation, we apply deep learning to the challenging real-world problem domain of automated visual inspection of pharmaceutical products. We focus on investigating whether compact neural network architectures, adhering to performance, resource, and accuracy requirements, are suitable for application in the pharmaceutical visual inspection domain. We propose a compact and efficient convolutional neural network architecture design for the segmentation and scoring of surface defects, which we evaluate on a real-world dataset from the pharmaceutical product-inspection domain. In comparison with other related supervised segmentation approaches, we achieve state-of-the-art performance in terms of defect detection as well as real-time computational efficiency. When compared to the nearest best-performing architecture, we achieve state-of-the-art performance with a fraction of the parameter count, a multi-fold increase in inference speed, and increased surface defect detection performance. We furthermore propose an extension of the supervised approach to weakly-supervised learning via generated pseudo labels, which are obtained with an unsupervised deep learning model. The latter are utilized in a supervised fashion, since this allows the retention of compact model performance benefits, while removing or at the very least reducing the number of required manually annotated samples. Although this kind of approach is weaker when compared to supervised approaches using manually annotated labels, we achieve comparable results. Pristopi, ki temeljijo na globokem učenju, se izkažejo za učinkovitejše od klasičnih pristopov na različnih področjih računalniškega vida, zaradi česar je postalo aplikativno strojno učenje obetavno področje raziskav pri avtomatiziranem vizualnem pregledovanju. V disertaciji uporabimo globoko učenje za avtomatizirano pregledovanje površin na zahtevni problemski domeni farmacevtskih izdelkov. Osredotočimo se na vprašanje, ali so kompaktne arhitekture nevronskih mrež, ki ustrezajo zahtevam glede porabe virov ter detekcij anomalij, primerne za uporabo na področju vizualnega pregledovanja farmacevtskih izdelkov. Predlagamo kompaktno in učinkovito zasnovo arhitekture konvolucijske nevronske mreže za segmentacijo in napovedovanje pristonosti površinskih napak, katero ovrednotimo na zahtevni množici podatkov s področja pregledovanja farmacevtskih izdelkov. V primerjavi z drugimi sorodnimi pristopi nadzorovane segmentacije dosežemo najboljšo točnost pri detekciji napak ter računsko učinkovitost v realnem času. V primerjavi z najbližjo arhitekturo po točnosti, dosežemo boljšo zmogljivost z le nekaj odstotki števila parametrov, večkratno povečanje hitrosti napovedovanja, ter povečano točnost detekcije površinskih napak. Nadaljnjo predlagamo razširitev nadzorovanega pristopa v šibko nadzorovano učenje z uporabo psevdo label, pridobljenih z nenadzorovanim modelom globokega učenja. Slednje se uporabijo v nadzorovanem načinu, saj to omogoča ohranitev prednosti zmogljivega kompaktnega modela, hkrati pa odpravlja ali vsaj zmanjša potrebo po ročnem označevanju podatkov. Čeprav je tovrstni pristop šibkejši kakor nadzorovani pristopi z uporabo ročno označenih label, dosežemo primerljive rezultate.

The robustness of the pellet coating process with and without the use of an in-process coating thickness analyzer (PATVIS APA) was investigated. Pellets containing model drug were coated with a prolonged release film coating, using different process conditions. In the first set of experiments film coating was performed as process repetitions with unintentional variation of process parameters, and in the second set, controlled changes (inlet air humidity, gap between distribution plate and Wurster partition, starting pellet load) were made. Within the first set of experiments, the coating process endpoint was determined either via gravimetric consumption of coating dispersion or by means of in-line coating thickness monitoring. The release profiles of the pellets were analyzed and the density of coating calculated. Both methods of the process endpoint determination can be relatively robust in batch processing, if key factors influencing drug release profile are under control. PATVIS APA was shown to be a useful tool to better understand the coating process and can be helpful if coating process interruptions are encountered. Water content was shown to be the key factor influencing the drug profile, presumably by influencing the structure and thickness of the coating applied. Nasl. z nasl. zaslona. Opis vira z dne 25. 10. 2022. Bibliografija: str. 15-16. Abstract. ARRS, Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih

Binder jetting has the potential to revolutionize the way we produce medicine. However, tablets produced by binder jetting technology can be quite fragile and hard to handle. In this study, the printing process and ink composition were examined to optimize the mechanical properties of tablets. A model formulation containing the ketoprofen drug was developed and used as a base for optimization. Firstly, important printing parameters were identified with a fractional factorial design. Saturation and layer height critically influenced selected tablet properties. Relevant process parameters were optimized for tablet mechanical strength by using the D-optimization DoE approach. The best mechanical properties were achieved when saturation was set to 1 and layer height to 150 µm. On the other hand, binder ink composition did not appear to impact tablet mechanical strength as much as process parameters did. Three ethanol-water mixtures were tested at three tablet strength levels and no definitive conclusions could be drawn. The binder jetting process can be wasteful, especially if the unbound powder cannot be reused. To determine the suitability of powder blend recycling, the ketoprofen content was measured for 27 subsequent batches of tablets. While the trendline did indicate a slight reduction in ketoprofen content, the powder blend reuse can nevertheless be employed. Nasl. z nasl. zaslona. Opis vira z dne 30. 8. 2022. Bibliografija: str. 20-21. Abstract. ARRS

Razvoj novega zdravila v farmacevtski industriji je sestavljen iz različnih procesov, med katere uvrščamo tudi razvoj analiznih metod. Rezultati, ki jih dobimo z njihovo uporabo, nam omogočajo odločitev glede strategije za nadaljnji razvoj zdravila oziroma podajo informacijo, ali je zdravilo primerno za sprostitev na trg. Zato je bistveno, da so analizne metode natančne, točne in zanesljive. Ključna analizna metoda za analizo in sproščanje zdravil je tekočinska kromatografija visoke ločljivosti (HPLC), katere razvoj je zaradi kompleksne sestave vzorcev tekom razvoja lahko zelo zahteven. S tradicionalnim pristopom (>>one factor at a time<< ali OFAT) je proces razvoja in optimizacije metode HPLC dolgotrajen in nepregleden, hkrati pa z njim ni mogoče določiti morebitnih interakcij med parametri (faktorji), ki vplivajo na delovanje metode. Leta 2004 je Ameriška agencija za hrano in zdravila (FDA) prvič predstavila pristop razvoja z vgrajeno kakovostjo (QbD), katerega namen je izboljšati kakovost zdravil z njenim načrtovanjem neposredno v farmacevtski proces. Junija 2018 je ICH naznanila novo smernico ICH Q14, ki bo vključevala uporabo QbD za razvoj, optimizacijo in validacijo analiznih metod, imenovan pristop razvoja analiznih metod z vgrajeno kakovostjo (AQbD). V uvodnem poglavju smo v obliki preglednega znanstvenega članka predstavili teoretično ozadje uporabe AQbD in podrobno predstavili novejše primere, na katerih po korakih prikažemo metodologijo AQbD pristopa pri razvoju in optimizaciji metod HPLC. V prvem poglavju raziskovalnega dela smo se osredotočili na metodo HPLC iz Evropske farmakopeje (EP) za določitev sorodnih snovi v zdravilni učinkovini celekoksib. Ta metoda ne dosega v farmakopeji predpisanega kriterija testa ustreznosti kromatografskega sistema (TUKS): resolucija med celekoksibom in nečistoto B je bila neustrezna, resolucija med nečistoto A in celekoksibom pa mejna. Z uporabo načrtovanja eksperimentov (DoE) smo metodo optimizirali v območju farmakopejsko dovoljenih odstopanj. Z DoE smo ovrednotili štiri kritične parametre: delež metanola in acetonitrila v mobilni fazi, temperaturo kolone in pretok mobilne faze in določili optimalno območje delovanja metode (>>sweet spot<>central composite face design<< smo ovrednotili delež acetonitrila v mobilni fazi, temperaturo kolone in pretok mobilne faze, ter kot kritične odzive spremljali tri kritične resolucije in retencijski čas elucije zadnje nečistote. Z metodo večkratne linearne regresije (MLR) smo povezali vrednosti faktorjev z eksperimentalno določenimi vrednostmi odzivov v statistično pomemben matematični model z odličnimi napovednimi lastnostmi. Z uporabo metode Monte Carlo simulacij smo določili območje robustnosti metode (>>design space<>central composite face-centered design<< izvedli 17 eksperimentov. Z metodo MLR smo povezali vrednosti faktorjev z eksperimentalno določenimi vrednostmi odzivov v statistično pomemben matematični model z zelo dobrimi napovednimi lastnostmi. Z metodo Monte Carlo simulacij smo določili dve možni območji robustnosti metode (>>design space<

Uvod: Digitalno trženje omogoča zelo dobro razumevanje potrošniških potreb. Kljub dejstvu, da potrošniki vse več časa namenjajo uporabi spletnih družbenih omrežij, farmacevtska industrija sodeč po digitalni dozorelosti zaostaja za drugimi reguliranimi industrijskimi panogami, kot sta bančništvo in zavarovalništvo. Namen: Naš namen v tej nalogi je bil oblikovati priporočila o učinkovitem upravljanju javnih podob na spletnih družbenih omrežjih, oceniti doslednost in učinkovitost farmacevtskih podjetij pri izvajanju teh priporočil in določiti nabor tematik objavam, na katere so se potrošniki najpogosteje odzivali. Metode: Izvedli smo analizo računalniško posredovane razprave (348 objav) na spletnih dnevnikih Facebooka, Twitterja in LinkedIna, ter njihovih partnerskih podjetij Sprout social in Buffer med 31. 7. 2019 in 1. 2. 2020. Na podlagi teh objav smo izluščili priporočila o učinkovitem upravljanju javnih podob na spletnih družbenih omrežjih. Sledila je analiza računalniško posredovane razprave 10 farmacevtskih podjetij na javnih podobah Facebooka, Twitterja in LinkedIna. Podatke za analizo smo pridobili z neposrednim pregledom objav in javnih podob podjetij ter z uporabo programskih oprem Fanpage karma in Facebook performance quadrant report. Z uporabo programskih oprem QDA Miner Lite in Microsoft Excel smo izvedli kodiranje besedil in drugih oblik računalniško posredovane komunikacije. Rezultati: 25 priporočil o uspešnem upravljanju javnih podob na spletnih družbenih omrežjih smo oblikovali na podlagi rezultatov pregleda spletnih dnevnikov. Najpogosteje zabeležena priporočila smo uvrstili v kategorijo uporabe grafičnih elementov (42,2 %). Upravitelji javnih podob so najbolj dosledno izvajali priporočilo o dodajanju logotipov k videoposnetkom (83,2 %), najmanj dosledno pa priporočilo o uporabi zgodb (0 %). Določili smo povprečne stopnje angažiranosti sledilcev farmacevtskih javnih podob, ki so bile 0,056 % na Facebooku, 0,026 % na Twitterju in 0,051 % na LinkedInu. Obeleževanje praznikov in svetovnih dni je bila skupna tematika najbolj uspešnih objav farmacevtskih javnih podob. Zaključki: Farmacevtska podjetja ne izvajajo priporočil o učinkovitem upravljanju javnih podob na spletnih družbenih omrežjih dosledno. Stopnje angažiranosti sledilcev farmacevtskih javnih podob so še vedno podpovprečne v primerjavi z drugimi industrijami. Introduction: Digital marketing enables marketers to gain a better understanding of consumer needs. In terms of digital maturity, the pharmaceutical industry lags behind other regulated industries, such as banking and insurance, despite the fact that consumers spend more and more time on digital media. Aim: Our purpose was to generate recommendations for the successful management of online social network profiles, to evaluate the consistency and efficiency of pharmaceutical companies in implementing these recommendations and to identify common topics amongst posts with the highest engagement on pharmaceutical online social network profiles. Methodology: We carried out a computer-mediated discourse analysis (348 posts) on the blogs of Facebook, Twitter and LinkedIn including the blogs of their partner companies Sprout social and Buffer between 31. 7. 2019 and 1. 2. 2020. We generated recommendations on how to successfully manage an online social network profile based on the analysis. This was followed by a computer-mediated discourse analysis of 10 pharmaceutical company's profiles on Facebook, Twitter and LinkedIn. We obtained the data through a manual review of posts and profiles and with the use of the Fanpage karma and Facebook performance quadrant report software. Text and other forms of computer-mediated communication were encoded with the use of the QDA Miner Lite and Microsoft Excel software. Results: Based on the results of the blogs review we identified 25 recommendations on how to successfully manage an online social network profile. The category with the highest frequency of recommendations was the Graphic elements category (42,2 %). The most regularly implemented recommendation was the recommendation about adding logos to videos (83,2 %), while the least frequently implemented one was the recommendation about the usage of stories (0 %). We determined the average engagement rate on pharmaceutical online social network profiles which were 0.056% for Facebook, 0.026% for Twitter, and 0.051% for LinkedIn. Celebrating holidays and international days was the most common topic of the most successful posts on pharmaceutical online social network profiles. Conclusion: Pharmaceutical companies aren't implementing recommendations on effective management of online social network profiles consistently. The average engagement rate on pharmaceutical online social network profiles is still lower compared to other industries.

Zdravila za parenteralno rabo se vnesejo v človeško telo z injiciranjem in infundiranjem. Zaradi različnih lastnosti učinkovin parenteralni izdelki obstajajo v različnih oblikah: v praškasti obliki ali v raztopini. Vsi farmacevtski izdelki morajo ustrezati določenim standardom kakovosti, ki jih predpisujejo zdravstvene organizacije. Parenteralni izdelki morajo izpolnjevati še zahtevo po sterilnosti, saj so po definiciji namenjeni direktnemu vnosu v človeško telo mimo prebavnega sistema. Poleg zahteve po sterilnosti morajo parenteralni izdelki zadoščati še farmakopejskim zahtevam po odsotnosti vidnih delcev. Kontrola kakovosti parenteralnih izdelkov je rigorozna: vsak vsebnik je pred pakiranjem 100 %-no vizualno pregledan. Vsebniki z delci se med 100 %-no kontrolo izločijo. Z namenom sledenja pojavnosti delcev je potrebno vidne delce v izločenih vsebnikih tudi identificirati. Večinoma gre za delce, ki so tekom proizvodnega procesa v neposrednem stiku z izdelkom: npr. primarna embalaža, čepi, polnilne igle... Identifikacija poteka na več nivojih, končna stopnja pa je identifikacija na osnovi različnih spektroskopskih tehnik, med katerimi se najpogosteje uporabljajo: Ramanska spektroskopija, FTIR spektroskopija in LIBS spektroskopija. Identifikacija najpogosteje poteka preko primerjave spektrov delcev neznanih materialov s spektri referenčnih materialov, katerih vir je poznan. Za uspešno identifikacijo delcev na osnovi primerjav spektrov z referenčnimi spektri je ključnega pomena kvalitetna spektralna knjižnica. Magistrsko delo zajema postavitev spektralne knjižnice za namene identifikacije delcev z IR spektroskopijo v programskem okolju Spectrum 10 (Perkin Elmer). Vsaka knjižnica zahteva ustrezno ogrodje znotraj specifičnega programskega paketa, ki sem ga prilagodil potrebam Laboratorija za analizo delcev v družbi Lek d.d.. Najpomembnejši del je spektralna baza, ki vključuje spektre referenčnih materialov. Referenčni materiali so bili pridobljeni iz proizvodne enote, njihove infrardeče spektre pa sem posnel z različnimi tehnikami. Najpogosteje sem uporabil način snemanja spektra v ATR načinu z diamantnim kristalom. Materiale, ki so bili tanjši in bolj transparentni, sem posnel tudi v načinu transmisije. Na tak način sem metodi medsebojno primerjal, predvsem razlike v posnetih spektrih in ustreznost metode za določen material. Ugotovil sem, da način transmisije za debelejše vzorce odpove, zato sem se večinoma osredotočil na metodo ATR. Spektre sem knjižnici dodajal in testiral ustreznost njenega delovanja. Knjižnico je možno z novimi vnosi v prihodnosti nadgrajevati in predstavlja pomemben doprinos k identifikaciji delcev v Laboratoriju za analizo delcev družbe Lek. Parenteral pharmaceutical products are delivered into the human body by injection and infusion. Due to the different properties of the active pharmaceutical ingredients, parenteral products exist in different forms: either as a powder or a solution. All pharmaceutical products must meet certain quality standards prescribed by healthcare organizations. Parenteral products must also meet the requirement for sterility, as they are by definition intended for direct application into the human body past the digestive system. In addition to the requirement for sterility, parenteral products must meet the pharmacopoeial requirements for the absence of visible particles. Quality control of parenteral products is rigorous: each container is 100% visually inspected before packaging. Containers with particles are rejected during 100% control. In order to track the incidence of particles, visible particles found in the rejected containers need to be identified. These are mostly particles that are in direct contact with the product during the production process: e.g. primary packaging, stoppers, filling needles, etc. Identification is performed on several levels, and the final stage is identification based on various spectroscopic techniques, the most commonly used of which are Raman spectroscopy, FTIR spectroscopy and LIBS spectroscopy. Identification is usually performed by comparing the spectra of particles of unknown materials with those of the reference materials whose source is known. A successful spectral library is crucial for successful identification of particles based on spectra comparisons with reference spectra. The master's thesis covers the construction of a spectral library for the purpose of particle identification by IR spectroscopy in the software environment Spectrum 10 (Perkin Elmer). Each library requires an appropriate framework within a specific software package, which I have adapted to the needs of the Laboratory for Particle Analysis in the Lek company. Reference materials were obtained from the production unit and I recorded their infrared spectra using various techniques. Most often, I used the ATR mode with diamond crystal. The materials that were thinner and more transparent were also recorded in transmission mode. In this way, I compared the methods with each other, especially the differences in the recorded spectra and the appropriateness of the method to a particular material. I found that the transmission mode fails for thicker specimens, so I mostly focused on the ATR method. I added the spectra to the library and tested its suitability. The library can be upgraded with new entries in the future and represents an important contribution to the identification of particles in the Laboratory for Particle Analysis in Lek company.

Raziskovalno vprašanje (RV): Raziskovalno vprašanje članka je, kateri so osnovni elementi sistema kakovosti validacije računalniških sistemov, ki jih zahtevata evropska in ameriška zakonska ureditev farmacevtske industrije. Namen: Namen članka je prikazati oblikovanje sistema kakovosti za validacijo računalniških sistemov v farmacevtski industriji, ki bo skladen z evropskimi in ameriškimi zakonskimi zahtevami. Metoda: S pomočjo deskriptivne metode in metode komparacije prikažemo evropske in ameriške zakonske zahteve. S pomočjo metode klasifikacije ugotovimo osnovne elemente sistema kakovosti in jih na podlagi medsebojne primerjave evropske in ameriške zakonodaje z metodo kompilacije opredelimo. Rezultati: Opredelitev elementov v obliki splošnih in temeljnih postopkov, ki jih mora organizacija opredeliti in vpeljati za vzpostavitev sistema kakovosti. Za primer smo vzeli farmacevtsko industrijo, ker je le ta zaradi zagotavljanja varnosti uporabnikov zdravil podvržena strogim zakonskim zahtevam. Družba: V članku prikazan sistem je lahko osnova za vsa podjetja, v katerih imajo računalniški sistemi pomembno vlogo in je zato vzpostavitev sistema kakovosti za njihovo validacijo nujen pogoj ustreznega obvladovanja računalniških sistemov. Organizacija: Prikazan sistem je osnova za dejansko izvajanje posameznih validacij računalniških sistemov v konkretnem podjetju. Originalnost: V literaturi nismo zasledili opredelitev elementov sistema kakovosti za validacijo računalniških sistemov. Omejitve/nadaljnje raziskovanje: Glavna omejitev prikazanega sistema kakovosti je, da je oblikovan za farmacevtsko panogo, ki je zaradi svoje narave močno regulirana. Nadaljnje delo mora biti usmerjeno v testiranje primernosti oblikovanega sistema z njegovo uporabo na konkretnih primerih znotraj farmacevtske industrije in v analizo potrebnih prilagoditev/ poenostavitev oblikovanega sistema za manj regulirane dejavnosti.

Eden pomembnih izzivov, s katerimi se soočajo farmacevtska podjetja po svetu, je razpoložljivost proizvodnih sredstev. Zaradi specifičnosti farmacevtske industrije ter vrednot podjetja je bila razvita lastna metoda optimizacije proizvodnje. Lastna strategija je sestavljena iz treh faz. V prvi fazi je potrebno zbrati, analizirati in vrednotiti podatke o zastojih, na podlagi katerih lahko prepoznamo izgube, ki najbolj negativno vplivajo na razpoložljivost, ter le-te odpravimo. Druga faza se posveča skrbi za delovna sredstva in delovnemu okolju. Faza zajema metodo 5S ter potek dokumentiranja poti delovnega sredstva od prevzema do odpisa, s katero zagotavljamo skladnost s farmacevtskimi regulativami, boljšo sledljivost in zanesljivost. Tretja faza se osredotoča na izboljšanje razpoložljivosti delovnih sredstev z optimizacijo vzdrževalnega procesa v podjetju, s čimer odpravimo neplanirane okvare. Za potrebe učinkovitega vzdrževanja smo nadgradili sistem planiranja nadomestnih delov za celotno podjetje. Pri tej fazi sta bili razviti tudi lastni različici FMECA analize in analize kritičnosti. Kot osnovo za razvoj lastne metode uporabimo načela celovitega produktivnega vzdrževanja oziroma TPM, saj je najbolj kompatibilna z vrednotami in cilji podjetja. Z opisanimi metodami nam je uspelo povišati razpoložljivost manipulatorja iz 83,2 % na 94,1 %, znižati MTTR iz 2,4 na 1.4 h in ustaviti trend naraščanja vrednosti zaloge nadomestnih delov. One of the biggest challenges that the pharmaceutical industry is facing is the availability of production and logistical equipment. Due to the specificity of the pharmaceutical industry and the values of the company, a new method of production optimization was developed. Developed strategy consists of 3 phases. The goal of the first is to gather, analyze and evaluate data from machine stoppages, in order to recognize the most influential losses and remove them. The second phase focuses on machine asset care, by which we ensure compliance with pharmaceutical regulations, better traceability, and reliability. The third phase tries to improve the availability of the machines through the optimization of maintenance procedures, thus eliminating unplanned failures. For achieving an efficient maintenance strategy, we also upgraded spare part management system. In addition, we develop our own variants of FMECA analysis and HML criticality analysis. With those three steps, we achieved an increase of availability of pallet manipulator from 83,2 to 94 %, reduced MTTR factor from 2,4 to 1,4 h and stopped a rising trend of spare parts stock value.

Farmacevtska industrija je na eni strani močno odvisna od okolja, na drugi strani pa spada med njegove večje onesnaževalke. Onesnažuje ga od vhodnih surovin, uporabe raznovrstnih kemikalij, razvoja in kliničnih testiranj, spodbujanja prevelike porabe zdravil do ravnanja z odpadnimi zdravili in drugimi odpadki, ki nastanejo skozi celotni proces v farmacevtski industriji. In ker industrija skupaj z razvojem pomeni nenehno črpanje naravnih virov, je edini možni razvoj – trajnostni razvoj, ki poudarja gospodarsko rast s skladnim delovanjem na treh področjih: gospodarstvu, okolju in družbenem razvoju. Magistrsko delo v prvem delu predstavi začetke farmacevtske industrije v eni izmed slovenskih regij, definira tri vidike trajnostnega razvoja – gospodarski, družbeno-kulturni in okoljski vidik, podrobneje trajnostni razvoj in odpadke ter predstavi farmacevtsko podjetja X, ki se ukvarja s proizvodnjo generičnih zdravil. V delu je posebej predstavljena njihova okoljska politika in zaposleni, še posebej njihovo izobraževanje glede trajnostnega razvoja in odpadkov ter njihovo ravnanje z odpadki. Sledi empirična analiza anketnega vprašalnika, ki je bil izveden med zaposlenimi v proizvodnji podjetja X, primerjava lastnih ugotovitev z ugotovitvami iz letnega poročila podjetja o trajnostnem razvoju in glavne ugotovitve. V sklepu magistrskega dela so podani nekateri trajnostno usmerjeni ukrepi podjetju X za lažji prehod na zeleno oz. krožno gospodarstvo. Pharmaceutical industry is on the one side highly dependent on environment and on the other side, it is one of the major environmental pollutants. It pollutes it from input materials, the use of a variety of chemicals, development and clinical trials, the promotion of excessive consumption of medicines to the management of waste medicines and other wastes that arise throughout the entire process in the pharmaceutical industry. Because industry, together with development, means the continuous exploitation of natural resources, the only possible development is sustainable development, which emphasizes economic growth with coherent action in three areas: economy, environment and social development. At the introduction of the master's thesis we present the beginnings of the pharmaceutical industry in one of the Slovenian regions, define three aspects of sustainable development - economic, socio-cultural and environmental aspect, more precisely sustainable development and waste, and we present pharmaceutical company X, which deals with production of generic medicines. In thesis, we present their environmental policy and employees, in particular their education on sustainable development and waste, and their management of waste. Then follows the empirical analysis of the survey questionnaire, which was implemented among employees of the production in company X and a comparison of our own findings with findings from the company's annual report on sustainable development. In the conclusion of the thesis, some sustainably targeted measures are given to company X for easier transition to green, circular economy.

The pharmaceutical industry is one of the most competitive businesses in the world. Supply chain in this industry has been directed towards the production of large batches to avoid lack of supplies, and the achievement of regulatory requirements, at the cost of high level of inventory, higher costs and inventory write-off due to expiration or other reasons. In recent years this industry is facing major changes and challenges such as intense globalization processes, increased competition and innovations in technologies, which has broadened and deepened risks in supply chain. The paper reports the results of the study of the risk in distribution processes of Slovenian pharmaceutical companies, which was conducted among five companies and aims to draw attention to risks that arise in supply chain, to emphasize the importance of their management and to present a model for an effective assessment of risk in companies, developed at the Faculty of Logistics.