Browsing by Subject "pharmaceutical industry"
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(2021)The purpose of this systematic review is to investigate the usage of artificial intelligence in the pharmaceutical industry in the fields of pharmaceutical manufacturing, product development, and quality control. Today, developing and getting a new drug on the market is time-consuming, ineffective, and expensive. Artificial intelligence is seen as one possible solution to the problems of the pharmaceutical industry. From 734 articles 77 academic study articles were included. Included articles showed artificial neural networks to be the most used artificial intelligence method between 1991 and 2021. The search was conducted from three databases with the following inclusion criteria: studies using AI in either pharmaceutical manufacturing, product development or quality control, English as the language, and Western medicine-based pharmacy as a branch of science. This systematic literature review has three main limitations: the possibility of an important search word missing from the search algorithm, the selection of articles according to one person's assessment, and the possible narrow picture of the used artificial intelligence methods in the pharmaceutical industry, as pharmaceutical companies also research the subject. The use of artificial intelligence in product development has been studied the most, while its use in quality control has been studied the least. In the studies, tablets were a popular drug form, while biological drugs were underrepresented. In total, the number of studies published increased over three decades. However, most of the articles were published in 2020. Nearly half of the articles had some connection to a pharmaceutical company, indicating the interest of both the academy and pharmaceutical companies in the use of artificial intelligence in manufacturing, product development, and quality control. In the future, the efficacy of artificial intelligence, as well as its limitations as a method, should be investigated to conclude its potential to play a key role in reforming the pharmaceutical industry. The results of the study show that a wave of artificial intelligence has arrived in the pharmaceutical industry, however, its real benefits will only be seen with future research.
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(2019)If pharmaceutical quality system fails it causes a hazard to the patient’s health, but also to the manufacturer’s economy. For this reason, the manufacturer’s must make sure their products comply with the quality requirements placed by authorities. To ensure the compliance, the authorities perform inspections at the manufacturing sites. If the site does not comply with the quality requirements, the authority will take necessary measures. The goal of this study was to find what type of quality issues FDA and the authorities within EU have observed while inspecting manufacturing facilities, which of these issues are most common, in which countries the sites companies with issues have been located. The results were assessed from European pharmaceutical company’s point of view. The data for the study was collected from Eudra GMDP database and from FDA Warning letters sent by FDA headquarters from years 2015-2017. Qualitative analysis of content was chosen as the method of analysis. The collected data was classified into main classes and subclasses based on reoccurring topics. The classes were transferred in tables to compare how which of the classes were most common. Most often the facilities with quality issues were located in China and India. The authorities also perform a lot of quality inspections in these countries, but that alone doesn’t explain the large number of quality issues in these countries. The number of sites with quality issues per inspection was also high. Both the authorities of EU countries and FDA had mainly observed similar issues. Often quality issues were related to data integrity. Other common themes were quality management system, cleaning of equipment and facilities and analytical methods. There were also some differences in the observed issues. E.g. FDA had rarely observed issues related to personnel while EU authorities had observed such issues frequently. Quality issues which had led to measures by authorities were often related to larger problems with the quality management or to very basic quality actions. If company doesn’t have well-functioning quality organization, the quality system is often inadequate also in other ways. By comparing their own activities with the issues observed at other companies, it is easier for a company to improve their quality and avoid major quality issuer before they occur.
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(2021)The objective of this research has been to investigate the management of alerts of Medicines Verification Systems in Europe. Verification of medicines according to Falsified Medicines Directive (FMD) came into force 9.2.2019. There is no standardized tool or system for the management of alerts, every Medicines Verification Organisation and manufacturer have had to find their own ways to manage the alerts. The research has been performed as a theme survey via questionnaire that has been sent to Medicines Verification Organisations in 30 European countries. Information to the questions of the questionnaire has also been gathered from the Internet pages that are mainly maintained by the Medicines Verification Organisations. This kind of method triangulation has been used in order to improve the reliability of the research. Answering rate of the survey was 17 %. By including the information gathered by method triangulation the overall yield percent of information in this study was 45 %. The information received via the questionnaire did not contradict with the public information. As conclusion, marketing authorization holders have been registered as users of the National Medicines Verification Systems or they have signed a contract with Medicines Verification Organisations. Marketing authorization holders are paying the costs of the Medicines Verification Systems. Penalties of FMD non-compliance are in use in part of the European countries. In the beginning of the implementation of the Medicines Verification System there has been stabilization periods in use which have already ended in half of the European countries. National competent authority is informed about system alerts typically in case of suspected falsification. In half of the European countries there is a separate computerized alert management system in use. Marketing authorization holder usually has access to the system. In some of the countries it is possible to integrate the system to the own serialization system of the marketing authorization holder. In six European countries there has been set a specific time for the alert investigation of the marketing authorization holder. Based on the results of this research the alert management system that covers the whole Europe that European Medicines Verification Organization is planning would really be needed. One common computerized system and common rules would ease up the alert management of all the stakeholders of the medicines verification.
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(2021)Objectives To investigate distribution and causes of drug shortages in five selected countries with data from public shortage notification registers. Design Statistical retrospective analysis of national drug shortage registers Data Public shortage notification register data from the first nine months of 2020 in Finland, Sweden, Norway, Spain, and the United States, partly combined with national drug registers. Results Altogether 5132 shortage reports from Finland (n=1522), Sweden (n=890), Norway (n=800), Spain (n=814), and the United States (n=1106) published during the first nine months of 2020 were found in the study. More than half (54%) of the active ingredient level shortages (classified by ATC code) found occurred in only one country, and only 1% occurred in all five countries. On a country level, 19-41% of the shortages were found only in a given country. The distribution of shortages by ATC category and drug form was significantly different between countries, especially between the US and European countries. Injectables were found to have an especially high shortage risk in the US, much less so in European countries. On the other hand, some drug classes were in shortage almost exclusively in Europe but not in the US. Conclusions Although drug shortages are a growing global problem, drug shortages are rarely global, but typically occur only in some countries, while other countries have an uninterrupted supply of the same drug. Drug shortages should be seen not just as a problem of manufacturing disruptions, but as a question of equitable and effective distribution of drug supply on an international level. Price differences and other commercial issues could be factors behind variation of shortages found between countries.Considering the limited and probing nature of the study, further research of shortage register data is certainly warranted. International comparative register study is a meaningful and valid method for further understanding in this field.
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(2019)Pharmaceutical industry is supervised by several competent authorities. These authorities all over the world inspect manufacturers in order to make sure they comply with the Good Manufacturing Practice (GMP) guidelines and produce quality products. If non-compliance with the guidelines is detected, the authorities can revoke manufacturing licenses and deny access of the products. Recent trend in pharmaceutical industry is that the Active Pharmaceutical Ingredient (API) manufacturing is concentrated in few factories. If this kind of manufacturer is declared non-compliant and is therefore unable to supply an API, it can lead to drug shortages. This research aimed to find out what kind of quality problems occur in API manufacturing. Because of the concentration trend, it is important to understand what kind of problems the manufacturers do struggle with to prevent any risk for shortages. This research aimed also to determine how much the quality problems in API manufacturing can impact on drug shortages. Also, the number and location of these non-compliance cases were investigated. The chosen time frame was 2016-2018. Several databases were used as information sources in this research. These databases are maintained by the authorities in the U.S. and Europe and they contain information about the inspections and the GMP deficiencies they have found during these inspections. With the information collected from the databases, an inductive content analysis was conducted to determine the reasons for non-compliance with GMP in API manufacturing. Other information (e.g. locations, names of APIs) was also collected from the databases and analysed to answer the rest of the research questions. Results show that the biggest problem areas in API manufacturing were data integrity and analytical testing. Other problems relating to documentation occurred also. The amount of these cases was quite stable, and the relative proportion declined during the time period. Comparison between the list of APIs and drug shortage databases showed that even over 30% of the non-compliant APIs were later in shortage. The effect was greater in Finland than in the U.S. Therefore, it was concluded that the most significant GMP deficiencies in API manufacturing were poor data integrity and inappropriate analytical testing procedures. Secondly, the number of non-compliance cases in API manufacturing has not increased during this time, but these problems may have had an impact on drug availability problems.
Now showing items 1-5 of 5