GMP non-compliance in pharmaceutical manufacturing : qualitative content analysis of most typical non-compliance issues in EU non-compliance statements and FDA Warning letters

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http://urn.fi/URN:NBN:fi:hulib-201907093181
Title: GMP non-compliance in pharmaceutical manufacturing : qualitative content analysis of most typical non-compliance issues in EU non-compliance statements and FDA Warning letters
Alternative title: GMP laatuongelmat lääkkeiden tuotannossa : kvalitatiivinen aineiston sisällönanalyysi tyypillisimmistä laatuongelmista EU non-compliance raporteissa ja FDA:n Warning lettereissä
Author: Häggman, Verner
Other contributor: Helsingin yliopisto, Farmasian tiedekunta, Farmasian tiedekunta
University of Helsinki, Faculty of Pharmacy, Faculty of Pharmacy
Helsingfors universitet, Farmaceutiska fakulteten, Farmaceutiska fakulteten
Publisher: Helsingfors universitet
Date: 2019
Language: eng
URI: http://urn.fi/URN:NBN:fi:hulib-201907093181
http://hdl.handle.net/10138/303857
Thesis level: master's thesis
Discipline: Teollisuusfarmasia
Industrial pharmacy
Industriell farmaci
Abstract: 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.
Subject: GMP inspections
pharmaceutical quality
pharmaceutical industry
quality issues
GMP-tarkastukset
farmaseuttinen laatu
lääketeollisuus
laatuongelmat


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