TY - THES ID - 135977441 TI - Project oriented learning - Towards a new GMP training tool at Pfizer Puurs AU - Hermans, Tom AU - KU Leuven. Faculteit Farmaceutische Wetenschappen. Opleiding Master in de industriële farmacie (Leuven e.a.) PY - 2018 PB - Leuven KU Leuven. Faculteit Farmaceutische Wetenschappen DB - UniCat UR - https://www.unicat.be/uniCat?func=search&query=sysid:135977441 AB - During this research project, a closer look was taken at the GMP advanced training, part of the training program at Pfizer Puurs. The aim of this training course is for white collar staff to develop a deeper insight into good manufacturing practice (GMP). Compliance to GMP guidelines is of utmost importance in order to guarantee the manufacture of safe, efficacious and quality drug products. The GMP advanced training constitutes of a classroom training which is followed by a self-study phase and is terminated when the participants pass a test. During this self-study phase, the participants have to study one of the departmental folders, which comprise of relevant GMP guidelines from the Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Japanese pharmacopoeia. However, these folders appear outdated and are not practical to look up GMP guidelines. Therefore it was decided to update these folders to an electronic tool. In order for this tool to be relevant and user-friendly, inputs from different sources were used. First, a systematic literature review was performed in order to search for informative literature on selected, relevant topics. This literature review revealed some interesting information on GMP in general and on training for personnel in other GMP related instances. Moreover, some interesting literature on the development of supportive tools was found as well. Secondly, in order to select focus areas that would need to be highlighted in the tool, the databases of the FDA and EMA, as well as internal audit reports of the last two years were screened. The database screening revealed that GMP related documentation on data integrity and documentation practices would need to be highlighted in the new tool. The results of the screening of internal audit reports are confidential and are not displayed within this thesis. Then, in order to grasp the managers’ opinions on the current GMP training, GMP guidelines, audits, and for them to provide some inputs for the new tool, nine managers, responsible for varying departments at Pfizer Puurs were submitted to an exploratory questionnaire. This revealed that in general, the managers were satisfied with the current GMP training at Pfizer Puurs. They also indicated that the departmental folders are not up-to-date and impractical to look up GMP guidelines. Furthermore for the tool to be successful and helpful, they advised that it should contain an advanced search function and be relevant to Pfizer Puurs containing many practical examples. Finally, the content of the tool was determined after screening the available sources of the FDA, EMA, ICH, World Health Organisation (WHO), Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), and some national regulatory agencies (China, Japan, South-Korea, Turkey, Brazil and Russia) and an overlap analysis of the current departmental folders. This overlap analysis resulted in a reduction of complexity of the current departmental folders, which would also be included in the new tool. With these inputs, a potential concept for the tool was designed. The new tool should consist of three parts: one part containing general GMP requirements, the second part containing updated versions of the current departmental folders and the third part highlighting focus areas within the GMP guidelines. ER -