Good Manufacturing Practices (GMPs) and process validation in the pharmaceutical industry : an in depth analysis
KeywordsPharmaceutical Industry ; GMPs ; Good Manufacturing Practices ; EMA ; Guidelines ; Process validation
One of the most important pillars of our modern society is the healthcare system, an integral part of which is the pharmaceutical manufacturing industry. This sector has grown to be one of the most complex, internationalized, and value adding. This dissertation begins by covering the reasons for choosing this subject and continuous by further justifying this through a thorough industry analysis. It then moves forward to study the history of Good Manufacturing Practices and how they became a necessity to ensure pharmaceutical product quality in today’s multipolar world. All major regulatory frameworks are relayed (International Conference on Harmonization, E.M.A., F.D.A., W.H.O., U.K., China, Pharmacopeias, I.S.O., P.I.C./S) and their key similarities and differences are discussed. The European regulatory framework is chosen for further examination, and this is provided through a chapter-by-chapter analysis of the guidelines for industry, drawn up by the European Medicines Agency. In addition, a list of every supplementary annex is given. Closing, the thesis examines the subject of validation and its importance as a tool for keeping production under a state of control and establishing proof of repeatability and quality. Finally, different types of validation are examined, focusing on the steps followed, their requirements and the necessary documentation.