This investigation attempts to examine the influences of validation on pharmaceutical processes especially at a new manufacturing facility that has to meet international requirements, and fulfil a cost effective business strategy. At Aspen Pharmacare, a pharmaceutical organisation, there are two manufacturing facilities situated adjacent to each other, one new and one old. The new facility creates ideal opportunities to supply products to local and international markets. The investigation compares legal requirements from local and international regulatory authorities. Validation and qualification practices as well as the problems encountered during the different phases are discussed. Particular attention is given to the validation approach at the new Aspen facility. Problems and proposed solutions relating to the design review, installation, operational, and performance qualification are discussed. Validation of analytical methods for cleaning analysis, cleaning validation of equipment, and optimisation of some tablet manufacturing processes are described. Statistical evaluations of analytical results are included to find the optimum conditions for integrating new personnel with new processes and equipment. A business model reviews the cost of non-conformances of the enalapril maleate 10 mg tablets manufactured at the two manufacturing facilities. Finally the dissertation proves that validation is not only a regulatory requirement but that it also provides benefits such as adding value to the business, and ultimately reducing the cost of medicines.

University of Macau / Institute of Chinese Medical Sciences