The construction, commissioning and hand-over of pharmaceutical manufacturing buildings have become increasingly controlled by the requirements of regulatory agencies. Legislation requires that the process of validation is undertaken to establish that the facility is constructed in-line with the principles of pharmaceutical Good Manufacturing Practice (GMP). The validation process acts to ensure that the construction and building services systems are designed, installed and operate as intended and do not affect the quality of the manufactured product. A central objective of this thesis is to examine the sequential validation process and influencing factors that contribute to the facility attaining agency approval. A comprehensive review of the available literature indicates that projects regularly fail to meet their regulatory objectives due to the building provider and client's differing understanding and views of the validation process and of GMP. From this literature a validation model is derived and proposes that the design, installation and operation stages of the validation activity are time-series dependant sub-processes controlled through sensing, feedback and comparison. The research was largely qualitative, case-study based and used an interpretivist approach to analysis, which relied on participant observation and grounded theory techniques. Additional, external validation of the model was sought by collecting and analysing empirical data from an industry questionnaire The results of the study demonstrate that significant deviations between the model and the data exist and measures to construct compliant pharmaceutical buildings are often underdeveloped and result in unsuccessful project outcomes. The criteria by which the success of any construction project is judged are normally time, cost and quality. Time and cost are readily measurable, but the meaning of quality, in relation to the validation activity, can be more elusive and this is at the root of the problem of successful validation of pharmaceutical buildings.
|Publication status||Accepted/In press - 31 Jul 2006|