A tool for modelling the impact of regulatory compliance activities on the biomanufacturing industry

Abstract

Quality control (QC)/quality assurance (QA) and batch documentation form key parts of the in-process validation procedure for any biopharmaceutical. The activities of QC/QA and batch documentation rather than the manufacturing steps themselves are usually rate limiting in a plant ( Ramsay, 2001 ). Thus, managing QC/QA and batch documentation becomes a challenge. This paper presents the configuration of a prototype tool for modelling the impact of in-process testing and batch documentation in the biopharmaceutical-manufacturing environment. A hierarchical task-oriented approach was employed to convey maximum user flexibility. The impact of employing a range of manufacturing options on financial and technical performance was used in a case study to evaluate the functionalities of the tool. The study aims to investigate the effect of regulatory compliance activities on operational costs and demands on resources. The study demonstrates the use of such a software tool for the facilitation of early planning of process development and the appropriate allocation of resources to each stage of manufacturing including in-process testing and documentation. The modelling tool provides realistic indications as to the feasibility of different manufacturing options and ultimately is an aid in the decision-making process.