Implementation of a quality risk management approach to commissioning and qualification in the biopharmaceutical industry

Abstract

Inefficient, traditional C&Q practices and a more recent regulatory focus on the application of risk assessment to pharmaceutical processes, assessing impact on product quality and the protection of the patient, have led to a new approach to C&Q. Commissioning and qualification is an integral part of the Process Validation Lifecycle and, if not executed efficiently, can contribute to increased costs and schedule delays in delivering facilities that are fit for their intended use. The focus of this research is to map the current implementation of Quality Risk Management and risk-based C&Q, to assess the benefits of risk-based C&Q and to analyse the obstacles to its implementation in the biopharmaceuticals industry. The research methods adopted in this dissertation consists of an extensive literature review, a comprehensive review of recent conference proceedings and a set of focused interviews with five biopharmaceutical industry Subject Matter Experts with a range of experience in C&Q in the biopharmaceuticals industry. The findings from the research show that the implementation of risk-based C&Q is at an early stage in the industry, that up to now the industry has focused too firmly on risk assessment tools at the expense of Quality Management Systems and that the industry faces a challenge in implementing the requisite supporting practices and in making the organisational and operational changes necessary to successfully execute risk-based C&Q. This dissertation recommends that senior management need to take greater ownership of the Quality Risk Management programme and run it as a site-wide programme. Organisations need to become more proficient at a wider range of risk assessment tools and practices and it also recommends that companies adopting a risk-based approach need to upgrade their programmes in the supporting practices of Good Engineering Practice, Design Review and Change Management.