Lean Commissioning and Qualification Creates Cost Reduction Opportunities
Major changes in the regulatory environment over the past few years have created significant time to market cost reduction opportunities for pharma manufacturers.
Minimising time to market of new products and manufacturing facilities is a key consideration for all pharma companies. While previously this was heavily influenced by what many viewed as an inflexible and cumbersome regulatory environment, the past five years has seen a major change with increased harmonisation of standards and the adoption of a more flexible, process-led and end-user-focused approach to product and plant approval. At the same time, leading thinkers within the industry have responded with the development of a number of C&Q best practice standards such as the ASTM E2500-07 and the ICH Q8, Q9 and Q10, all of which have been approved by the various regulatory bodies and have helped to create an opening for pharma manufacturers everywhere to reduce costs and speed their time to market.
Underpinned by these new best practice standards, this process and end-user focus will mark the way forward for the pharma industry for the years ahead, with the early adopters as always gleaning the maximum benefit. Despite continuing uncertainty in the global marketplace with only India and China continuing to show strong growth, Singapore quiet and Europe and the US holding steady, the combination of a more engaging regulatory environment and innovative new C&Q standards means that the time is right for forward-thinking companies to invest in change. These new standards have helped to significantly streamline the overall project process by focusing on getting the critical aspects right first time every time. All processes are documented from the start to support the next phase of development which means much earlier and closer involvement of C&Q teams and typical time to market savings of five to six months on 30 month projects.
Leading ASTM Practitioner
With more than 16 years of C&Q experience, PM Group is recognised as one of the leading ASTM E2500-07 practitioners in both the European and Asian markets. We have customised the standard to meet specific client requirements on a number of projects since it was first introduced. Our combination of customisable ASTM, full risk assessment toolbox and lean C&Q expertise backed by our full project lifecycle capability means that we are uniquely positioned worldwide to provide a top quality, cost-effective, flexible and sustainable service for all our clients in the pharma sector.
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