Procurement of capital projects and Good Manufacturing Practice in the pharmaceutical industry

By Matthew Needham-Laing, Head of Construction & Engineering, Stevens & Bolton LLP

Pharmaceutical companies are required to implement modern quality systems and risk management approaches to ensure that a procedure, process or activity maintains the necessary level of compliance at all stages to meet the requirements of the Food and Drug Administration, the World Health Organization, the European Commission and the national agencies responsible for the regulation of the pharmaceutical industry within their jurisdictions.

Those agencies produce regulations for Good Manufacturing Practice (GMP) and guides to achieving quality management. The GMP regulations and guides produced by those agencies include within their scope the facilities in which the pharmaceutical products are tested and manufactured, therefore the design and construction of those facilities should be evaluated and following completion, validated in the same way as any other process within the pharmaceutical industry. As a lawyer involved in dispute resolution, in my experience it is during the design and construction of those pharmaceutical facilities that the quality management processes of the pharmaceutical industry clash with the processes of the construction and engineering industry, sometimes with unfortunate results.