Spectrophotometry and pharmaceutical PAT/RTRT: Practical challenges and regulatory landscape from development to product lifecycle

Abstract

European Pharmacopoeia includes dedicated chapters for Raman, NIR and Chemometrics, as well as there is a lot of Academia research on the matter. Despite that, the word innovation is often associated to such tools and there is a still slow implementation at industry. The paper is the outcome of the Associazione Farmaceutici dell'Industria (AFI) Study Group on Process Innovation and Product Lifecycle; the aim is to describe some case studies referring to practical approaches in pharmaceutical industry, in order to depict challenges and opportunities for the implementation of spectroscopic techniques. Case studies include: feasibility and pre-screening evaluations, chemometric model development approaches, way for the method maintenance during commercial manufacturing, challenges for implementation on existing equipment and on sterile processes. Case studies refer to oral solid products, liquid products and sterile Active Pharmaceutical Ingradient (API) manufacturing. There are already successful and robust spectroscopic applications in pharmaceutical industry and the technology is mature: this is the outcome of a strong applied research performed at pharmaceutical production departments. It is necessary to acknowledge efforts done by industry as Research for strengthening the cooperation with Academia, so that advantage of process innovation might reach the patients in a fastest way.

Keywords: Chemometrics; Manufacturing technology; PAT-RTRT; Process innovation; Product lifecycle; QbD.