Spectrophotometry and pharmaceutical PAT/RTRT: Practical challenges and regulatory landscape from development to product lifecycle
نویسندگان
چکیده
European Pharmacopoeia includes dedicated chapters for Raman, NIR and Chemometrics, as well there is a lot of Academia research on the matter. Despite that, word innovation often associated to such tools still slow implementation at industry. The paper outcome Associazione Farmaceutici dell’Industria (AFI) Study Group Process Innovation Product Lifecycle; aim describe some case studies referring practical approaches in pharmaceutical industry, order depict challenges opportunities spectroscopic techniques. Case include: feasibility pre-screening evaluations, chemometric model development approaches, way method maintenance during commercial manufacturing, existing equipment sterile processes. refer oral solid products, liquid products Active Pharmaceutical Ingradient (API) manufacturing. There are already successful robust applications industry technology mature: this strong applied performed production departments. It necessary acknowledge efforts done by Research strengthening cooperation with Academia, so that advantage process might reach patients fastest way.
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ژورنال
عنوان ژورنال: International Journal of Pharmaceutics
سال: 2021
ISSN: ['0378-5173', '1873-3476']
DOI: https://doi.org/10.1016/j.ijpharm.2021.120551