title: The strategic relevance of manufacturing technology: An overall quality concept to promote innovation preventing drug shortage.
abstract: Manufacturing is the bridge between research and patient: without product, there is no clinical outcome. Shortage has a variety of causes, in this paper we analyse only causes related to manufacturing technology and we use shortage as a paradigm highliting the relevance of Pharmaceutical Technology. Product and process complexity and capacity issues are the main challenge for the Pharmaceutical Industry Supply chain. Manufacturing Technology should be acknowledged as a R&D step and as a very important matter during University degree in Pharmacy and related disciplines, promoting collaboration between Academia and Industry, measured during HTA step and rewarded in terms of price and reimbursement. The above elements are not yet properly recognised, and manufacturing technology is taken in to consideration only when a shortage is in place. In a previous work, Panzitta et al. proposed to perform a full technology assessment at the Health Technological Assessment stage, evaluating three main technical aspects of a medicine: manufacturing process, physicochemical properties, and formulation characteristics. In this paper, we develop the concept of manufacturing appraisal, providing a technical overview of upcoming challenges, a risk based approach and an economic picture of shortage costs. We develop also an overall quality concept, not limited to GMP factors but broaden to all elements leading to a robust supply and promoting technical innovation.
authors.affiliation: Department of Pharmaceutical Sciences Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy; AFI, Study Group on Pharmaceutical Economy, Viale Ranzoni 1 20041 Milano, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Panzitta
authors.affiliation: AFI, Study Group on Pharmaceutical Economy, Viale Ranzoni 1 20041 Milano, Italy; Sanofi-Genzyme, Viale Luigi Bodio 37/b, 20158 Milano, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Ponti
authors.affiliation: AFI-Associazione Farmaceutici dell'Industria, viale Ranzoni 1, 20041 Milano, Italy; Recipharm AB, Via Filippo Serpero, 2, Masate (MI), Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Bruno
authors.affiliation: AFI, Study Group on Pharmaceutical Economy, Viale Ranzoni 1 20041 Milano, Italy; Chiesi Via San Leonardo, 96A, 43122 Parma, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Cois
authors.affiliation: AFI, Study Group on Pharmaceutical Economy, Viale Ranzoni 1 20041 Milano, Italy; Perugia Hospital, Pharmacy Department, 06132 Sant'Andrea delle Fratte, Perugia, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: D'Arpino
authors.affiliation: AFI-Associazione Farmaceutici dell'Industria, viale Ranzoni 1, 20041 Milano, Italy; School of Hospital Pharmacy, Pharmaceutical Sciences Department, Università degli Studi di Milano, Via Festa del Perdono 7 - Milano, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Minghetti
authors.affiliation: School of Hospital Pharmacy, Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy.
authors.forename: Francesca Romana
authors.initials: FR
authors.lastname: Mendicino
authors.affiliation: Department of Pharmaceutical Sciences Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy.
authors.forename: Luana
authors.initials: L
authors.lastname: Perioli
authors.affiliation: Department of Pharmaceutical Sciences Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy; AFI, Study Group on Pharmaceutical Economy, Viale Ranzoni 1 20041 Milano, Italy; School of Hospital Pharmacy, Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy. Electronic address: maurizio.ricci@unipg.it.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Ricci
mesh_terms: D003299:Cooperative Behavior; D004345:Drug Industry / Q000191:economics / Q000458:organization & administration* / Q000592:standards; D006801:Humans; D004364:Pharmaceutical Preparations / Q000191:economics / Q000600:supply & distribution*; D012106:Research / Q000458:organization & administration; D013673:Technology Assessment, Biomedical / Q000379:methods; D013678:Technology, Pharmaceutical / Q000458:organization & administration* / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations
keywords: Formulation; GMP; HTA; Manufacturing process; Manufacturing technology; Pharmaceutical technology; Quality; Shortage