Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

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4 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Process Development T he AFI (Industrial Pharmacist Association) is an Ital- ian professional association aiming to promote cultural initiatives and practical/professional updating for its members within the pharmaceutical industry. This ar- ticle contains a set of indications elaborated by the AFI working group on process validation (PV) according to current thinking and indications given in guidelines issued by regulatory authorities both in Europe and the United States. The new approaches for PV suggest a roadmap from process de- sign up to the validation and maintenance of the state of control. According to these concepts, drug product quality is generated start- ing from the initial development phases, is defined in the manufac- turing process intended to be validated, and continues throughout the lifecycle according to quality-by-design (QbD) and quality risk management (QRM) principles. This article illustrates the concepts, the approaches, and the tools available to implement this modern vision of PV for pharmaceutical products, specifically in reference to sterile dosage forms (in particular liquid and freeze-dried products). Freeze-dried and liquid products were selected as they are receiv- ing greater attention in view of the increasing number of biological and biotechnological products. And yet, despite the progress made on lyophilization technology, there are still several lyophilization cycles not designed/optimized according to science (e.g., product temperature in primary drying overcomes collapse temperature, the Francesca Speroni is project leader at PTM Consulting; Ilaria Franceschini is in Pharmaceutical Technology at Italfarmaco; Maurizio Valleri is in Pharmaceutical Technology at Menarini; Mauro Silvestri is in Manufacturing Technology at Angelini; Matteo De Nigris is part of Manufacturing Science and Technology at LEO Pharma Manufacturing; Simona Bertolini and Luca Rizzo are both in R&D CMC at Chiesi; Alessia Garavaglia is in Good Engineering Practices at GrĂ¼nenthal; Camillo Bologna is QP and Rosa Terribile is in QA, both at Mipharm; Stefano Pompilio is in Clinical Trial Manufacturing at Thermo Fisher Scientific; Enrico Modena is in R&D at PolyCrystalLine; Stefano Selva is in Pharmaceutical Technology at Recordati; Lorenza Broccardo is project manager at S-IN Soluzioni Informatiche; Cesare Armetti and Marco Adami* are AFI members. All authors are members of the AFI process validation working group. *To whom all correspondence should be addressed. PHICHAK - STOCK.ADOBE.COM Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1 Francesca Speroni, Ilaria Franceschini, Maurizio Valleri, Mauro Silvestri, Matteo De Nigris, Simona Bertolini, Luca Rizzo, Alessia Garavaglia, Camillo Bologna, Rosa Terribile, Stefano Pompilio, Enrico Modena, Stefano Selva, Lorenza Broccardo, Cesare Armetti, and Marco Adami AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

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