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www.biopharminternational.com October 2020 BioPharm International eBook 31 Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms 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. T he AFI (Industrial Pharmacist Association) is an Italian professional association aiming to promote cultural initiatives and practi- cal/professional updating for its members within the pharmaceutical industry. This article 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 design up to the validation and maintenance of the state of control. According to these concepts, drug product quality is generated starting from the initial development phases, is defined in the manu- phichak - stock.adobe.com FRANCESCA SPERONI is project leader at PTM Consulting; IL ARIA 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 Grünenthal; 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. 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 Regulatory Sourcebook Process Development