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16 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Process Development I n Part 1 of this work, the AFI (Industrial Pharmacist Associa- tion, an Italian professional association) Working Group on Process Validation has illustrated the concepts, the approaches, and the tools available to implement current vision of process validation for sterile dosage forms. In Part 2, the same concepts can be applied to immediate-release solid oral dosage forms. These forms were chosen considering their worldwide availability and popular- ity. For the sake of simplicity, immediate-release plain tablets are considered in this work; however, the principles and tools described can be applied to coated tablets as well as to other types of tablets and also to other types of finished dosage forms. Quality target product profile (QTPP) and critical quality attributes (CQAs) According to the International Council for Harmonization (ICH) guideline Q8 (1), the QTPP forms the basis of design for the develop- ment of the product. It represents a plan conceived at the beginning of the development stage with the final objective clear in mind (2). Based on the physicochemical characteristics of the drug sub- stance and the general quality attributes of the drug product, the QTPP for several immediate-release solid dosage forms (powders, granules, and tablets) is provided in Table I. Process design According to FDA's guidance for industry on process validation (3), process design is the activity of defining the commercial manufactur- 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 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. ANDRZEJ TOK ARSKI - STOCK.ADOBE.COM Enhancing Process Validation for Solid Oral Dosage Forms: Part 2 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 solid oral dosage forms.