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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.
The AFI (Industrial Pharmacist Association) is an Italian professional association aiming to promote cultural initiatives and practical/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 manufacturing 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).
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.
eBook: Regulatory Sourcebook, October 2020
When referring to this article, please cite it as F. Speroni, et al., "Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1," Pharmaceutical Technology Regulatory Sourcebook eBook (October 2020).