Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1

October 16, 2020
Francesca Speroni

Francesca Speroni is project leader at PTM Consulting and is a member of the AFI process validation working group.

,
Ilaria Franceschini

Ilaria Franceschini is in Pharmaceutical Technology at Italfarmaco and is a member of the AFI process validation working group.

,
Maurizio Valleri

Maurizio Valleri is in Pharmaceutical Technology at Menarini and is a member of the AFI process validation working group.

,
Mauro Silvestri

Mauro Silvestri is in Manufacturing Technology at Angelini and is a member of the AFI process validation working group.

,
Matteo De Nigris

Matteo De Nigris is part of Manufacturing Science and Technology at LEO Pharma Manufacturing and is a member of the AFI process validation working group.

,
Simona Bertolini

Simona Bertolini is in R&D CMC at Chiesi and is a member of the AFI process validation working group.

,
Luca Rizzo

Luca Rizzo is in R&D CMC at Chiesi and is a member of the AFI process validation working group.

,
Alessia Garavaglia

Alessia Garavaglia is in Good Engineering Practices at Grünenthal and is a member of the AFI process validation working group.

,
Camillo Bologna

Camillo Bologna is QP at Mipharm and is a member of the AFI process validation working group.

,
Rosa Terribile

Rosa Terribile is in QA at Mipharm and she is a member of the AFI process validation working group.

,
Stefano Pompilio

Stefano Pompilio is in Clinical Trial Manufacturing at Thermo Fisher Scientific and is a member of the AFI process validation working group.

,
Enrico Modena

Enrico Modena is in R&D at PolyCrystalLine and is a member of the AFI process validation working group.

,
Stefano Selva

Stefano Selva is in Pharmaceutical Technology at Recordati and is a member of the AFI process validation working group.

,
Lorenza Broccardo

Lorenza Broccardo is project manager at S-IN Soluzioni Informatiche and is a member of the AFI process validation working group.

,
Cesare Armetti

Cesare Armetti is an AFI member and participates in the AFI process validation working group.

,
Marco Adami

Marco Adami is an AFI member and participates in the AFI process validation working group.

Pharmaceutical Technology, Pharmaceutical Technology-10-15-2020, Volume 2020 eBook, Issue 3
Page Number: 4–15

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).

About the Authors

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.

Read this article in Pharmaceutical Technology's Regulatory Sourcebook October 2020 eBook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, October 2020
October 2020
Pages: 4–15

Citation

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).