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

Marco Adami

Knowledge management has always been a key factor for the successful development and manufacture of pharmaceutical products. Understanding the chemical and physical processes underlying material interactions in dosage forms formulation, production processes, and product storage along its shelf-life is fundamental in assuring quality, efficacy, and safety of medicinal products. Knowledge has always directed the design of dosage forms (e.g., in terms of selection of excipients and primary packaging materials) and the development of production processes (e.g., in terms of process technology applied and process controls implemented).

Knowledge is normally assumed to be a combination of education and experience. Advanced education on chemistry, physics, microbiology, biology, analytics, materials properties, process technology, pharmacokinetics, pharmacology, toxicology, and physiology must be available in the pharmaceutical industry. Nowadays this ‘traditional’ form of education has to be integrated with a decent knowledge of information technology, data management, and processing. In addition, highly innovative and specialized areas, like biotech or advanced therapy, require specific knowledge of biochemistry, genomics, and cell engineering.

Pharmaceutical Technology’s October 2021 APIs, Excipients, and Manufacturing eBook

Pharmaceutical Knowledge Management: Experiences in Drug Development and Manufacturing

Pharmaceutical Technology’s APIs, Excipients, and Manufacturing 

Alessandro Regola,* a.regola@libero.it, is the AFI vice president in Milan and coordinator of the AFI Quality Section, and Marco Adami is an AFI member in Milan and coordinator of the Validation Group within the AFI Quality Section. They both serve as pharmaceutical consultants in quality systems and research and development, respectively.
*To whom all correspondence should be sent.

When referring to this article, please cite it as M. Adami and A. Regola, “Pharmaceutical Knowledge Management: Experiences in Drug Development and Manufacturing,” 

Pharmaceutical Technology’s APIs, Excipients, and Manufacturing

Articles

Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years

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.

Pharmaceutical Technology's Regulatory Sourcebook


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

When referring to this article, please cite it as F. Speroni, 

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

Pharmaceutical Technology Regulatory Sourcebook eBook

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.

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

In Part 1 of this work, the AFI (Industrial Pharmacist Association, 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 popularity. 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.


eBook: Regulatory Sourcebook, October 2020
October 2020
Pages: 16–25

, "Enhancing Process Validation for Solid Oral Dosage Forms: Part 2," 

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.