Quality Systems

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

Articles

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

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.

Enhancing Process Validation for Solid Oral Dosage Forms: Part 2

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Using Analytical Assays to Ensure Biosimilar Quality

Dissolution testing is an important aspect of drug development as it provides stability parameters and helps predict drug behavior in-vivo. 

Defining Drug Stability with Dissolution Testing

Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.

Using Industry 4.0 to Optimize Oral Solid Dosage Form Manufacturing

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

Tools help improve understanding of excipient risk in formulating OSD drugs.

Mitigating Risk in Formulating with Excipients

Agnes Shanley is senior editor of Pharmaceutical Technology.

Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset. 

Getting to the Root of Quality Problems

Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development.

Design of Experiments Gains Ground in Biopharma Development

Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.

Moving from Compliance to Quality

Sean Milmo is a freelance writer based in Essex, UK.

Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.


Quality by Design