The ICMRA collaborative hybrid inspection pilot (CHIP)
by Giuliana Miglierini Hybrid inspections emerged during the pandemic as a new way to approach the assessment of…
A concept paper on the revision of Annex 11
This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP)…
The FDA warns about the manufacture medicinal and non-pharmaceutical products on the same equipment
by Giuliana Miglierini A Warning Letter, sent in September 2022 by the US FDA to a German company…
Trends in Drug delivery and Formulation
by Giuliana Miglierini According to the 2021 Global Drug Delivery & Formulation Report, signed by Kurt Sedo, Vice…
Revision of the CDMh’s Q&As document on nitrosamine impurities
by Giuliana Miglierini The review process of medicinal products started in 2018 to assess the presence of nitrosamine…
Automation of aseptic manufacturing
by Giliana Miglierini The pharmaceutical industry is often the last industrial sector to implement many new manufacturing and…