ICH Q12 Examples – Pharmaceutical Product Lifecycle Management Examples – FDA Guidance
...
Quality in Pharmaceutical Industry – Literature Review
Quality in the Pharmaceutical Industry – A Literature Review Here is a Literature Review on the topic of Quality in the Pharmaceutical Industry. It is not specific to Quality by Design (QbD) or (Process Analytical Technology) PAT. However the literature review does have a small section on both QbD...
Pedro Hernandez – A Tribute to QbD and PAT Evangelist
Our fellow QbD evangelist – passed away this month. He will be missed by many of us. My friend, Mehtap Saydam suggested we reflect on Pedro’s contribution as a community with Pedro’s family at this time. Pedro presenting at a conference Urn of Pedro with his family...
QbD for Pharmaceutical Legacy Products
How do you apply Quality by Design for pharmaceutical legacy products? Today, my good friend, Alicia Tebar of ISPE Spain share her QbD project on legacy products – using QbD and Six Sigma tools. Quality by Design is different from Six Sigma – but they do share many tools....
QbD and PAT Topics at IFPAC 2014
Which QbD or PAT topics interest you? I’ll be attending the IFPAC 2014 Conference in Washington DC. IFPAC began in 1987 and is relatively a small community of Regulatory Agencies, Manufacturers and Researchers focusing on Process Analytical Technology (PAT), Quality by Design (QbD), Process Understanding & Control, and Real-Time Analytics. Sharmista Chatterjee, Ph.D....