Discussion Papers

Authors: Carly Evans (Akebia Therapeutics), Katherine Giacoletti, (SynoloStats LLC), Declan Hurley (Lilly), Robert Ievers [Co-Lead] (Merck), Matthew...

Numerous guidances are available from regulatory and industry sources concerning process validation; however, very few provide information regarding...

Authors: David Dolgin (PSC Biotech), David Hughes (Sandoz), Matthew McMenamin (GSK), Parab Parkash (BMS), Domenico Schiavone (Fresenius-Kabi), Chris...

Prior Discussion Paper: “Topic 1 – Stage 2 Process Validation: Determining and Justifying the Number of Process Performance Qualification Batches...

Authors: Robert Beall (ProPharma Group), Penny Butterell (Pfizer), Kurtis Epp (CSL Behring), Lois Hintz (Corden Pharma), Russell Miller (Lilly), Rusty...

In 2011, FDA issued a “Guidance for Industry Process Validation: General Principles and Practices Guidance”, which calls for a lifecycle approach to...

This discussion paper proposes ideas for answering the questions about the application of the lifecycle approach to PV to Biotech product...

Authors: Mette Bryder (Lundbeck), Harold Etling (Eli Lilly), Jeff Fleming (Pfizer), Yanhui Hu (Abbott), Peter Levy (PL Consulting) 1 Introduction...

This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and testing following PPQ determined, as part of the...