Discussion Papers

Guidance Docs
Authors: Carly Evans (Akebia Therapeutics), Katherine Giacoletti, (SynoloStats LLC), Declan Hurley (Lilly), Robert Ievers [Co-Lead] (Merck), Matthew...
Guidance Docs
Numerous guidances are available from regulatory and industry sources concerning process validation; however, very few provide information regarding...
Guidance Docs
Authors: David Dolgin (PSC Biotech), David Hughes (Sandoz), Matthew McMenamin (GSK), Parab Parkash (BMS), Domenico Schiavone (Fresenius-Kabi), Chris...
Guidance Docs
Prior Discussion Paper: “Topic 1 – Stage 2 Process Validation: Determining and Justifying the Number of Process Performance Qualification Batches...
Guidance Docs
Authors: Robert Beall (ProPharma Group), Penny Butterell (Pfizer), Kurtis Epp (CSL Behring), Lois Hintz (Corden Pharma), Russell Miller (Lilly), Rusty...
Guidance Docs
This discussion paper proposes ideas for answering the questions about the application of the lifecycle approach to PV to Biotech product...
Guidance Docs
In 2011, FDA issued a “Guidance for Industry Process Validation: General Principles and Practices Guidance”, which calls for a lifecycle approach to...
Guidance Docs
Authors: Mette Bryder (Lundbeck), Harold Etling (Eli Lilly), Jeff Fleming (Pfizer), Yanhui Hu (Abbott), Peter Levy (PL Consulting) 1 Introduction...
Guidance Docs
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and testing following PPQ determined, as part of the...