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Process Validation in Context of Small Molecule DS and DP Continuous Manufacturing Processes
1 January 2019
Authors: Carly Evans (Akebia Therapeutics), Katherine Giacoletti, (SynoloStats LLC), Declan Hurley (Lilly), Robert Ievers [Co-Lead] (Merck), Matthew...
Overview of Packaging Validation for Drug Products
1 August 2017
Numerous guidances are available from regulatory and industry sources concerning process validation; however, very few provide information regarding...
Process Validation Lifecycle Implementation for Existing Products
1 March 2016
Authors: David Dolgin (PSC Biotech), David Hughes (Sandoz), Matthew McMenamin (GSK), Parab Parkash (BMS), Domenico Schiavone (Fresenius-Kabi), Chris...
Determining Number of Process Performance Qualification Batches Using Statistical Tools
1 January 2016
Prior Discussion Paper: “Topic 1 – Stage 2 Process Validation: Determining and Justifying the Number of Process Performance Qualification Batches...
Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations
5 November 2015
Authors: Robert Beall (ProPharma Group), Penny Butterell (Pfizer), Kurtis Epp (CSL Behring), Lois Hintz (Corden Pharma), Russell Miller (Lilly), Rusty...
Impact of Statistical Tools on Process Performance Qualification
1 August 2014
In 2011, FDA issued a “Guidance for Industry Process Validation: General Principles and Practices Guidance”, which calls for a lifecycle approach to...
Lifecycle Approach to Biotech Process Validation
1 August 2014
This discussion paper proposes ideas for answering the questions about the application of the lifecycle approach to PV to Biotech product...
Stage 2 Process Validation: Process Performance Qualification Batches
1 February 2014
Authors: Mette Bryder (Lundbeck), Harold Etling (Eli Lilly), Jeff Fleming (Pfizer), Yanhui Hu (Abbott), Peter Levy (PL Consulting) 1 Introduction...
Stage 3 Process Validation: Applying Continued Process Verification Expectations
1 August 2012
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and testing following PPQ determined, as part of the...