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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...
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...
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...
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...