Since the introduction of the “The Pharmaceutical Quality System” (ICH Q10) in 2008, the lifecycle approach has been applied to all aspects of pharmaceutical products and processes. In 2011, the FDA issued its Guidance for Industry, Process Validation: General Principles and Practices. This guidance integrates quality system concepts from ICH Q8, ICH Q9 and ICH Q10, including the lifecycle and identifies the three stages of the process validation lifecycle.
In order to optimize performance through the lifecycle concept, it’s important to understand the contemporary expectations for process validation and how these support the quality system approach to compliance. Additionally, this will help your process validation team integrate a lifecycle approach into the development and validation of new processes and the verification of the validation of old processes.
Join expert speaker John G. Lanese
for our special Pharma Process Validation Virtual Boot Camp
, where attendees will learn about the background of process validation from the FDA Process Validation Guidance of 1987 to the regulatory expectations of today, as identified in the 2011 FDA Process Validation Guidance and the EU GMPs. The discussion will show how these validation specific documents relate to:
- ICH Q8, Pharmaceutical Development
- ICH Q9, Quality Risk Management
- ICH Q10, The Pharmaceutical Quality System
- ICH Q11, Development and Manufacture of Drug Substances
- USP Stimulus article on Test Method Validation
- FDA Guidance – Quality Metrics