FDA’s Guidance for Industry: “Process Validation: General Principles & Practices” has been available since 2011. The guidance details FDA’s expectations for process validation. Seven years later, companies are still not completely comfortable with their understanding of current expectations, and it shows in detailed regulatory observations. Even though the guidance is fairly straightforward, firms have been slow to adopt many of its elements, which can lead to non-compliance.
If you are still talking about IQ/OQ/PQ and the “Rule of 3,” this course is for you!
This interactive session will provide an overview/discussion of significant portions of the guidance and the underlying rationale driving these current expectations, including:
- The relation of process validation to drug quality, and linkages to the current quality by design and pharmaceutical quality systems thinking
- The current thinking about approaching process validation, when it’s done and what it encompasses
- Recommendations for process validation – including what happened to the IQ/OQ/PQ and the “Rule of 3”
- When it goes wrong – FDA inspectional observations relating to process validation