Companies in the FDA-regulated industries frequently have validations with inadequate justification for the number of runs used for process validations. The “rule of three” batches (or runs) is a process typically used by FDA regulated industries for QC testing, process qualification (PQ) runs and process performance qualification (PPQ).
The FDA’s Process Validation: General Principles and Practices (2011) guidance document states that “The number of samples should be adequate to provide sufficient statistical confidence of quality both within a batch and between batches. “ Therefore, defaulting to a general “rule of three” should not be taken as gospel. A tailored approach to establishing the number of runs is critical to achieving the best results.
During this session, we will instruct you on how to pinpoint an adequate number of runs for process validation, and introduce best practices for “getting there” and common pitfalls to avoid.
During the presentation, you will learn about:
- Requirements for validation activities required by certification standards and federal regulations
- Background information around FDA 483 findings and warning letters related to process validation
- Linkage of validation and risk management activities
- Variable and attribute sampling techniques
- Techniques for establishing and justifying the number of validation runs
- The use of non-parametric tests for means and variance to demonstrate statistical confidence of quality between batches