A gap in the effective cleaning procedures raises critical concerns over the integrity of product quality, safety and efficacy, in just the same way critical data integrity issues result from a gap in data. The perception in validation circles that cleaning validation is a generic version in the list of validations may not be right, since cleaning validation requires the use of different Acceptance Criteria for deciding the effectiveness of cleaning. Having said this, cleaning validation professionals are left wondering how to fix issues, how effective the correct approach is, how to design and perform the cleaning validation studies, etc. How valid are the traditional concepts in the light of changing expectations from the regulatory agencies? The way out is to employ a risk based approach to design a cleaning validation plan, as the rationale and procedures being used by most companies are turning out to be low on reliability. A meaningful learning session from Traininng.c...