Analytical methods will be developed if not available prior to initiating the cleaning validation study for all worst-case products (active ingredients) as designated in the Planning Phase.
The basic requirements are
• Ability to detect target substances at levels consistent with the acceptance criteria
• Ability to detect target substances in the presence of other materials that may also be present in the sample (selectivity)
• An analytical method that includes a calculation to convert the amount of residue detected in the sample to 100% if the recovery data generated indicate a recovery outside of an allowed range
• Stability of samples over time if the time interval between removal and testing of samples potentially affects sample integrity potency.
Was this article helpful?
Thousands Have Used Chemicals To Improve Their Medical Condition. This Book Is one Of The Most Valuable Resources In The World When It Comes To Chemicals. Not All Chemicals Are Harmful For Your Body – Find Out Those That Helps To Maintain Your Health.