Analytical Development

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.

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