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RE: Reference Std.

Contribution from Lance Smallshaw written on 6/26/2008 at 11:31

Original contribution: Reference Std. written by Ana Madrid on 6/25/2008 at 14:38)

Hi Ana, Normal practice is to 'point' (e.g. potency) your in-house reference standard against a primary recognised compendial (or other e.g. WHO), so your in-houise standard becomes an in-house secondary standard. Your in-house secondary standard must have a standard profile containing all the pertinent information /tests to characterise fully characterise it. Thias standard must be periodically reevaluated vs. expiry. If this standard is used across different company sites, include them in your, well designed standard reevaluation study.

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