GXP

Cleaning Validation Residue Limits–How Clean is Clean?

INTRODUCTION Residue limits for cleaning, cleaning validation, and numerous associated considerations continue to be a confused, misinterpreted, and generally misunderstood topic of discussion among global validation personnel. Support for this assertion may be found on the US Food and Drug Administration website listing of frequent FDA-483 observations. Cleaning/sanitization/maintenance (Code of Federal Regulations Title 21 Part 211.67) was among the 10 most cited observations for drug inspec

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