CRED Managing Variations Effectively

Variations Guidelines – Classification of variations ● Variation guideline classifies many types of common changes: – >90 types of change/variation are listed. – Each change is assigned a classification category – Exact category is dependent on the type of change, type of product and whether certain pre-defined conditions can be met – Time for assessment, required supporting documentation and fee are dependent on category assigned ● Variation guideline covers: – Administrative changes – Quality changes (Drug substance, Drug product, Devices, CEP) – Safety, efficacy, pharmacovigilance changes – PMF/VMF