CRED Managing Variations Effectively

Example of Type IB ‘Default’ Variation

Variation Proposed Variation Type

Category Rationale for category/Grouping

Section 3.2.S.2.2 Adjustment of target flow rates for chromatography columns for a biologic

IB B.I.a.2.a Condition 5 is not fulfilled. Amend registered details to a different target flow rate, within the currently assigned operating range, to ensure that the pressure within the respective columns prevents risk of the column pack being compromised. Column flow rates are considered as non- critical parameters, and the changes do not impact safety or quality.