CRED Managing Variations Effectively

Chapter A - Remarks (II)

Scopes A.4 & A.5 • Changes of address or name of a manufacturing site or a site performing quality control (e.g. rename of the street or change of post code, administrative change of the name); • This scope cannot be used for a site transfer. In this case the relevant scopes under section B apply (e.g. B.I.a.1, B.II.b.1, B.II.b.2).

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Introduction to Classification of CMC (Quality) / Clinical / PhV Variations