The change is GxP-relevant if it has a potential impact on product quality. This is checked on the basis of the following points:
The result of this assessment is documented in an amendment.
It is important to also document the decision "change is not GxP-relevant" and archive it in the system. This way, for example, it can be proven during audits or inspections that all changes are systematically recorded and evaluated and that an "informally" implemented change is not based on a lack of compliance but on a consciously made and documented decision.
Examples of GxP-relevant changes are (list not exhaustive)
The text is a translated excerpt from the knowledge portal in German language GMP:KnowHow Pharmalogistik (GDP): SOP-120-001-01 "Änderungskontrolle (Change Control)“, chapter 6.4.1.
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