Change Control at the Wholesaler or Logistics Provider: Assessment of GxP Relevance

The change is GxP-relevant if it has a potential impact on product quality. This is checked on the basis of the following points:

• Effects on the qualification status of an equipment or premise
• Effects on the validation status of a system
• Effects on the course of a process

The result of this assessment is documented in an amendment.

• If the change is not GxP-relevant, it may be implemented without further change control. The assessment is confirmed with date and signature in the change request and the change request is filed as version 01. The process ends at this point.
• If the change is GxP-relevant, the further change control process must be gone through.

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

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.