Good Manufacturing Practice

GxP guidelines have been established by the Food and Drugs Administration (FDA) in the United States. Where the "x" means particular field. When your business operates to the GxP regulated industry e.g. pharmacteuticals, your manufacture require compliance with GMP, your logistics with GDP and labatories with GLP etc. Because they aim to ensure that your products are safe, fit for purpose and meeting strict quality standards throughout your entire production process.

Take notice that Höltermann Process Systems can assist you with the system impact assessment to determine the GxP mandatory design criteria, and subsequently with the preparation en execution of the qualification procedure.

Qualification procedure in 5 stages:

1. Collect and evaluate system documentation,
2. Drafting protocols and test plans,
3. Execution of qualification tests,
4. Handling defects and closing Performance Qualification,
5. Complete the qualification.

Höltermann Process Systems
KvK Utrecht 65176510