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