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.
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.