Good Manufacturing Practice

Direct impact pharmaceutical production systems require compliance with GMP rules. Höltermann Process Systems can assist you with the system impact assessment to determine the GMP mandatory design criteria, and subsequently with the qualification procedure from Design Qualification upto the Installation Operation Commissioning protocols and handover for validation resp. the product registration.

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