A/S 사업 분야
There is always room for improvement
It is the documented proof that the production plant and the product correspond to the required high quality standards at any time. Here, it is necessary to keep the directions of the EU and of the FDA (GMP standards), to find out entrapments, to access riscs in the right ways and to profit from optimization possibilities.
By means of our outstanding knowledge and experiences, we are supporting you in the smooth handling of the validation works on our process plants.
On the basis of a validation master plan, proceedings and responsibilities are determined – from the Design Qualification (DQ) via the comparison of the installed plants and equipment with flow charts and specifications (Installations Qualification - IQ) as well as functional tests (Operations Qualification - OQ) up to the final Performance Qualification (PQ).
We are supporting these works by arranging all necessary GMP conform documents or, if requested, carry out these works by ourselves in a budget-compliant way.
When carrying out the qualification / validation, we test with the final customer the design, the installation, the functionality as well as the performance of the plant and the corresponding processes based on a detailled risk analysis in the below mentioned phases by means of documents and tests according to the criteria prescribed in the specifications.
Over the past years, the NETZSCH Vakumix has achieved special competence and experiences with the validation of automated plants, e.g. acc. To standard 21 CFR Part 11 "Electronic Records, Electronic Signature" and acc. to GAMP 4.
The term "Qualification" means that plants work perfectly and the expected results are realized in fact. (EU-GMP – guideline)
The “Validation“ mainly refers to methods, processes and computer systems. It is “the proof in accordance with the basics of a good production practise that methods, processes, equipment, material, working steps and systems leads really to the expected results“ (EU-GMP-guideline).