As a reliable partner of pharmaceutical industry manufacturers around the world, Minebea Intec invests heavily and constantly in testing and certification in accordance with various national and international standards and regulations, such as
- for materials and products: EHEDG / FDA / HACCP / IFS / EAC
- for Ex applications (explosion protection): ATEX / FM / CSA / IECEx / EAC
- for calibration: OIML / NTEP
- for ingress protection (IP): up to IP69k
- for manufacturing: Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP) – e.g. to FDA 21 CFR
We also ensure compliance, in relation to electronic records and electronic signatures, with FDA 21 CFR Part 11.
We are thus well prepared to meet the widely varying needs of pharmaceutical industry manufacturers, whatever their product or field of activity – and, of course, to provide the associated quality documentation that might be required for any project.