JETPHARMA maintains and continually seeks to improve
its Total Quality Management System for the micronization services.
JETPHARMA follows the current Swiss regulations, which meet the
requirements of good practice and quality controls recommended by
ICH Q7A: European and US norms.
The facility and all operations are managed and documented under
a Quality Assurance plan, which is maintained according to current
GMPs and requires that:
-
JETPHARMA's micronization process and cleaning procedures
are validated;
- Equipment and air handling systems are qualified;
- All process operations are fully documented.
Internal and external audits are constantly performed to ensure the highest quality standards.
The US FDA has carried out several Pre-approval and General GMP inspections and regularly inspects JETPHARMA's micronization facilities.
Jetpharma is authorized and regularly inspected by Swissmedic and is ISO 9001 certified.
Jetpharma has obtained the Accreditation of Foreign Manufacturer by Japenese MHLW.
