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.
JETPHARMA has submitted a Drug Master File Type II
to the US FDA. The file is available for reference to support contract
processing operations. The US FDA has carried out several Pre-approval
and General GMP inspections and regularly inspects JETPHARMA's micronization
facilities.
Internal and external audits are constantly performed to ensure
the highest quality standards.
JETPHARMA has passed all the FDA inspections since
1995, is Swissmedic inspected, ISO 9001:2000 (Vision 2000) certified,
and is implementing the Environmental ISO 14001:1996 Certification.
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