The JETPHARMA GROUP maintains at the highest standards and continually seeks to improve its Total
Quality Management System in its micronization services.
The JETPHARMA GROUP follows the current national regulations, which meet the
requirements of good practice and quality controls recommended
by ICH Q7A: European and US norms.
The facilities and all operations are managed and documented under
a Quality Assurance plan, which is maintained according to current
GMPs and requires that:
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the JETPHARMA GROUP's micronization process and cleaning
procedures are validated;
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equipement and air handling systems are qualified;
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all process operations are fully documented.
The two JETPHARMA GROUPs companies (JETPHARMA SA and MICROCHEM srl),
specialize in contract micronization services, and have 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 GROUP's micronization
facilities.
Internal and external audits are constantly performed to ensure
the highest quality standards.
JETPHARMA SA (Balerna, Switzerland) 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.
MICROCHEM srl (Fiorenzuola d'Arda) is also FDA inspected since 1998 and ISO 9001:2000 (Vision 2000)
and ISO 14001: 1996 (Environmental) certified.
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