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GMP and HSE compliance
Throughout its history, Hovione has consistently exceeded
all regulatory requirements for quality. We implement new regulations long
before they become legally mandated. We are involved in setting industry
standards. We participate in ISO committees, and supply many pharmacopoeias
with reference standards.
Our global IT-based compliance system underlines the fundamental quality
and integrity of Hovione’s worldwide operations. All computer systems
are CFR21 part 11 compliant. Our unblemished track record in compliance
speaks for itself: 15 successful inspections by the FDA since our facilities
were first approved in 1982, and over 30 customer audits a year.
Our regulatory affairs department can handle all regulatory requirements
and filings for IND and NDA (DMF or CMC sections) worldwide. Hovione has
over 80 DMFs filed, and submissions are now done electronically. The last
7 FDA inspections have been PAI inspections, all resulting in product approvals.
Hovione has implemented comprehensive HSE systems and processes. A team
of 25 experts ensures correct safety and environmentally friendly procedures
are applied at all levels of operations. Legislation affecting our industry,
such as PORD, elincs, REACH, and GHS, is carefully analyzed and the appropriate
measures are implemented to ensure compliance. Today both of our manufacturing
sites are ISO 14000 certified and the New Jersey facility has recently been
distinguished to integrate the OSHA VPP (Voluntary Protection Program).
For more information on:
GMP compliance – click
here
HSE compliance – click
here
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