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GMP compliance
Quality is more than a set of rules; it’s a
state of mind.
Hovione has an uncompromising commitment to Quality. Even before 1982, when
the FDA first inspected Hovione, a quality culture was evident within the
Company. We were concerned that all industrial processes and other activities
should be properly managed. The quality of raw materials and intermediates
was controlled by the application of rigorous analytical techniques. Detailed
production batch records were written-up and a double signature system was
instituted.
The final product had to conform to pre-defined standards before release
was authorized. Throughout our history, we have done everything possible
to minimize risk and error.
This was the solid basis on which the Company built its quality system.
Today, Hovione has in place an enviable quality system that gives everyone
who uses our products an extremely high degree of comfort. Nevertheless,
our quality system was recently overhauled as part of our policy of continuous
improvement. A company-wide system now ensures that improvements to the
Quality System are implemented concurrently across all sites at a rate pre-determined
by management. We upgraded our computer systems so that now they are all
21 CFR Part 11 compliant.
Track record in Compliance
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An unblemished record in Compliance and with FDA |
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Hovione quality systems are in compliance with
- ICH Q7a – GMP guideline for APIs
- CFR 21 part II United States regulations |
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First inspected by FDA in Loures in 1982, in Macau
in 1982 and in USA in 1987 |
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Hovione has undergone 17 FDA inspections over a
27-year period |
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No warning letter has ever been issued and, of the
11 Form 483s received, all were addressed satisfactorily within 30
days |
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Total of 10 successful inspections in Loures, 6 in
Macau and 1 in USA |
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The last 8 inspections have been PAI |
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First EP inspection – trial basis –
7, 8 and 9 October 2002 |
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An average of 20 customer audits per year in the
lat 3 years in Loures |
Our past record speaks for itself
Hovione has undergone no fewer than 17 FDA inspections
over a 27-year period. Over the last four years, we have received an average
of only 9 complaints per 400 shipments. Hovione participated voluntarily
in the pilot phase of the European Inspection system that has been set up
to verify compliance with ICH Q7a on cGMP for API manufacture and we are
regularly inspected by the Portuguese Health Authority therefore Hovione
has GMP certificates stating that we are in compliance with ICH Q7a or European
Directive 2003/94/EC Part II as well as with the Annex 13 of the same Directive
applicable to Medicinal Products Under Investigation.
A quality culture built through experience
Experience gained by the QA/QC/Regulatory Affairs
group over four decades has enabled it to acquire considerable expertise
in meeting the requirements for registration of a DMF, or CMC section, for
an API. Our knowledge in this area has helped a succession of clients pass
pre-approval inspections without difficulty. Hovione’s Quality department
is staffed with professionals who have many years of production line and
analytical laboratory expertise. Of the 1000 people we employ, over 100 are dedicated
to quality. To sustain a quality mindset, Hovione invests annually approximately
6% of sales in quality-related activities.
Anticipating trends to stay ahead
Every year, Hovione allocates generous budgets to
upgrade facilities and bring them into compliance with future FDA standards.
Considerable knowledge of cGMP standards helps us to identify emerging trends
so that we can anticipate regulatory changes. We already satisfy requirements
that will not be mandatory until 10-years into the future. Hovione delegates
are closely involved in the standard-setting process. We participate in
ISO committees, Pharmacopeias and industry association work groups. Hovione
is justifiably proud of the fact that it supplies many Pharmacopeias with
Reference Standards of products made routinely at Hovione plants. |
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About Hovione 
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