Press Room

Press Release / Jun 08, 2001

FDA inspection to Hovione site in Loures, Portugal - May 31st to June 5th

An FDA pre-approval inspection took place in Hovione's Loures facility from 31st May to 5th June. Mr. Charles Cote, FDA investigator of the Minneapolis District, stated at the closing meeting that no Form 483 would be issued. Mr. Cote made a general inspection of our quality system, procedures and controls and reviewed in detail the key PAI documentation relating to process validation, cleaning validation, analytical validation, stability testing, batch production and analytical records, raw material approvals.

He also reviewed an Annual Product Quality Report for one of our established products, the list of products sent to the U.S. since our last inspection together with the list of complaints and current status. Purified water systems, cleanroom design and controls and microbiological testing were covered as well as a review of analytical and production equipment qualification as part of the inspection of the operational areas.

At the closing meeting, Mr. Cote also stated that he was impressed with all of the people with whom he interacted at Hovione. Records were available for all the areas he wished to cover and the Standard Operating Procedures were generally well written. He stated that Hovione had good control over our operations and he thanked our staff for our cooperation with him during the audit.

Hovione is an international group dedicated to the synthesis of APIs and serving exclusively the Pharma industry. With FDA inspected plants in Europe and the Far East and sales offices in Hong Kong, Switzerland and New Jersey, Hovione is committed to the highest levells of service and quality. Hovione’s capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP standards.The company also has ISO 9000 certified Quality Management Systems.

Hovione was first inspected by the FDA in 1982 and has been successfully inspected regularly ever since. Quality operations at Hovione involve 82 staff, including QA, Regulatory Affairs, QC and the Analytical Group, with dedicated laboratories for Release, In-process Control, Method Development and Validation.

The Company is involved in establishing Industry Standards and actively participating in CEFIC/APIC and pharmacopoeial committees. Analytical methods developed in Hovione’s laboratories have been included in pharmacopoeial monographs and the Company regularly supplies EP and USP with substances used as International Reference Standards. Hovione's commitment and investment in the areas of quality, compliance and regulatory issues frequently result in the Company adopting new standards prior to their official implementation. Hovione has filings with every world health authority that has a DMF system for APIs. The Regulatory Group is able to prepare data for an IND, NDA, ANDA, VMF or DMF filed at the FDA, MCA, HPB, TGA, Agence du Médicament, BfArM, or for EP certification.

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