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Article / Jan 01, 2006

EU To Begin ICH Q7A Enforcement

“The Gold Sheet”, Vol. 40, No. 1, January 2006

NEW EU REQUIREMENTS FOR API GMP OVERSIGHT are now in force calling for finished product manufacturers to audit their bulk suppliers and attest to their GMP compliance. With global implications, European regulators and industry have been debating how to create an effective implementation approach, and a flurry of guidances and position papers is emerging. The EU industry views authority inspections as a critical enforcement lever in the effort to achieve fairer competition with Asia and more control over API quality. [A detailed explanation by a European regulatory official of the new API GMP legislation and implementing measures and the impact on the obligations of application holders, API manufacturers, and regulatory authorities is provided on pp. 19-23. A recent release from the EMEA focusing specifically on the expectations for API auditing by dosage manufacturers is included on pp.3-4.] 

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In an interview with Executiva, a portuguese media outlet focused on women´s leadership, Diane Villax, co-founder and long-standing leader of Hovione, reflects on her journey and the company’s development over more than six decades. Diane Villax’s career began at a time when few women worked outside the home. At 19, she joined a trading company as a foreign languages correspondent, where she developed essential business skills — including commercial correspondence, banking and export procedures — that later proved instrumental in helping her husband, Ivan Villax, establish Hovione in 1959. From its earliest days operating in the family home in Lisbon, Hovione adopted an international outlook. The company’s first major customers were in Japan, setting demanding quality standards that helped shape its long-term position in global markets. Over the following decades, Hovione expanded its footprint with the construction of its first manufacturing site in Loures (1969), followed by expansion to Macau (1986), the United States (New Jersey, early 2000s) and Ireland (Cork). The company grew into a global organization with more than 2,500 employees — including over 300 scientists — and a reputation as a preferred supplier to leading pharmaceutical companies worldwide. Throughout the interview, Diane highlights the values that have guided the company’s development: a commitment to excellence, a strong work ethic, and a focus on quality and long-term relationships. Although she did not have formal business training, she learned “on the job” and brought discipline, precision and structure to her role — particularly in the company’s early financial and administrative leadership. Now in her nineties and an active member of Hovione’s Board of Directors, Diane Villax remains engaged with the company’s evolution and governance, reflecting a continued commitment to its long-term development. Her story reflects entrepreneurial drive, resilience and long-term leadership — and offers insight into the values that have shaped Hovione’s trajectory for more than six decades. Read the full interview at Executiva.pt (in portuguese).    

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