Collaboration Leads to World-Wide Disinfectant Qualification and Lifting of FDA Consent Decree - Sponsored Whitepaper

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AAIPharma Services Corp.
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Collaboration Leads to World-Wide Disinfectant Qualification and Lifting of FDA Consent Decree

Challenge Having not qualified its disinfectants to FDA standards, a pharmaceutical company was under a consent decree to do so within the year. To achieve this goal, the company contracted with AAIPharma Services to acquire the testing materials, develop and execute the protocols and cover each of its multiple manufacturing sites within eight months.

Solution The full-time equivalent project involved qualifying all disinfectants used by domestic and international manufacturing sites. AAIPharma Services assigned three specialized scientists to work closely with client representatives from each site. The scientists initiated the workload in several stages and conducted training sessions for each of the sites. This close partnership continued throughout the eight months; clients visited the AAIPharma Services facilities every three weeks to review project data.

Results Despite the immense scope of the project, AAIPharma Services was able to:

• Complete the assignment one month ahead of schedule. • Give our clients extra time to review and summarize project information. • Provide data that was successfully presented to the FDA and resulted in lifting of the consent decree. • Project was completed within budget.
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