Qualification of Cleaning Disinfectants while under a Consent Decree

Situation: Our client was operating multiple manufacturing sites which had not qualified their cleaning disinfectants to FDA requirements, and as a result were under a consent decree to complete these qualifications within a year. The client had simply never demonstrated that their current procedures were effective. As a result, the client approached AAIPharma to assist in this major effort.

Task: We were charged with validating all cleaning and sanitization methods in multi-national sites on multiple surfaces using a number of different agents within an eight month time frame.

Action: The scope of the project was immense from acquiring the materials to performing the testing, developing the protocols, to the coverage of each site. The project was assigned to four AAIPharma scientists that worked on the project full time for eight months. A kickoff meeting was held with client representatives from each site to review and conduct training. The work was initiated in several stages. Clients visited the AAIPharma facilities every three weeks during the project to review the data. This process went on for the entire eight month time frame and was truly a team effort and partnership between the client and AAIPharma.

Result: AAIPharma was able to complete the project a month ahead of schedule which allowed the client to review the data, summarize it and present it to FDA. Upon review, FDA lifted the consent decree. With the scope of this project and others like it, AAIPharma has become recognized as the leader in this work.