Quality Assurance

We are pleased to announce that in the FDA's most recent inspection of our St. Louis, MO facility (November 2009), there was not a single 483 issued. Our Edison, NJ facility was inspected in February 2009 and did not receive any 483s either. Tap into our expertise in CGMP compliance and FDA expectations: we can help.

The AAIPharma quality assurance programs focus on constant scrutiny, feedback and assistance to our analytical operations. This common goal between departments ensures the highest degree of accuracy and integrity for our test results and regulatory compliance.

Quality System

AAIPharma Analytical Services quality systems are founded on one essential element: commitment at the very top. We strive at all levels to maintain our reputation as a leader in analytical testing services.

Certification and Registrations

AAIPharma is CGMP and holds numerous Federal and State registrations

Memberships

AAIPharma Analytical Services is a member of numerous professional and scientific associations

SOPs

The processes that support our quality commitments are detailed in our Standard Operating Procedures (SOPs), which are based on current guidelines of the International Standards Organization (ISO), the U.S. Code of Federal Regulations and proven principles and practices.

Harmonization

AAIPharma supports the increasing harmonization among the US Pharmacopeia (USP), the European Pharmacopeia (EP) and the Japanese Pharmacopeia (JP)