Quality and Compliance
Count on us—and our proven compliance record—to move your project forward reliably
At AAIPharma Services, our Quality Systems are designed to maintain our compliance with a host of local, state and federal regulatory requirements, as well as various industry and international standards and guidelines where applicable. Our primary focus is compliance with current GMPs and GLPs as required by regulation and guidelines by numerous countries including the US, Canada, European Union and EU Member State regulatory bodies (e.g. EMA, MPA, IMB). In addition, there are various internationally accepted guidelines that apply to our operations such as those recommended by the International Conference on Harmonization (ICH), the Pharmaceutical Inspection Convention (PIC), the World Health Organization (WHO), the International Standard Organization (ISO), and various pharmacopeias including the USP, EP and JP. Where applicable, we also operate in compliance with regulations and standards regarding controlled substances (DEA), radioactive materials (NRC), chemical and pharmaceutical wastes (EPA), child-resistant container-closures (CPSC) and employee safety (OSHA) among others. Of course wherever we operate, we must be prepared for inspections against various state and local requirements. For example, our operations in Wilmington, NC have been inspected by the NC State Department of Agriculture.
A word about quality from AAIPharma Services' Vice President, Quality and Regulatory Affairs:
For more than 30 years AAIPharma Services has maintained an outstanding record of GMP compliance. In that time, we have never received a significant 483, Notice of Adverse Findings or Warning Letter, or failed a Pre-Approval Inspection. Our facilities have also received certifications from European regulatory authorities for compliance with EU GMPs.Recent Inspection History December 2009 – FDA GMP – Wilmington manufacturing, labs and stability – No 483 June 2009 – FDA GMP – Charleston sterile manufacturing – No 483 August 2008 – EU GMP – Wilmington laboratories – Certification August 2008 – FDA GMP – Chapel Hill analytical labs – No 483 April 2008 – EU GMP – Wilmington manufacturing, labs and stability – Certification We have an open invitation to all our clients to visit our facilities and see first hand how our commitment to quality is their path to project success.
