Quality and Compliance
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. MHRA, MPA BfArM). 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's Vice President, Quality and Regulatory Affairs:
For more than 30 years AAIPharma 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.
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.
To find out more or request an audit of our facilities click on this link:
