At AAIPharma, our Quality Systems are designed to maintain our compliance with a host of Local, State and Federal regulatory bodies as well as various industry and international standards/guidelines where applicable.
Our primary focus is compliance with current GMPs, GLPs and GCPs as required by regulation and guideline by numerous countries including the US, Canada, European Union, EU Member State regulatory bodies (e.g. MHRA, MPA BfArM), countries in Central and South America (e.g. ANVISA), South Africa and those in Eastern Europe where and when we are conducting any operations.
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-protective container-closures (CPSC) and employee safety (OSHA) among others.
Of course, wherever we operate we also must be prepared for inspections against various State and local requirements. For example, our operations in Wilmington, NC have been inspected by the NC Department of Agriculture, our operations in Shawnee, KS have been inspected by the Kansas Department of Health and the Environment Bureau of Air and Radiation, and our operations in Neu-Ulm, Germany have been inspected by the Regierung von Schwaben, the State agency responsible for evaluating compliance to the Federal German Drug Law.
