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Quality

Chemical Analysis is a TGA and APVMA licensed testing laboratory. It is cGMP certified for physical, chemical, and microbiological testing including sterility and LAL (endotoxins) testing of sterile and non-sterile products. Chemical Analysis is also a FDA inspected site which complies with the FDA Code of Federal Regulations Title 21 for Drugs and Finished Pharmaceuticals.

Our Quality System is based on the current PIC/S Guide to Good Manufacturing Practice for Medicinal Products, TGA guidelines and default standards (current BP, EP, USP), FDA 21 CFR Part 210/211 and guidance for industry, ICH guidelines and ISO/IEC 17025 general requirements for the competence of testing and calibration laboratories.

In addition to periodic self and regulatory inspections, we host numerous client GMP inspections annually as part of our clients’ vendor assurance programmes.

Chemical Analysis maintains the following licenses:

Our Chemical Analysis Quality Policy can be found here.