Chemika has been serving Australian pharmaceutical manufacturers for nearly 20 years, offering a high quality, independent chemical testing laboratory service. We have an outstanding team of scientists that bring breadth and experience from around the world. Our experience covers a diverse range of international compendial methods for chemical analysis including BP,EU, JP, USP as well as customer supplied methods. We work with every step of the way, from the analysis of Raw Materials and Active Ingredients, Finished Products and Release For Sale, Stability Evaluation through to ad hoc and Special Projects as required.
Manufacturers and sponsors of therapeutic goods may outsource comprehensive chemical testing of raw materials or finished products, or may require an independent pharmaceutical chemical testing laboratory for individual tests which their control laboratories are not equipped to undertake. Chemika is able both to offer comprehensive testing, or highly specialised testing. Routine chemical analysis using HPLC and GC are covered by the wide variety of detector configurations available. In addition to this chemical analysis, Chemika is able to undertake trace metal chemical testing using sealed digestion and ICP-OES, or the detection of traces of residual solvents, ethylene oxide or 2-chloroethanol in raw materials and finished products by headspace GC or headspace GCMS.
Some pharmaceutical chemical testing laboratories may not be limited by their equipment, but may outsource difficult tests when they are only performed rarely. Chemika has implemented a number of difficult to perform methods, benefiting from servicing a number of manufacturers meaning that these tests become routine and performed on a regular basis. Interpretation of test results often requires consideration of validation or method transfer data. Chemika is able to undertake validation to the requirements of the ICH, including stress testing of the analyte to demonstrate the specificity of the method for the analyte in the presence of breakdown products. Chemika is able to validate related substances methods, and can also develop and validate complimentary methods where for example, more than one method is required to determine analyte stability. We are also able to develop intelligent protocols aimed at demonstrating successful transfer of methodology to our chemistry laboratory, either from compendial or client supplied methods.
Chemika is committed to Quality, we understand control of retesting and revision of results is critical to the integrity of data generated by a laboratory. Sound retest protocols prevent the possibility that out of specification product is released for sale due to an ad-hoc analytical review or retest procedure. Chemika understands release of out of specification product can result in large costs of recall and possible risks to consumers. Test investigation procedures at Chemika are aimed at gathering data which allows the evaluation of results using sound scientific reasoning, resulting in either revision of the result or confirmation of initial chemical testing.
Chemika has a breadth of experience in the chemical analysis of human therapeutics. This experience can be used to develop and implement cleaning validation protocols, using TOC analysis with associated swab recovery measurements. We can also assist in developing limits for the control of impurities, such as residual solvents according to the ICH Guideline - Residual Solvents.
Working with Chemika, you’re supporting a team with principles, dedicated to meeting your goal of improving the health and happiness, of all people, with nearly 20 years of experience in the area of pharmaceutical testing. Delivering results when you need them.
We look forward to hearing from you. Please contact us now to discuss your analytical requirements.