Testing to Release for Sale

Testing for release of sale presents challenges for any laboratory, whether internal or external. The laboratory must work with production deadlines and have reference standards, reagents, equipment and methodologies in place to allow products to be manufactured and delivered to markets on time. Ideally laboratory testing results in no delay of release of the product. By working with our clients Chemika will aim to optimise the testing and reporting procedures to get as close to the "no delay" ideal as possible.

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Testing for release is considered by the TGA and APVMA to be a step in the manufacturing process and contract testing laboratories are issued a single step manufacturing license to cover this operation. It is the pharmaceutical laboratories performance at release testing which is audited by regulators and based on their evaluation licenses are granted or revoked.

Release testing is therefore highly scrutinised by the regulator. Regulatory matters however are trivial in terms of the laboratories responsibility when the impact of a product recall or public health consequences are considered. A laboratories failure to detect out of specification product and the subsequent release of this product for sale can result in huge commercial cost and a risk to public health. This means that choice of external laboratory is a critical decision for any business, and Chemika has worked hard to become the laboratory of first choice for chemical testing for release.

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. Our modern pharmaceutical laboratory in Sydney has seen Chemika evolve to become the chemical testing laboratory of first choice in Australia. 

We look forward to hearing from you. Please contact us now to discuss your analytical requirements.