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Describe what methods are used to test manufactured items for contamination and quality once they have been prepared?
I'm finding this question difficult and it is something I need for my course. I am completely baffled. I need more detail. This is what I have included so far. Most finished products will need to go through the final stage of testing. Final product testing can include sterility and pyrogen testing. These are both used for licensed and unlicensed units. In licensed units, there are samples that are removed from finished products. The samples are then tested, this could be putting the product at risk. This is because the product is going through another form of testing. In this instance users will have syringes that can extract tiny amounts of the medicine in order for it to be tested. However in an unlicensed unit this would not occur as time and patients’ needs will not allow for this process to happen. Another reason why unlicensed units will not do this is that the products only have a seven day expiry time. However, in an unlicensed unit, the patient has the product more or less straight away after it has been made. Of course it has to go through dispensing processes and validation before it reaches the patient. So this then should not contain any microbes on the product, due to the fact that the product is not waiting around. In a licensed unit they have the capacity to make hundreds of batches every day, so ensuring that these batches are monitored is paramount. Unlicensed units are still required to send products for testing though. Testing should involve seeing if there is any microbes on them or any deformities within the product. If there are any deformities or bacterial growth, then these should be thoroughly investigated. The quality controller (QC) has the overall responsibility in providing the environmental and microbiological testing services. The QC must provide them with advice and techniques that go in terms of the procedures and documentation.
Glyn Ruell
spectroscopy and chromatography
Eudora Brekke
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