Quality by Design (QbD): A New Horizon For Robust Analytics in Extractable and Leachable Study For Packaging Components
Keywords:
CQA, CCS, QbD, Extractables, Leachables, PQRI, AETAbstract
When drug products is packed in plastic container systems, chemical entities may leach from the container and accumulate in the product thereby causing an increase in the toxicity of the drug product. It is necessary that the drug product's manufacturer demonstrate that any such leaching does not occur to the extent that the leached substances adversely affect the product's safety and / or efficacy. One method for accomplishing this objective is via analysis of the drug product to identify and quantify the leached substances. When a particular packaging system is utilized for multiple drug products, one reaches the point, after testing numerous drug products, where the leaching properties of the packaging system are well known and readily predictable. The Quality by Design (QbD) principle can be simply stated as follows - once a system has been tested to the extent that the test results are predictable, further testing can be replaced by establishing that the system was operating within a defined design space.
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