13 HPLC method development in late phase pharmaceutical development

摘要: Abstract Method development is a process in which both the lab and receiving have to work closely order generate test method description that well documented, easily understood, simply performed by an appropriately trained analyst. Within quality control (QC) environment it not important scientifically most fancy method, but technically straightforward, ready-to-use robust, durable, good manufacturing practice (GMP) -compliant preferred. After successful development, validation, transfer, should still be kept accountable for performance of method. Tracking output key understand where gaps are situated. Additionally, discussions on shortcomings then based facts figures, allowing better partnership between labs. Understanding results learning turn favorable improvement future endeavors.