True quality assurance is a cultural commitment
"Quality is our watchword, and that is why people come to us. Our quality system is based on GMP practice, and is designed to deliver predominantly clinical trial APIs in accordance with ICHQ7 requirements. However, quality does cost and GMP does require more documentation. That’s why we adopt a “right first time” approach as the core of our quality system. We are a fairly small team so we can maintain a good solid grasp of the overall picture. We also discuss expectations openly to ensure we deliver the necessary level of quality for the best price. Good manufacturing practice is a cultural commitment. We offer a winning mix of Kiwi ingenuity and commitment to the quality assurance that GMP demands.
Documentation: A serious responsibility and a valuable source of progress
Documentation is a huge part of what we do. You often hear people say that GMP also stands for “great mounds of paper.” Our system is designed to carefully manage the large volumes of quality documentation required for IND submission. We have good record management and can find documents at a moment’s notice. Part of my job is to analyze historical documentation to ensure we follow decision-making processes accurately and responsibly. Magic often happens in early-stage development projects where much is still to be validated. We have the expertise to pinpoint those unknowns, the systems to record and manage them, and the experience to incorporate the lessons that documentation can teach us."
Clive Edwards, Quality Manager, GlycoSyn