We conduct method validation studies to demonstrate that a method is suitable for its intended purpose. We also implement transfer method protocols to ensure that the results generated by sending and receiving laboratories are equivalent within predetermined acceptance criteria.
Our method validation studies
We develop, validate and issue analytical methods according to the European Medicines Agency (EMA) and International Conference on Harmonisation (ICH) guidelines for identifying and quantifying pharmaceutical ingredients.
Method validation aims to demonstrate that a method is suitable for its intended purpose, through examination. It implies performance and uncertainty evaluation.
Our quality planning guarantees that method validation studies are carried out on optimised and adequately calibrated equipment.
Our skilled analysts are competent in method validation, and have adequate knowledge and experience to observe and assess data during method validation.
Our transfer method protocols
We implement transfer method protocols on already validated methods. This ensures that the results generated by the sending and the receiving laboratory on identical samples are equivalent within predetermined acceptance criteria.
Our project coordinator composes the analytical transfer method protocol. In turn, our laboratory manager and QA manager review and send the transfer method protocol for approval.
The results obtained during the transfer method study are summarised in a final report.
Have a question? We can help find an answer
Fill in our contact form below to request our price list and find out how our QACS Laboratory team can help you.