Analytical Method development and validation
QACS Labs perform pharmaceutical testing services during and after drug development in order to ensure GMP compliance and product safety. Method validation studies aim to demonstrate analytical suitability of procedures according to their intended use/purpose. QACS transfer method protocols ensure, that results generated by sending and receiving laboratories are equivalent with predetermined acceptance criteria.
Protocols & studies
Method validation aims to demonstrate that a method is suitable for its intended purpose through examination. Procedure validation implies performance or uncertainty evaluation and may involve a number of method characteristics like accuracy, precision, specificity, detection limit, quantitation limit, linearity, range.
Our Labs are GMP compliant to develop, validate and issue analytical methods according to EMA (European Medicines Agency) & ICH guidelines for identifying and quantifying pharmaceutical ingredients. Quality planning guarantees that method validation studies are carried out on optimized and adequately calibrated equipment.
Laboratory data are reviewed by skilled analysts experienced in method validation.
We implement transfer method protocols on already validated methods. QACS Labs are GMP compliant and follow ICH guidelines to ensure that results generated by the sending and the receiving laboratory on identical samples, are equivalent with predetermined acceptance criteria.
The analytical transfer method protocol is carried out by the project coordinator. In turn, the analytical laboratory manager and QA manager review and send the transfer method protocol for approval.
The results obtained during the transfer method study are summarized in a final report.