How will distant assessments be able to complement on-site audits? Please read more here

An analysis of the Warning Letters of Fiscal Year 2021 and of the last 5 years. Please read more here

Stability is defined as the extent to which a product retains, within specified limits, the same properties and characteristics that it possessed at the time of its manufacture and release throughout its period of storage and use (i.e., its shelf-life). Please read more here

QPs are expected to be qualified by education at university degree level and by demonstrating additional defined minimum practical experience. How to they meet these expectations? Please read more here