Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

From small private wells producing around 100 barrels a day to the large bore wells producing more than 40 times that volume, gas and oil and for fuel are produced in nearly every corner of the globe.

The Workshop is planned to highlight, review, and discuss issues related to the implementation of XRF methodologies, including addressing recommendations for compliance to technical requirements of ...

Regulatory, analytical, and process concerns must be taken into account. Process validation (PV) is the collection and evaluation of data from the process design stage through commercial production ...

Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical ...

The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation. The ...