The new industrial revolution, “Industry 4.0,” has been leading to changes in the pharmaceutical industry (“Pharma 4.0”), where significant paradigm shifts have been occurring in the pharmaceutical ...

The key market opportunities lie in providing training for analytical method validation, focusing on drug substance and product analysis. This includes lab procedure transfer techniques, compendial ...

Uniform, globally accepted greenness metrics are positioned as essential; inconsistent scoring frameworks would erode ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

Simple risk assessment. This approach may focus only on the type and complexity of the analytical procedure and its intended use. This approach would enable the establishment of a platform risk ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...