The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...

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 ...

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 ...

Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

Since the introduction of Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP OES) in 1974, and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) in 1980, these techniques have ...

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 ...

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...

In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...