Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

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 ...

Approved by the Royal Society of Chemistry for purposes of continuing professional development (CPD). The course will provide you with the requisite scientific knowledge and understanding of ...

DUBLIN, Aug. 28, 2019 /PRNewswire/ -- The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added ...

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 ...

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 ...

Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen. Validation failures, just like out-of-specification (OOS) ...

High-throughput multigene assays interrogating circulating tumor DNA (ctDNA) have the potential to significantly improve the field of precision oncology. However, existing methods are expensive and ...

The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that ...