The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...

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 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 ...

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 ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

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 ...

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

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. The US Pharmacopeial Convention (USP) released a general ...

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 ...