The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it can give very good advice when validating laboratory Total Organic ...

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 ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Analytical procedures have increasingly become important when conducting audit on financial statements. This has been shown by the Auditing Standards Board, which made it compulsory to perform ...

The IAEA Environmental Laboratories produce certified reference materials for the measurement of radionuclides, trace elements and organic contaminants. These materials can be used for quality ...

GLP-1 receptor agonists (GLP-1 RAs) are transforming metabolic disease treatment, with analytical chemists playing a critical role in formulation, stability testing, and clinical trial support for ...

The Global Bioprocess Validation Market presents key opportunities driven by the growing demand for biologics and biosimilars, necessitating robust validation. The integration of AI and advanced ...

An analytical review in accounting is used by auditors to assess the reasonableness of account balances. Examples of analytical reviews of financial statements broadly include vertical and horizontal ...