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 ...

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 ...

Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...

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 ...

QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At the same time, the number of tests run by QC laboratories is ...

In-line UV spectroscopy allows real-time monitoring of cleaning processes, enhancing process control and compliance with Pharma 4.0 goals. The method provides continuous detection of residual cleaning ...