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 ...

Stay ahead of the curve with our 2nd edition Analytical Method Validation & Lifecycle Management Masterclass - US Edition. Learn about the latest ICH guidelines, including the new ICH Q14 for ...

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 ...

• Analytical method validation quality standards, touching on MCERTS and ISO 17025 as examples, leading in to an introduction to method accreditation Various case studies are used throughout the ...

Analytical methods and tools play a pivotal role in cleaning validation. Validating the effectiveness of the cleaning of pharmaceutical manufacturing and process equipment is part of good ...