Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when applied with digitization, can verify processes in scale-up and technology transfer, and why blend and content uniformity matter for tablet integrity.
iSpeak Blog
Paperless Validation is a current topic of interest within the pharmaceutical industry with many companies now adopting or planning to adopt paperless solutions with the promise of improved data integrity and significant efficiency improvements to their existing paper-based validation processes.
Aseptic process simulation (APS) is essential for validation of an aseptic manufacturing process and is required by regulators to demonstrate the aseptic capability of such processes. A successful program of APS and aseptic manufacturing requires significant operator training, skills, and supervision; thorough maintenance; effective cleaning and disinfection; significant oversight of every...
Across every industry today, digitalization is driving the use and value of data to disrupt traditional business models and ways of working. In pharmaceuticals, the promises of Industry 4.0 are expected, and needed, to finally modernize the legacy approaches that have evolved since the 1970s. Validation is an obvious target for digital disruption because of the inefficient, document-heavy...
Guidance Docs
1 Introduction It is well understood that each clinical trial is conducted and managed as an independent project even if several trials investigate...