Ideally, process validation should be an extension of the development and refinement processes. To support this, develop a long-term strategy for implementing some of the validation-readiness tools in ...

This directive aligns Process Validation activities with a product life cycle concept and with existing FDA and EU guidance, including the FDA/International Conference on Harmonization (ICH ...

Five phases guide the new product development process for small businesses: idea generation, screening, concept development, product development and, finally, commercialization.

The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the ...

Process Validation Guidance Requirements: ... The lifecycle concept, new to these Guidances, link product and process development, ...

This directive aligns Process Validation activities with a product life cycle concept and with existing FDA and EU guidance, including the FDA/International Conference on Harmonization (ICH), Guidance ...

SANTA CLARA, Calif., June 04, 2025--ValGenesis, Inc., the global innovator in digital validation lifecycle management, today announced the launch of ValGenesis Smart GxP™, the first AI-enabled ...

The scale development process begins with item generation, followed by five studies: (1) scale purification and initial validation, (2) exploration of the nomological network, (3) tests for the ...

ValGenesis Launches Smart GxP™ as First AI-Enabled Platform to Unify Validation and Process Development. ValGenesis, Inc., the global innovator in digital validation lifecycle management, today ...