Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...

Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that ...

In the pharmaceutical and biotechnology sector, validation is a mandated practice integral to the entire drug development process, particularly in the context of computerized systems and manufacturing ...

Continued process verification for a cleaning validation program begins once the validation study is complete. Continued process verification (CPV) for a cleaning validation (CV) program begins once ...

SAN FRANCISCO - ValGenesis Inc., a market leader in Enterprise Validation Lifecycle Management Systems (VLMS), today announced that a global pharma giant has gone live with ValGenesis VLMS “ the ...

The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...

The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...

Quality and reliability are essential in pharmaceutical manufacturing. To ensure compliance and high standards are consistently met, the Installation Qualification (IQ), Operational Qualification (OQ) ...

Despite their frequent interchangeable use, understanding the distinction between validation and qualification is critical in pharmaceutical environments. Validation is a broader concept encompassing ...