Tag: pq qualification

Using GAMP5 Principles to Validate KPI Tracking Software

Using GAMP5 Principles to Validate KPI Tracking Software Using GAMP5 Principles to Validate KPI Tracking Software Step 1: Understanding User Requirements Specifications (URS) and Risk Assessment In the lifecycle of software validation, the first critical step is defining the User…

SOPs Required to Support CPV Programs

SOPs Required to Support CPV Programs SOPs Required to Support CPV Programs Step 1: Understanding the Regulatory Landscape In the realm of pharmaceutical manufacturing, compliance with regulatory guidelines is paramount for ensuring product quality and safety. The foundation of any…

Audit-Ready Documentation Flow for Aseptic Validation

Audit-Ready Documentation Flow for Aseptic Validation Audit-Ready Documentation Flow for Aseptic Validation Step 1: User Requirements Specification (URS) and Risk Assessment The foundation of any validation effort is the User Requirements Specification (URS). The URS outlines the specific requirements that…

Case Study: Risk-Based Revalidation Saves Time and Cost

Case Study: Risk-Based Revalidation Saves Time and Cost Case Study: Risk-Based Revalidation Saves Time and Cost Step 1: Understanding Process Design and User Requirements Specification (URS) Process validation is a lifecycle that ensures processes consistently produce products that meet predetermined…

Risk Lifecycle Maps in Digital Validation Systems

Risk Lifecycle Maps in Digital Validation Systems Risk Lifecycle Maps in Digital Validation Systems The validation lifecycle in a pharmaceutical environment is a complex process that integrates various stages, each critical to ensuring product quality and compliance with regulatory standards.…

Bridging Studies Between Old and New Validated Methods

Bridging Studies Between Old and New Validated Methods Bridging Studies Between Old and New Validated Methods This article provides a comprehensive, step-by-step guide for pharmaceutical professionals on process performance qualification (PPQ) as part of the pq qualification lifecycle. It aligns…

Loop Integrity Testing Using Dye or Pressure Hold

Loop Integrity Testing Using Dye or Pressure Hold Loop Integrity Testing Using Dye or Pressure Hold This comprehensive guide serves as a step-by-step tutorial for pharmaceutical professionals on the process qualification (PQ) relating to loop integrity testing using dye or…

Inter- and Intra-batch Variability: A Risk to Process Robustness

Inter- and Intra-batch Variability: A Risk to Process Robustness Inter- and Intra-batch Variability: A Risk to Process Robustness Ensuring robust pharmaceutical processes is paramount for maintaining product quality and meeting regulatory standards. The presence of inter- and intra-batch variability poses…