Tag: fda system validation

Requalification Frequency for Data Loggers and Sensors

Requalification Frequency for Data Loggers and Sensors Requalification Frequency for Data Loggers and Sensors The validation of data loggers and sensors is a critical component in ensuring compliance with regulatory expectations and quality standards in the pharmaceutical sector. This article…

Case Study: CCI Failure in High-Speed Blister Line

Case Study: CCI Failure in High-Speed Blister Line Case Study: CCI Failure in High-Speed Blister Line This article serves as a comprehensive guide for pharmaceutical professionals engaged in fda system validation, specifically focusing on the validation lifecycle of blister and…

Frequency and Type of Environmental Monitoring Required

Frequency and Type of Environmental Monitoring Required Frequency and Type of Environmental Monitoring Required Environmental monitoring (EM) is an essential component of pharmaceutical manufacturing, particularly in sterile and cleanroom facilities. It ensures that the environment is maintained within defined parameters,…

Traceability Tools and Digital Validation Systems

Traceability Tools and Digital Validation Systems Traceability Tools and Digital Validation Systems In the highly regulated pharmaceutical industry, managing traceability tools and digital validation systems is essential for ensuring compliance with FDA and EMA standards. This comprehensive guide outlines the…

Managing Confidentiality in Multi-Product Validation Plans

Managing Confidentiality in Multi-Product Validation Plans Managing Confidentiality in Multi-Product Validation Plans This article provides a detailed, step-by-step guide for the validation lifecycle, focusing on the intricacies of managing confidentiality in multi-product validation plans. As pharmaceutical companies increasingly operate in…

Electronic Logs and Their Role in Ensuring Data Integrity

Electronic Logs and Their Role in Ensuring Data Integrity Electronic Logs and Their Role in Ensuring Data Integrity In the rapidly evolving pharmaceutical industry, ensuring data integrity is crucial, especially with the increasing reliance on computerized systems. This article will…

Pump and Motor Qualification in Utility Skids

Pump and Motor Qualification in Utility Skids Pump and Motor Qualification in Utility Skids Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The User Requirements Specification (URS) serves as the foundational document for any validation project. In the…

CPV and OOS/OOT Events: Investigation Flow and Records

CPV and OOS/OOT Events: Investigation Flow and Records CPV and OOS/OOT Events: Investigation Flow and Records In the pharmaceutical industry, Continued Process Verification (CPV) and the effective management of Out of Specification (OOS) and Out of Trend (OOT) events are…