Tag: iq oq pq format

EMA and WHO Focus Areas During Validation Metric Audits

EMA and WHO Focus Areas During Validation Metric Audits EMA and WHO Focus Areas During Validation Metric Audits Validation metrics and key performance indicators (KPIs) are crucial in the pharmaceutical industry to ensure compliance with regulatory requirements, particularly during validation…

How to Implement CPV Automation in GMP Environments

How to Implement CPV Automation in GMP Environments How to Implement CPV Automation in GMP Environments In the highly regulated pharmaceutical industry, Continued Process Verification (CPV) has emerged as a critical component of the Quality by Design (QbD) paradigm, as…

Facility Design Qualification: Cleanroom Classification and HVAC Validation

Facility Design Qualification: Cleanroom Classification and HVAC Validation Facility Design Qualification: Cleanroom Classification and HVAC Validation In the pharmaceutical and biologics industry, ensuring the integrity and quality of products is paramount. A significant aspect of this integrity comes from well-designed…

Regulatory Differences in Revalidation for Equipment vs Processes

Regulatory Differences in Revalidation for Equipment vs Processes Regulatory Differences in Revalidation for Equipment vs Processes In the pharmaceutical industry, ensuring compliance with regulatory requirements is essential for maintaining product quality, safety, and efficacy. An integral component of this compliance…

How to Implement ICH Q9 in Validation Activities

How to Implement ICH Q9 in Validation Activities How to Implement ICH Q9 in Validation Activities The implementation of ICH Q9 principles within the validation lifecycle is essential for ensuring that pharmaceutical products are produced to meet quality standards consistently.…

USP and EP Criteria for System Suitability Parameters

USP and EP Criteria for System Suitability Parameters USP and EP Criteria for System Suitability Parameters This article serves as a comprehensive tutorial on the validation process for analytical methods, focusing primarily on the criteria for system suitability parameters according…

Steam Quality Tests: Non-condensable Gases, Superheat, Dryness

Steam Quality Tests: Non-condensable Gases, Superheat, Dryness Steam Quality Tests: Non-condensable Gases, Superheat, Dryness In the pharmaceutical industry, the validation of steam systems is crucial for ensuring safe and efficient sterilization processes. This article will present a step-by-step tutorial on…

Process Capability Case Studies in OSD and Sterile Manufacturing

Process Capability Case Studies in OSD and Sterile Manufacturing Process Capability Case Studies in OSD and Sterile Manufacturing Step 1: Define User Requirements and Conduct Risk Assessment The first step in the validation lifecycle is to establish the User Requirements…