Tag: iq oq and pq validation

Operator Qualification Success Rate as a Performance Metric

Operator Qualification Success Rate as a Performance Metric Operator Qualification Success Rate as a Performance Metric The validation lifecycle for pharmaceutical processes and equipment is critical to ensure compliance with regulatory expectations set forth by authorities such as the FDA,…

Aligning CPV with ICH Q8, Q9, and Q10 Guidelines

Aligning CPV with ICH Q8, Q9, and Q10 Guidelines Aligning CPV with ICH Q8, Q9, and Q10 Guidelines Pharmaceutical validation is a critical component for ensuring product quality and compliance with regulatory standards. The integration of Continued Process Verification (CPV)…

Troubleshooting Contaminated Media Fill: Root Cause to Report

Troubleshooting Contaminated Media Fill: Root Cause to Report Troubleshooting Contaminated Media Fill: Root Cause to Report In the pharmaceutical industry, ensuring the integrity of aseptic processes is fundamental for delivering safe and effective medications. One critical aspect of this process…

Process vs Equipment Revalidation: Scope and Depth Explained

Process vs Equipment Revalidation: Scope and Depth Explained Process vs Equipment Revalidation: Scope and Depth Explained Revalidation is a critical component of the pharmaceutical manufacturing process that ensures ongoing compliance with regulatory standards. This article provides a comprehensive, step-by-step validation…

Linking Risk Assessment Outputs to Validation Protocols

Linking Risk Assessment Outputs to Validation Protocols Linking Risk Assessment Outputs to Validation Protocols Linking Risk Assessment Outputs to Validation Protocols – Practical guide for pharma professionals on iq oq and pq validation with GMP, FDA and EMA compliance. Step…

Precision Criteria for Stability-Indicating Methods

Precision Criteria for Stability-Indicating Methods Precision Criteria for Stability-Indicating Methods In the pharmaceutical industry, the validation of analytical methods is critical to ensuring safety and efficacy in products. The iq oq and pq validation process is fundamental in establishing the…

HVAC Filter Change and Requalification SOPs

HVAC Filter Change and Requalification SOPs HVAC Filter Change and Requalification SOPs HVAC systems play a critical role in the pharmaceutical industry, ensuring compliance with stringent GMP guidelines and maintaining product integrity. This article serves as a comprehensive, step-by-step tutorial…

Best Practices for Sampling and Testing During Hold Time Studies

Best Practices for Sampling and Testing During Hold Time Studies Best Practices for Sampling and Testing During Hold Time Studies Effective hold time studies are essential for maintaining the quality and integrity of pharmaceutical products throughout the product validation process.…