Tag: ppq process performance qualification

Customizable KPI Report Templates for Weekly QA Reviews

Customizable KPI Report Templates for Weekly QA Reviews Customizable KPI Report Templates for Weekly QA Reviews Pharmaceutical quality assurance (QA) and quality control (QC) teams face continuous challenges in maintaining compliance with regulatory expectations and ensuring quality throughout the product…

Data Integrity Risks in Manual vs Automated CPV

Data Integrity Risks in Manual vs Automated CPV Data Integrity Risks in Manual vs Automated CPV In the complex landscape of pharmaceutical validation, the implementation of Continued Process Verification (CPV) is essential to ensure product quality and compliance with regulatory…

Validation Lifecycle Expectations in EU vs US Aseptic Operations

Validation Lifecycle Expectations in EU vs US Aseptic Operations Validation Lifecycle Expectations in EU vs US Aseptic Operations In the highly regulated pharmaceutical industry, particularly in aseptic operations, a thorough understanding of the validation lifecycle is essential. Effective validation not…

How to Use Risk to Justify Delay or Waiver of Revalidation

How to Use Risk to Justify Delay or Waiver of Revalidation How to Use Risk to Justify Delay or Waiver of Revalidation In the pharmaceutical industry, the validation lifecycle plays a critical role in ensuring that processes remain in a…

Audit Trail and Metadata for Risk Assessment Documents

Audit Trail and Metadata for Risk Assessment Documents Audit Trail and Metadata for Risk Assessment Documents In the realm of pharmaceutical validation, maintaining a robust audit trail and effective metadata for risk assessment documents is crucial for ensuring compliance with…

Using Method Validation as Part of NDA/ANDA Submission

Using Method Validation as Part of NDA/ANDA Submission Using Method Validation as Part of NDA/ANDA Submission Validation of processes and methods in pharmaceuticals is critical to ensuring compliance with regulatory requirements and delivering safe and effective products to the market.…

Cleanroom Utility Mapping SOP: Sample Format

Cleanroom Utility Mapping SOP: Sample Format Cleanroom Utility Mapping SOP: Sample Format 1. Understanding User Requirements Specification (URS) and Risk Assessment The User Requirements Specification (URS) is a critical first step in the validation lifecycle. The URS outlines the functional…

Establishing Proven Acceptable Ranges Through Robustness Testing

Establishing Proven Acceptable Ranges Through Robustness Testing Establishing Proven Acceptable Ranges Through Robustness Testing Robustness testing is a critical aspect of process validation in the pharmaceutical industry. It supports the establishment of Proven Acceptable Ranges (PARs) necessary for the process…