validation of analytical procedures

21 CFR Part 211 and Part 820 Implications on KPI Reporting

21 CFR Part 211 and Part 820 Implications on KPI Reporting 21 CFR Part 211 and Part 820 Implications on KPI Reporting The validation of analytical procedures is a critical component in ensuring the quality and reliability of pharmaceutical products.…

Building Custom CPV Dashboards Using Power BI/Tableau

Building Custom CPV Dashboards Using Power BI/Tableau Building Custom CPV Dashboards Using Power BI/Tableau Continued Process Verification (CPV) has emerged as a critical component in the lifecycle management of pharmaceutical processes, aimed at ensuring ongoing drug quality post-commercialization. This article…

Sterilization-in-Place (SIP) and Clean-in-Place (CIP) in Aseptic Setup

Sterilization-in-Place (SIP) and Clean-in-Place (CIP) in Aseptic Setup Sterilization-in-Place (SIP) and Clean-in-Place (CIP) in Aseptic Setup In the pharmaceutical industry, the validation of analytical procedures is critical to ensuring the quality and safety of aseptic processes. This article provides a…

21 CFR Part 211 Requirements Related to Change Control and Revalidation

21 CFR Part 211 Requirements Related to Change Control and Revalidation 21 CFR Part 211 Requirements Related to Change Control and Revalidation In the pharmaceutical industry, maintaining the quality and integrity of products throughout their lifecycle is paramount. This necessity…

Risk Review and Risk Control Steps as per ICH Q9

Risk Review and Risk Control Steps as per ICH Q9 Risk Review and Risk Control Steps as per ICH Q9 The validation of analytical procedures is a cornerstone within pharmaceutical quality assurance, particularly in relation to risk management based on…

Method Transfer vs Method Validation: Understanding the Differences

Method Transfer vs Method Validation: Understanding the Differences Method Transfer vs Method Validation: Understanding the Differences The validation of analytical procedures is a critical aspect of pharmaceutical development, ensuring the reliability and accuracy of testing methods. This tutorial aims to…

Sampling Techniques for Steam Condensate Analysis

Sampling Techniques for Steam Condensate Analysis Sampling Techniques for Steam Condensate Analysis In the pharmaceutical industry, validating analytical procedures is critical to ensure the accuracy and reliability of results, especially when dealing with utilities like steam systems. This article presents…

How to Validate Powder Blend Homogeneity Effectively

How to Validate Powder Blend Homogeneity Effectively How to Validate Powder Blend Homogeneity Effectively Powder blend homogeneity is a critical aspect in the pharmaceutical manufacturing process, directly influencing the quality and efficacy of the final product. Validating the analytical procedures…