Tag: product validation process

Measuring PQ Effectiveness Using Trending Data

Measuring PQ Effectiveness Using Trending Data Measuring PQ Effectiveness Using Trending Data Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first critical step in the product validation process is to establish a comprehensive User Requirements Specification (URS).…

CPV During Tech Transfer and Site Change

CPV During Tech Transfer and Site Change CPV During Tech Transfer and Site Change This comprehensive guide aims to equip pharmaceutical professionals with a structured approach to Continued Process Verification (CPV) during tech transfer and site changes, ensuring adherence to…

Linking Media Fill to Operator Qualification

Linking Media Fill to Operator Qualification Linking Media Fill to Operator Qualification The validation of aseptic processes is a critical component in the pharmaceutical industry, ensuring that products are manufactured consistently within predetermined specifications and quality attributes. This article presents…

Role of Risk Assessment in Deciding Revalidation Scope

Role of Risk Assessment in Deciding Revalidation Scope Role of Risk Assessment in Deciding Revalidation Scope The validation lifecycle of pharmaceutical products entails a meticulous approach to ensure compliance with regulatory requirements and maintain product quality. One vital aspect is…

Common Mistakes in FMEA Risk Scoring and How to Fix Them

Common Mistakes in FMEA Risk Scoring and How to Fix Them Common Mistakes in FMEA Risk Scoring and How to Fix Them In the pharmaceutical industry, ensuring the quality and safety of products is paramount. This is where the product…

Matrix Effect and Specificity in HPLC and UV Methods

Matrix Effect and Specificity in HPLC and UV Methods Matrix Effect and Specificity in HPLC and UV Methods This article provides a comprehensive, step-by-step tutorial on the product validation process within the context of HPLC and UV analytical methods. The…

Seasonal Variations in HVAC Performance and Qualification

Seasonal Variations in HVAC Performance and Qualification Seasonal Variations in HVAC Performance and Qualification In the pharmaceutical and biotechnology industries, the integrity of systems such as heating, ventilation, and air conditioning (HVAC) is vital for product quality. The product validation…

Statistical Evaluation Methods for Hold Time Study Data

Statistical Evaluation Methods for Hold Time Study Data Statistical Evaluation Methods for Hold Time Study Data The need for stringent product validation processes in the pharmaceutical and biologics industries cannot be overstated. One critical component of this process is the…