Tag: process validation in pharma

Failure Rate Trends: A Key KPI for Cleaning Validation

Failure Rate Trends: A Key KPI for Cleaning Validation Failure Rate Trends: A Key KPI for Cleaning Validation 1. Understanding User Requirements Specifications (URS) and Risk Assessment The foundation of any effective process validation strategy in pharmaceuticals begins with a…

How to Measure Validation Effectiveness Across Lifecycle Stages

How to Measure Validation Effectiveness Across Lifecycle Stages How to Measure Validation Effectiveness Across Lifecycle Stages In the highly regulated pharmaceutical industry, ensuring the effectiveness of process validation is paramount. The implementation of a meticulous validation lifecycle can serve as…

Audit Checklist for Transport Route Qualification Programs

Audit Checklist for Transport Route Qualification Programs Audit Checklist for Transport Route Qualification Programs In the pharmaceutical industry, ensuring that products are transported according to stringent regulatory standards is vital to maintain quality and compliance. This article provides a comprehensive…

CPV Planning in the Validation Master Plan (VMP)

CPV Planning in the Validation Master Plan (VMP) CPV Planning in the Validation Master Plan (VMP) Continued Process Verification (CPV) is a key component in the lifecycle management of pharmaceutical processes, ensuring that processes remain in a state of control…

Designing Packaging for Products with Narrow Stability Margins

Designing Packaging for Products with Narrow Stability Margins Designing Packaging for Products with Narrow Stability Margins In the highly regulated pharmaceutical industry, ensuring the proper packaging of products with narrow stability margins is critical for maintaining quality and efficacy. This…

How to Design a Media Fill That Simulates Worst-Case Scenarios

How to Design a Media Fill That Simulates Worst-Case Scenarios How to Design a Media Fill That Simulates Worst-Case Scenarios In the pharmaceutical industry, ensuring the sterility of products through robust aseptic processes is crucial. One of the essential components…

Media Fill Protocol Template: Requirements, Volume, Duration

Media Fill Protocol Template: Requirements, Volume, Duration Media Fill Protocol Template: Requirements, Volume, Duration In the field of pharmaceuticals, ensuring the integrity of aseptic processes is crucial for product safety and efficacy. A media fill protocol is an essential component…

SOPs That Must Be in Place for HVAC-Related Activities

SOPs That Must Be in Place for HVAC-Related Activities SOPs That Must Be in Place for HVAC-Related Activities In the pharmaceutical industry, ensuring the integrity of the production environment is critical for both compliance and product quality. The HVAC (Heating,…

Differences Between Requalification and Revalidation

Differences Between Requalification and Revalidation Differences Between Requalification and Revalidation Understanding the distinctions between requalification and revalidation is critical for maintaining compliance with regulatory standards in the pharmaceutical industry. This article outlines a structured approach to process validation in pharma,…