iq pq and oq – Pharma Validation

Role of GPS and Environmental Sensors in Route Validation

Role of GPS and Environmental Sensors in Route Validation Role of GPS and Environmental Sensors in Route Validation In the highly regulated pharmaceutical landscape, ensuring the integrity and quality of products during transport is paramount. The validation of transport routes,…

Common Deficiencies in Primary Packaging Validation Cited by FDA

Common Deficiencies in Primary Packaging Validation Cited by FDA Common Deficiencies in Primary Packaging Validation Cited by FDA Primary packaging validation is a critical component within the pharmaceutical industry that ensures the safety, efficacy, and integrity of drug products. This…

How to Select Filters: HEPA, ULPA, and Pre-Filters for HVAC

How to Select Filters: HEPA, ULPA, and Pre-Filters for HVAC How to Select Filters: HEPA, ULPA, and Pre-Filters for HVAC Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The foundation of any validation lifecycle begins with a clear…

Requalification Protocol Writing Based on Change Impact

Requalification Protocol Writing Based on Change Impact Requalification Protocol Writing Based on Change Impact In the pharmaceutical industry, maintaining compliance with stringent regulatory standards is paramount. A critical component of this compliance is the validation process. This comprehensive tutorial focuses…

VMP Review Frequency: When and How Often to Update

VMP Review Frequency: When and How Often to Update VMP Review Frequency: When and How Often to Update The Validation Master Plan (VMP) is a critical document that outlines the validation strategy for pharmaceutical processes, making it essential for ensuring…

Challenges in Implementing GAMP 5: Real-World Case Studies

Challenges in Implementing GAMP 5: Real-World Case Studies Challenges in Implementing GAMP 5: Real-World Case Studies In the rapidly evolving landscape of pharmaceutical manufacturing, adherence to Good Automated Manufacturing Practice (GAMP 5) while ensuring compliance with regulations like FDA and…

QA Review Checklist for IQOQ Documentation

QA Review Checklist for IQOQ Documentation QA Review Checklist for IQOQ Documentation In the pharmaceutical industry, the validation of equipment and processes is critical to ensure product quality, consistency, and regulatory compliance. This step-by-step tutorial provides a comprehensive roadmap for…

How to Document Stage 1 Validation Activities for Audit Readiness

How to Document Stage 1 Validation Activities for Audit Readiness How to Document Stage 1 Validation Activities for Audit Readiness In pharmaceutical validation, especially for process design, stringent regulatory requirements necessitate a methodical approach to ensure product quality and compliance.…