IQ OQ PQ – Pharma Validation

How to Document Route Qualification in a Validation Protocol

How to Document Route Qualification in a Validation Protocol How to Document Route Qualification in a Validation Protocol Validation of transport routes is a critical component in the pharmaceutical supply chain, ensuring that temperature-sensitive products are delivered in compliance with…

Validating Packaging Components for Parenteral Drug Products

Validating Packaging Components for Parenteral Drug Products Validating Packaging Components for Parenteral Drug Products Validating packaging components for parenteral drug products is a critical aspect of pharmaceutical quality assurance. The validation process ensures that these components meet regulatory requirements, are…

Key Differences in HVAC Requirements for Oral vs Injectable Units

Key Differences in HVAC Requirements for Oral vs Injectable Units Key Differences in HVAC Requirements for Oral vs Injectable Units In the pharmaceutical industry, the design and validation of Heating, Ventilation, and Air Conditioning (HVAC) systems are critical for ensuring…

Common Protocol Writing Errors That Trigger Audit Findings

Common Protocol Writing Errors That Trigger Audit Findings Common Protocol Writing Errors That Trigger Audit Findings In today’s rigorous regulatory environment, pharmaceutical and biologics organizations must adhere to stringent guidelines concerning validation documentation. Errors in writing protocols for Installation Qualification…

How to Justify Exclusions and Assumptions in the VMP

How to Justify Exclusions and Assumptions in the VMP How to Justify Exclusions and Assumptions in the VMP The validation lifecycle in the pharmaceutical industry is a complex but rigorous process designed to ensure that products meet predefined specifications. Understanding…

Best Practices for GAMP-Compliant System Implementation

Best Practices for GAMP-Compliant System Implementation Best Practices for GAMP-Compliant System Implementation Implementing a compliant and effective validation framework is crucial in the pharmaceutical and biologics industries. This comprehensive guide outlines the step-by-step process lifecycle for validation as per GAMP…

Writing a Risk-Based IQOQPQ Protocol Template

Writing a Risk-Based IQOQPQ Protocol Template Writing a Risk-Based IQOQPQ Protocol Template Step 1: Understanding User Requirements Specifications (URS) and Risk Assessment In the validation lifecycle of equipment qualification, the process begins with a comprehensive understanding of the User Requirements…

Common Mistakes in Early Stage 1 Process Design and How to Avoid Them

Common Mistakes in Early Stage 1 Process Design and How to Avoid Them Common Mistakes in Early Stage 1 Process Design and How to Avoid Them Effective process validation is a fundamental component of pharmaceutical manufacturing that ensures processes are…

Process Qualification Protocols: Equipment, Utilities & Process Systems

Process Qualification Protocols: Equipment, Utilities & Process Systems Creating Process Qualification Protocols for Equipment, Utilities & Systems in Pharma Stage 2 of pharmaceutical process validation—Process Qualification (PQ)—is the critical phase where designed processes, equipment, and systems are tested under actual…