HVAC Qualification Protocols (IQ/OQ/PQ)

Installation Qualification (IQ) Checklist for HVAC Equipment

Installation Qualification (IQ) Checklist for HVAC Equipment Installation Qualification (IQ) Checklist for HVAC Equipment The Installation Qualification (IQ) phase is a critical component of the validation lifecycle in the pharmaceutical and medical device industries. This detailed validation tutorial aims to…

Operational Qualification Tests: AHU Functionality and Alarm Verification

Operational Qualification Tests: AHU Functionality and Alarm Verification Operational Qualification Tests: AHU Functionality and Alarm Verification Step 1: Understanding User Requirements Specifications (URS) and Risk Assessment The foundation of any validation effort lies within the User Requirements Specification (URS) and…

Performance Qualification (PQ): Cleanroom Recovery, Velocity, and Monitoring

Performance Qualification (PQ): Cleanroom Recovery, Velocity, and Monitoring Performance Qualification (PQ): Cleanroom Recovery, Velocity, and Monitoring Cleaning validation is a critical component of compliant operations in the pharmaceutical and medical device sectors. To ensure that these environments meet regulatory expectations,…

Preparing HVAC Qualification Protocols: Template and Key Sections

Preparing HVAC Qualification Protocols: Template and Key Sections Preparing HVAC Qualification Protocols: Template and Key Sections Step 1: Understanding User Requirements Specifications (URS) and Risk Assessment In the pharmaceutical industry, HVAC systems are critical for maintaining the necessary environmental conditions…

Acceptance Criteria for Air Change Rate, Temperature, and RH

Acceptance Criteria for Air Change Rate, Temperature, and RH Acceptance Criteria for Air Change Rate, Temperature, and RH: A Step-by-Step Validation Tutorial Validation in the pharmaceutical industry is a stringent process that ensures all systems operate within defined parameters to…

Balancing and Commissioning as Pre-requisite to Qualification

Balancing and Commissioning as Pre-requisite to Qualification Balancing and Commissioning as Pre-requisite to Qualification In the pharmaceutical industry, maintaining stringent quality assurance measures is pivotal. One of the crucial elements of quality assurance is the validation process. Validation in pharmaceutics…

Mapping HVAC Components to URS and DQ Requirements

Mapping HVAC Components to URS and DQ Requirements Mapping HVAC Components to URS and DQ Requirements In the pharmaceutical industry, validation plays a crucial role in ensuring that processes and systems operate within defined limits to produce high-quality products consistently.…

How to Perform Filter Integrity (Leak) Tests for PQ

How to Perform Filter Integrity (Leak) Tests for PQ How to Perform Filter Integrity (Leak) Tests for PQ In the pharmaceutical industry, maintaining product quality and ensuring compliance with regulatory standards is critical. Filter integrity testing is an essential aspect…

Testing Differential Pressure, Velocity, and Clean-Up Time

Testing Differential Pressure, Velocity, and Clean-Up Time Testing Differential Pressure, Velocity, and Clean-Up Time The validation in pharma company is essential to ensure compliance with regulatory requirements while maintaining product quality and patient safety. This article provides a step-by-step tutorial…