Tag: equipment qualification

How to Perform Flow Rate and Pressure Verification in Utilities

How to Perform Flow Rate and Pressure Verification in Utilities How to Perform Flow Rate and Pressure Verification in Utilities In the pharmaceutical industry, the validation of utility systems such as water, compressed air, and gases is critical for ensuring…

Critical Utilities Qualification: Where to Start

Critical Utilities Qualification: Where to Start Critical Utilities Qualification: Where to Start Critical utilities play an essential role in the pharmaceutical manufacturing process. Understanding how to properly validate these systems is crucial for ensuring compliance with stringent regulatory standards. This…

Compressed Air Equipment Qualification: ISO 8573 Parameters

Compressed Air Equipment Qualification: ISO 8573 Parameters Compressed Air Equipment Qualification: ISO 8573 Parameters In the highly regulated pharmaceutical industry, ensuring the integrity and quality of products is paramount. One critical aspect of this effort is the qualification of compressed…

Steam Generator and Boiler Qualification: A Validation Approach

Steam Generator and Boiler Qualification: A Validation Approach Steam Generator and Boiler Qualification: A Validation Approach In the pharmaceutical industry, ensuring the consistent and safe operation of steam generators and boilers is critical for maintaining product quality and compliance with…

HVAC Equipment Qualification: AHU, Filters, Sensors

HVAC Equipment Qualification: AHU, Filters, Sensors HVAC Equipment Qualification: AHU, Filters, Sensors In the pharmaceutical industry, the validation of HVAC (Heating, Ventilation, and Air Conditioning) systems is crucial for ensuring a controlled environment that meets regulatory and operational standards. This…

Qualification of Water Purification Equipment (RO, WFI, PW)

Qualification of Water Purification Equipment (RO, WFI, PW) Qualification of Water Purification Equipment (RO, WFI, PW) In the pharmaceutical industry, robust equipment qualification is essential to ensure that water purification systems meet stringent regulatory standards. This article provides a step-by-step…

IQOQ for Utility Systems: Compressors, Generators, and Pumps

IQOQ for Utility Systems: Compressors, Generators, and Pumps IQOQ for Utility Systems: Compressors, Generators, and Pumps The validation process in the pharmaceutical industry is critical to ensure that all equipment operates as intended and meets regulatory requirements. This article provides…

Utility System Qualification: What FDA Inspectors Look For

Utility System Qualification: What FDA Inspectors Look For Utility System Qualification: What FDA Inspectors Look For Utility System Qualification is a crucial aspect of pharma validation within the pharmaceutical industry. It ensures that utility systems, which are essential to the…

When to Replace vs Requalify Legacy Systems

When to Replace vs Requalify Legacy Systems When to Replace vs Requalify Legacy Systems In the highly regulated environment of the pharmaceutical industry, ensuring compliance while maintaining operational efficiency is a paramount concern for numerous organizations. Legacy systems, which may…

Legacy Equipment Risk Matrix Template (Downloadable)

Legacy Equipment Risk Matrix Template (Downloadable) Legacy Equipment Risk Matrix Template (Downloadable) In the context of the pharmaceutical validation lifecycle, ensuring the integrity and compliance of legacy equipment is vital for maintaining product quality and regulatory approval. This article provides…