Tag: Utilities & Support System Validation

Sampling Plan for Pharmaceutical Water Systems: Best Practices

Sampling Plan for Pharmaceutical Water Systems: Best Practices Sampling Plan for Pharmaceutical Water Systems: Best Practices In the production of pharmaceuticals, water systems serve as critical utilities that support various processes, including formulation, cleaning, and equipment rinsing. Therefore, ensuring the…

Conductivity and TOC Testing in Water System Validation

Conductivity and TOC Testing in Water System Validation Conductivity and TOC Testing in Water System Validation Water systems play a crucial role in pharmaceutical manufacturing, where the quality of water directly impacts the safety and efficacy of the final products.…

Microbial Limits and Alert Levels for PW and WFI

Microbial Limits and Alert Levels for PW and WFI Microbial Limits and Alert Levels for PW and WFI As pharmaceutical manufacturing processes increasingly rely on purified water systems, understanding microbial limits and alert levels for Purified Water (PW) and Water…

Validating a Pharmaceutical Water System: RO, PW, WFI

Validating a Pharmaceutical Water System: RO, PW, WFI Validating a Pharmaceutical Water System: RO, PW, WFI Step 1: User Requirements Specification (URS) & Risk Assessment The validation process for a pharmaceutical water system begins with creating a robust User Requirements…

How to Qualify HVAC in Aseptic and Oral Facilities Differently

How to Qualify HVAC in Aseptic and Oral Facilities Differently How to Qualify HVAC in Aseptic and Oral Facilities Differently In the pharmaceutical and biotechnology industries, HVAC systems play a critical role in maintaining the quality and integrity of products.…

HVAC Validation for Grade A/B Cleanrooms: EU GMP Expectations

HVAC Validation for Grade A/B Cleanrooms: EU GMP Expectations HVAC Validation for Grade A/B Cleanrooms: EU GMP Expectations In the highly regulated pharmaceutical environment, validation of HVAC systems for Grade A/B cleanrooms is essential to ensure product quality and compliance…

HVAC Failures in FDA Inspections: Lessons Learned

HVAC Failures in FDA Inspections: Lessons Learned HVAC Failures in FDA Inspections: Lessons Learned The pharmaceutical industry faces strict regulatory standards to ensure product quality and patient safety. Among the critical systems that support manufacturing processes, Heating, Ventilation, and Air…

Using Data Loggers and BMS in HVAC Validation

Using Data Loggers and BMS in HVAC Validation Using Data Loggers and BMS in HVAC Validation In the highly regulated pharmaceutical industry, ensuring the integrity of the environment where products are manufactured is paramount. HVAC (Heating, Ventilation, and Air Conditioning)…

Seasonal Variations in HVAC Performance and Qualification

Seasonal Variations in HVAC Performance and Qualification Seasonal Variations in HVAC Performance and Qualification In the pharmaceutical and biotechnology industries, the integrity of systems such as heating, ventilation, and air conditioning (HVAC) is vital for product quality. The product validation…

HVAC Filter Change and Requalification SOPs

HVAC Filter Change and Requalification SOPs HVAC Filter Change and Requalification SOPs HVAC systems play a critical role in the pharmaceutical industry, ensuring compliance with stringent GMP guidelines and maintaining product integrity. This article serves as a comprehensive, step-by-step tutorial…