Regulatory Guidelines & Common Audit Findings

FDA HVAC Validation Expectations During GMP Audits

FDA HVAC Validation Expectations During GMP Audits FDA HVAC Validation Expectations During GMP Audits As the pharmaceutical industry continues to evolve, regulatory expectations surrounding equipment and system validation have become increasingly stringent. A critical aspect of this is the validation…

EMA Annex 1 and HVAC Design for Aseptic Processing Areas

EMA Annex 1 and HVAC Design for Aseptic Processing Areas EMA Annex 1 and HVAC Design for Aseptic Processing Areas In the pharmaceutical industry, compliance with regulatory requirements is paramount in ensuring the safety and efficacy of medicinal products. One…

WHO HVAC Guidelines for Non-Sterile and Sterile Facilities

WHO HVAC Guidelines for Non-Sterile and Sterile Facilities WHO HVAC Guidelines for Non-Sterile and Sterile Facilities The validation of HVAC systems is critical in maintaining the quality and integrity of pharmaceutical products. This article provides a comprehensive step-by-step guide on…

Common HVAC-Related Observations in 483s and Warning Letters

Common HVAC-Related Observations in 483s and Warning Letters Common HVAC-Related Observations in 483s and Warning Letters In the pharmaceutical industry, ensuring a validated and compliant HVAC system is critical for meeting regulatory standards and ensuring product quality. One of the…

How to Prepare HVAC Validation Documentation for Inspection

How to Prepare HVAC Validation Documentation for Inspection How to Prepare HVAC Validation Documentation for Inspection In the pharmaceutical and medical device industries, HVAC (Heating, Ventilation, and Air Conditioning) validation is a critical aspect of ensuring product quality and compliance…

Linking HVAC Validation with Product Contamination Risk

Linking HVAC Validation with Product Contamination Risk Linking HVAC Validation with Product Contamination Risk In the pharmaceutical and medical device industries, the validation of HVAC (Heating, Ventilation, and Air Conditioning) systems is crucial for ensuring product safety and quality. This…

Regulatory Differences in HVAC Validation: US, EU, WHO, PIC/S

Regulatory Differences in HVAC Validation: US, EU, WHO, PIC/S Regulatory Differences in HVAC Validation: US, EU, WHO, PIC/S Validation processes within the pharmaceutical industry are critical to ensuring compliance with regulatory requirements. HVAC (Heating, Ventilation, and Air Conditioning) systems play…

Responding to Audit Findings Related to HVAC Performance

Responding to Audit Findings Related to HVAC Performance Responding to Audit Findings Related to HVAC Performance Ensuring compliance with regulatory standards in the healthcare and pharmaceutical industry is crucial, particularly in the realm of HVAC (Heating, Ventilation, and Air Conditioning)…

How to Present HVAC Data to Inspectors: Do’s and Don’ts

How to Present HVAC Data to Inspectors: Do’s and Don’ts How to Present HVAC Data to Inspectors: Do’s and Don’ts The validation of HVAC systems is critical in maintaining an appropriate environment for manufacturing and storing pharmaceutical products and medical…

Trending Environmental Data to Satisfy Continued HVAC Validation

Trending Environmental Data to Satisfy Continued HVAC Validation Trending Environmental Data to Satisfy Continued HVAC Validation The pharmaceutical industry operates under stringent regulations to ensure that processes and products maintain high quality and compliance. The validation of HVAC systems is…