HVAC Installed but Still Audit Observations?
Автор: PharmaHealth Insights
Загружено: 2025-12-21
Просмотров: 925
Описание:
#PharmaGMP #AHUvsHVAC #CleanroomHVAC
AHU vs HVAC in Pharma – GMP Explained
Many pharmaceutical facilities invest heavily in HVAC systems, yet still face GMP audit observations.
In this video, we clearly explain the difference between AHU and HVAC from a GMP and regulatory perspective, using real audit insights and practical industry examples.
⏱️ TIMESTAMPS / CHAPTERS
00:00 Introduction – Why AHU vs HVAC Matters in GMP
00:45 HVAC Installed but Still Audit Observations
01:20 What HVAC Really Means in Pharma
02:00 Major HVAC Components Explained
02:42 What an AHU Really Is (GMP Perspective)
03:42 Inside an AHU – Why Each Component Matters
04:03 AHU vs HVAC – Conceptual GMP Difference
04:45 How Auditors View AHUs
05:25 Common Mistake #1 – HVAC Equals GMP?
06:00 Common Mistake #2 – Single AHU for Multiple Areas
06:35 Common Mistake #3 – Comfort-Based Design
07:08 Regulatory Expectations (Schedule M, WHO, EU, US FDA)
07:44 Key AHU Compliance Checkpoints
08:22 Real Audit Insight – Airflow Rationale
09:00 Key Realisation – Air Is a Raw Material
09:30 Final Summary
10:00 Final Question for Pharma Teams
10:30 Closing & Next Session
In this detailed, practical session, we cover:
• The real difference between AHU and HVAC in pharmaceutical manufacturing
• Why auditors focus more on AHUs than on HVAC infrastructure
• How AHU design directly impacts GMP compliance and product quality
• Common mistakes seen during facility design and execution
• What regulators expect as per Schedule M, WHO GMP, EU GMP, and US FDA
• Real audit insights from pharmaceutical facilities
This video is especially useful for:
• QA & Compliance professionals
• Engineering & Projects teams
• Validation & Qualification teams
• Plant Heads & Senior Management
• Pharma students and young professionals
If you are planning:
– A new pharmaceutical manufacturing facility
– Revised Schedule M compliance upgrades
– Capacity expansion or renovation
– Cleanroom or AHU modifications
This video will help you ask the right GMP questions *before* the audit.
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Thank you for watching.
#GMPCompliance #PharmaEngineering #HVACValidation #AHUDesign
#PharmaAudit #ScheduleM #WHO_GMP #CleanroomDesign
#PharmaManufacturing #QualityAssurance #ValidationLifeCycle #pharmatraining
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