Clean Rooms & HVAC Systems – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

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Updated on June 3, 2024

Updated on June 3, 2024

USFDA Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice – Guidance
Europe: Annexure 1, Manufacture of Sterile Medicinal Products (EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines)
WHO Good Manufacturing Practices For Sterile Pharmaceutical Products
WHO TRS 1010 – Annex 8: Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products
WHO TRS 1019 – Annex 2: WHO good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products (part 2): interpretation of guidelines
WHO PQT Q&A: Heating, Ventilation and Air-conditioning Systems
PICS: Revised Annex 1 : Manufacture of Sterile Medicinal Products (Guide to Good Manufacturing Practice for Medicinal Products)
ISO 14644-1:2015 – Cleanrooms and associated controlled environments
ISPE: Understanding Cleanliness Classifications for Life Science Facilities
PDA: Understanding ISO 14644-1/2:2015 and Becoming Compliant; Eric Gottlieb; Particle Measuring Systems
VDI 2083: Part 19: Cleanroom technology – Tightness of containments – Classification, planning, and testing

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