Shared Facilities / Dedicated Facilities requirements – Qvents

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Updated on October 11, 2023

Updated on October 11, 2023

USFDA 21 CFR 211.42: Design and construction features.(Pencillins require dedicated facilities)
USFDA Guidance: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross Contamination (Draft Guidance: June 2022)
ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: D. Containment (4.4)
EMA: Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities – Scientific guideline
Europe (EC GMP Guide): Manufacture Of Veterinary Medicinal Products Other Than Immunological Veterinary Medicinal Products
WHO TRS 957 – Annex 3: WHO good manufacturing practices for pharmaceutical products containing hazardous substances
Also read: WHO Guideline To The Inspection Of Hormone Product Manufacturing Facilities (Working document QAS/08.256 February 2008 RESTRICTED) & ISPE Comments
PICS: Guideline On Setting Health Based Exposure Limits For Use In Risk Identification In The Manufacture Of Different Medicinal Products In Shared Facilities
PICS: Cross-Contamination In Shared Facilities

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