Shared Facilities / Dedicated Facilities requirements – Qvents

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Updated on September 20, 2024

Updated on September 20, 2024

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USFDA Guidance: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross Contamination (Draft Guidance: June 2022)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: Questions And Answers On Implementation Of Risk-Based Prevention Of CrossContamination In Production And ‘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
Schedule M (Page 428): Drugs And Cosmetics Act And Rules, India
ISPE Baseline® Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Second Edition)
Useful Info; The requirements for manufacturing highly active or sensitising drugs comparing Good Manufacturing Practices (Petrelli F, Caraffa A, Scuri S, Grappasonni I, Magrini E, Cocchini A. Acta Biomed. 2019 May 23;
Useful Info: Mitigating Cross-Contamination in Shared Production Facilities Using Risk-Based Cleaning Validation Methods: Considerations and Case Study (USP & USAID)
Useful Info: Prevention of contamination and cross-contamination in medicinal manufacturing facilities; Pharmout White Paper; Novermber 2021.

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