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Shared Facilities / Dedicated Facilities requirements
Qvents
2 minutes read
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Home
Guidelines
Shared Facilities / Dedicated Facilities requirements
Updated on September 20, 2024
Home
Guidelines
Shared Facilities / Dedicated Facilities requirements
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Draft Guidance: June 2022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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