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FDA 483 - Table View
WHO TRS
EU GMP
PMDA GMP
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FDA 483 Observations related to Microbiology
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Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Container closure systems do not provide adequate protection against foreseeable external factors
30/06/2024
Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process
30/06/2024
Microbiology FDA 483 (Jubilant Radiopharmacies): The movement of first air in the ISO 5 area is blocked or disrupted
27/05/2024
Microbiology FDA 483 (Jubilant Radiopharmacies): Personnel were observed performing aseptic processing outside of an ISO 5 area
27/05/2024
Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
22/05/2024
Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions
22/05/2024
Microbiology FDA 483 Observations : Searchable Table
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WHO Guidelines
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WHO TRS 908 : Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
WHO TRS 1033 : Annex 3 Good Manufacturing Practices: Water for Pharmaceutical use
WHO TRS 961 : Annex 2 WHO Good Practices for Pharmaceutical Microbiology Laboratories
WHO TRS 1019 : Annex 2 Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products (Part2)
WHO TRS 1010 : Annex 8 Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products (Part1)
US FDA Guidelines & CFR
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FDA : Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
FDA : Microbiological Quality Considerations in Non-sterile Drug Manufacturing Guidance for Industry (Draft)
EU GMP Guidelines
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EU GMP Guideline on the Quality of Water for Pharmaceutical use
EU GMP Annex 1: Manufacture of Sterile Medicinal Products (2022, Final)
PMDA GMP Guidelines
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PMDA : Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing
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