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PDA TR 85
Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers
Report / Survey by Parenteral Drug Association, 2021.
Languages: English
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Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)
Report / Survey by Parenteral Drug Association, 2020.
Languages: English
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Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration
Report / Survey by Parenteral Drug Association, 2020.
Languages: English
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Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators
Report / Survey by Parenteral Drug Association, 2020.
Languages: English
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Points to Consider for Sensitivity to Oxidation by Peroxide
Report / Survey by Parenteral Drug Association, 2020.
Languages: English
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PDA TR 84
Technical Report No. 84 (TR 84) Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Report / Survey by Parenteral Drug Association, 2020.
Languages: English
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PDA TR 54-6
Technical Report No. 54-6 (TR 54-6) Formalized Risk Assessment for Excipients
Report / Survey by Parenteral Drug Association, 12/01/2019.
Languages: English
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PDA TR 82
Technical Report No. 82 (TR 82) Low Endotoxin Recovery
Report / Survey by Parenteral Drug Association, 2019.
Languages: English
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PDA TR 81
Technical Report No. 81 (TR 81) Cell-Based Therapy Control Strategy
Report / Survey by Parenteral Drug Association, 2019.
Languages: English
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PDA TR 83
Technical Report No. 83 (TR 83) Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response
Report / Survey by Parenteral Drug Association, 2019.
Languages: English
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