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  1. 2122591

    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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  2. 2504474

    PDA PTC PUPSIT 2▹

    Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)

    Report / Survey by Parenteral Drug Association, 03/01/2020.

    Languages: English

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  3. 2504472

    PDA PTC PUPSIT 1▹

    Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration

    Report / Survey by Parenteral Drug Association, 02/01/2020.

    Languages: English

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  4. 2504475

    PDA ▹

    Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators

    Report / Survey by Parenteral Drug Association, 01/01/2020.

    Languages: English

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  5. 2188601

    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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  6. 2191831

    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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  7. 2188171

    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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  8. 2188172

    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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  9. 2085949

    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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  10. 2030656

    PDA TR 80▹

    Technical Report No. 80 (TR 80) Data Integrity Management System for Pharmaceutical Laboratories

    Report / Survey by Parenteral Drug Association, 08/01/2018.

    Languages: English

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