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  1. MOST RECENT

    ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition)▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2024.

    Languages: English

    Historical Editions: ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice)

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  2. MOST RECENT

    ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2024.

    Languages: English

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  3. MOST RECENT

    ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good Practices for Pharmacies▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/01/2024.

    Languages: English

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  4. MOST RECENT

    ISPE Guide: ATMPs - Allogeneic Cell Therapy▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2024.

    Languages: English

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  5. MOST RECENT

    ISPE Guide: ATMPs - Recombinant AAV Comparability and Lifecycle Management▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2024.

    Languages: English

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  6. MOST RECENT

    ISPE Baseline Guide: Volume 8: Pharma 4.0, 1st Edition▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2023.

    Languages: English

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  7. MOST RECENT

    ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2023.

    Languages: English

    Historical Editions: ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities, ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities

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  8. MOST RECENT

    ISPE Good Practice Guide: Process Gases, Second Edition▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/01/2023.

    Languages: English

    Historical Editions: ISPE Good Practice Guide: Process Gases

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  9. MOST RECENT

    ISPE Guide: 503B Compounding▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2023.

    Languages: English

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  10. MOST RECENT

    ISPE Readiness Report Bundle▹

    Report on ISPE Work to Support Establishment of the European Union Health Emergency Preparedness and Response Authority (HERA) and Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2023.

    Languages: English

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