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  1. MOST RECENT

    1859553

    ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 4 - Process Performance and Product Quality Monitoring System▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2012.

    Languages: English

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  2. MOST RECENT

    1931879524

    GAMP Good Practice Guide: Electronic Data Archiving▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2007.

    Languages: English

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  3. MOST RECENT

    1931879583

    ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2007.

    Languages: English

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  4. HISTORICAL

    1931879540

    ISPE Good Practice Guide: Good Engineering Practice▹

    This document has been replaced. View the most recent version.

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2008.

    Languages: English

    Historical Editions: ISPE Good Practice Guide: Good Engineering Practice, Second Edition

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  5. MOST RECENT

    1633266

    GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version)▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2008.

    Languages: German

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  6. MOST RECENT

    1931879575

    ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2009.

    Languages: English

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  7. HISTORICAL

    1684566

    ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms▹

    This document has been replaced. View the most recent version.

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2009.

    Languages:

    Historical Editions: ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms, ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms

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  8. MOST RECENT

    1931879389

    ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5▹

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2010.

    Languages: English

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  9. HISTORICAL

    1761727

    ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)▹

    This document has been replaced. View the most recent version.

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2010.

    Languages:

    Historical Editions: ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

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  10. HISTORICAL

    1931879001

    ISPE Baseline Guide: Volume 5 - Commissioning and Qualification▹

    This document has been replaced. View the most recent version.

    Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2001.

    Languages:

    Historical Editions: ISPE Baseline Guide: Volume 5 - Commissioning and Qualification, 2nd Edition, ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment

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