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Guidance Documents

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  • Baseline Guide Vol 4: Water & Steam Systems 3rd Edition

    Baseline Guide Vol 4: Water & Steam Systems 3rd Edition

    Published
    The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance.
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  • Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

    Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

    Published
    The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.
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  • GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

    GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

    Published
    The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them.
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  • Good Practice Guide: Process Validation

    Good Practice Guide: Process Validation

    Published
    The shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices. The science and risk-based approach combines product development knowledge with a structured process performance and product quality monitoring system to provide for validation throughout the product lifecycle.
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Cell and Gene Therapies & Their GMP Requirements

Pharmaceutical Engineering Magazine
Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they...
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November / December 2019

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