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ISPE Good Practice Guide: Maintenance (Second Edition) Good …

WebThis Guide is focused on maintenance in GMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program. …

Actived: 1 days ago

URL: https://guidance-docs.ispe.org/doi/book/10.1002/9781946964380

ISPE Good Practice Guide: Assessing the Particulate Containment

WebThe ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition) has been updated to address a broader …

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ISPE Good Practice Guide: Cold Chain Management Good …

WebThis Guide provides tools and strategies for Cold Chain Management and to complement work by the Guidance for Temperature Controlled Medicinal Products. It helps to …

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ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP …

WebMaintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their …

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ISPE Good Practice Guide: Investigational Medicinal Product …

WebEvery year the number of clinical trials conducted across the globe rises in a concerted effort to develop new or improved medicinal products that ultimately improve lives.

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ISPE Baseline® Guide: Volume 1 – Active Pharmaceutical …

WebThis revised Guide builds on the original principles of ISPE’s Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, (originally entitled Bulk Pharmaceutical Chemicals).

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ISPE Good Practice Guide: Membrane-Based Water for Injection …

WebThe ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and quality aspects of …

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ISPE Guide: Biopharmaceutical Process Development and …

WebThis Guide is intended to be used in the design, development, implementation, operation, quality control, and quality assurance of biopharmaceutical processes. This guidance …

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The Cultural Excellence Report

WebPreface. The Quality Excellence Report shares insights on quality culture improvement across six key dimensions and outlines a series of practical and powerful approaches, …

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ISPE GAMP® Good Practice Guide: A Risk-Based Approach to …

WebThe use of mobile platforms – including smartphones, tablets, and wearable devices – by the general public has increased hugely. In 2013, sales of smartphones exceeded the …

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ISPE Guidance Docs

WebISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment, International Society for Pharmaceutical …

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ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, …

WebThis ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls provides a hands-on approach to support the life science industry in the development …

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ISPE Readiness Report Bundle Initiatives

WebISPE Readiness Report Bundle. Report on ISPE Work to Support Establishment of the European Union Health Emergency Preparedness and Response Authority (HERA) …

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ISPE Guidance Docs

WebPIC/S Guide: PE 011-1 Good Distribution Practice for Medicinal Products, Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme …

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ISPE Baseline® Guide: Volume 7 – Risk-Based Manufacture of

WebThe ISPE Baseline ® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition provides a scientific risk-based approach, based on ICH Q9 …

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ISPE Guidance Docs

WebISPE Baseline® Pharmaceutical Engineering Guide, Volume 7 – Risk-Based Manufacture of Pharmaceutical Products, International Society for Pharmaceutical Engineering (ISPE), …

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ISPE Guide: Advanced Therapy Medicinal Products – Recombinant …

WebAs gene therapy products race towards the clinic and commercial launch, sponsor companies are faced with significant hurdles posed by evolving manufacturing platforms, …

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ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical …

WebThe ISPE GAMP ® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management provides information to support the adoption of new and improved …

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2023 ISPE Drug Shortages Prevention Model Initiatives

WebThe ISPE Drug Shortages Prevention Model serves as a guide to help prevent drug shortages by providing quality, regulatory, and technical recommendations for the …

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