White Papers | ISPE | International Society for Pharmaceutical Engineering

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field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/digital-validation-use-cases-challenges-standards-and-regulatory" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2025-02/standard-quality-control-collage-concept-750px.jpg?itok=-NehJOyY" width="1000" height="600" alt="standard-quality-control-collage-concept" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/digital-validation-use-cases-challenges-standards-and-regulatory" hreflang="en">Digital Validation – Use Cases, Challenges, Standards, and Regulatory Guidance</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2025-02-10T15:23:19Z">10 February 2025</time> </div> <div class="tex2jax_process"><p>Currently, there is no single guidance document providing a comprehensive roadmap for executing digital validation. While elements from ISPE GAMP® Guides Series and the ISPE Baseline® Guide: Volume 8 – Pharma 4.0™, apply to digital validation, there is no consolidated resource addressing common questions. The authors of this Concept Paper therefore advocate for the development of a Good...</p></div> </div> </div> </article> </div> <div class="column column-block"> <article id="node-280622" data-history-node-id="280622" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/pharma-40-plug-produce-architectural-principles" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-12/technological-blue-background-circuit_.jpg?itok=kV_HSlKY" width="1000" height="600" alt="technological-blue-background" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/pharma-40-plug-produce-architectural-principles" hreflang="en">Pharma 4.0 – Plug & Produce Architectural Principles</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-12-05T19:17:49Z">5 December 2024</time> </div> <div class="tex2jax_process"><p>A set of principles to be considered in the journey to adopting and deploying an architecture capable of supporting Pharma 4.0 Plug & Produce capability.</p></div> </div> </div> </article> </div> <div class="column column-block"> <article id="node-272679" data-history-node-id="272679" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/pharma-40-towards-itot-architectures-prescriptive-maintenance" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/digitization-Image%20by%20Gerd%20Altmann%20from%20Pixabay.jpg?itok=axg9ryHE" width="1000" height="600" alt="digitization-Image by Gerd Altmann from Pixabay" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/pharma-40-towards-itot-architectures-prescriptive-maintenance" hreflang="en">Pharma 4.0 – Towards IT/OT Architectures for Prescriptive Maintenance</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-03-01T18:48:52Z">1 March 2024</time> </div> <div class="tex2jax_process"><p>Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are urged to increase production efficiency by making better use of time and resources. This is in addition to addressing the unique challenges faced by pharmaceutical manufacturers such as a strictly regulated environment, heterogeneous equipment suppliers, and long adaptation times....</p></div> </div> </div> </article> </div> </div> <div class="row medium-up-2 large-up-3"> <div class="column column-block"> <article id="node-272572" data-history-node-id="272572" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/process-events-life-science-industry-information-model-concept-opc-ua" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/technology-Image%20by%20Tung%20Nguyen%20from%20Pixabay.jpg?itok=l3NBjjJI" width="1000" height="600" alt="technology-Image by Tung Nguyen from Pixabay" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/process-events-life-science-industry-information-model-concept-opc-ua" hreflang="en">Process Events for the Life Science Industry - Information Model Concept on OPC UA for Alarms and Audit Trails</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-02-01T19:27:46Z">1 February 2024</time> </div> <div class="tex2jax_process"><p>This Concept Paper proves that a standard model within OPC UA Alarms and Conditions (OPC UA Part 9) can be leveraged to realize Plug & Produce for exchanging pharmaceutical alarms and audit trails between OT manufacturing equipment and Orchestration Platforms or IT Services like EBR or Historian.</p></div> </div> </div> </article> </div> <div class="column column-block"> <article id="node-272571" data-history-node-id="272571" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/simplified-integration-qualified-laboratory-devices-asset-administration" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/microscope-Image%20by%20Gerd%20Altmann%20from%20Pixabay.jpg?itok=_tM8Letv" width="1000" height="600" alt="microscope-Image by Gerd Altmann from Pixabay" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/simplified-integration-qualified-laboratory-devices-asset-administration" hreflang="en">A Simplified Integration of Qualified Laboratory Devices with the Asset Administration Shell as the Digital Twin</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2023-05-01T18:38:12Z">1 May 2023</time> </div> <div class="tex2jax_process"><p>This Concept Paper proves a laboratory device integration utilizing the Asset Administration Shell (AAS) metamodel (agnostic to the underlying technology and data structure).</p></div> </div> </div> </article> </div> <div class="column column-block"> <article id="node-272696" data-history-node-id="272696" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/bio-fluorescent-particle-counter-bfpc-continuous-environmental-viable" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/ai-generated-8797312_1920.jpg?itok=Gibqgxb1" width="1000" height="600" alt="ai-generated-8797312_1920" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/bio-fluorescent-particle-counter-bfpc-continuous-environmental-viable" hreflang="en">Bio-Fluorescent Particle Counter (BFPC) Continuous Environmental Viable Particle Monitoring Strategy for Aseptic Filling</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2023-02-28T15:57:14Z">28 February 2023</time> </div> <div class="tex2jax_process"><p>The adoption of Environmental Monitoring (EM) through modern technologies, such as BFPCs, has proven to be a long process and requires a solid data set and validation strategy to be accepted by the authorities. This paper provides key points to consider during the implementation of BFPCs as a routine EM tool in modern isolators.</p></div> </div> </div> </article> </div> </div> <div class="row medium-up-2 large-up-3"> <div class="column column-block"> <article id="node-272697" data-history-node-id="272697" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/connectivity-between-shopfloor-manufacturing-operations-management" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/pexels-tara-winstead-AI.jpg?itok=QcMw8gEa" width="1000" height="600" alt="pexels-tara-winstead-AI." /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/connectivity-between-shopfloor-manufacturing-operations-management" hreflang="en">Connectivity between Shopfloor & Manufacturing Operations Management Systems with OPC UA – A Tangible Step Toward Plug & Produce</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2021-04-01T11:22:50Z">1 April 2021</time> </div> <div class="tex2jax_process"><p>This Concept Paper presents a solution for standardizing one aspect of Plug & Produce, namely the transactional interaction between ISA95 Level 2 (L2) and Level 3 (L3). This solution introduces an OPC UA meta model that allows for the construction and implementation of a service-based transactional interaction. The authors believe that this approach has the potential to reduce project...</p></div> </div> </div> </article> </div> <div class="column column-block"> <article id="node-273138" data-history-node-id="273138" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/unique-identification-primary-containers-drive-product-traceability" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/Mastering%20Controlled%20Temperature%20Chambers-750px.jpg?itok=Ql45JGO7" width="1000" height="600" alt="Mastering Controlled Temperature Chambers-750px.jpg" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/unique-identification-primary-containers-drive-product-traceability" hreflang="en">Unique Identification on Primary Containers to Drive Product Traceability & Quality</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2021-02-01T18:32:56Z">1 February 2021</time> </div> <div class="tex2jax_process"><p>The purpose of this document is to obtain feedback from practitioners on the issues and challenges that may be faced if and when uniquely identified primary containers for parenteral products are implemented within their manufacturing operations.</p></div> </div> </div> </article> </div> <div class="column column-block"> <article id="node-273154" data-history-node-id="273154" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/process-validation-lifecycle-packaging-oral-solid-dosage-forms" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/Portable-manufacturing-750px.jpg?itok=NBGOUYUu" width="1000" height="600" alt="Portable-manufacturing-750px.jpg (254.19 KB) " /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/process-validation-lifecycle-packaging-oral-solid-dosage-forms" hreflang="en">Process Validation Lifecycle for Packaging Oral Solid Dosage Forms</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2020-02-21T18:51:22Z">21 February 2020</time> </div> <div class="tex2jax_process"><p>The ISPE Discussion Paper “Overview of Packaging Validation for Drug Products” explores the different ways to implement packaging validation; however, it does not provide specific guidance on OSD forms packaging. This paper aims to address this gap using concepts based on the 2011 FDA Guidance, Process Validation: General Principles and Practices. Covering Stages 2.2 and 3, this paper...</p></div> </div> </div> </article> </div> </div> </div> <nav class="pager" role="navigation" aria-labelledby="pagination-heading"> <h4 id="pagination-heading" class="visually-hidden">Pagination</h4> <ul class="pagination pager__items js-pager__items"> <li class="pager__item is-active current"> <a href="?page=0" title="Current page" rel="nofollow" aria-current="page"> <span class="visually-hidden"> Current page </span>1</a> </li> <li class="pager__item"> <a href="?page=1" title="Go to page 2" rel="nofollow" > <span class="visually-hidden"> Page </span>2</a> </li> <li class="pager__item"> <a href="?page=2" title="Go to page 3" rel="nofollow" > <span class="visually-hidden"> Page </span>3</a> </li> <li class="pager__item"> <a href="?page=3" title="Go to page 4" rel="nofollow" > <span class="visually-hidden"> Page </span>4</a> </li> <li class="pager__item pager__item--next arrow"> <a href="?page=1" title="Go to next page" rel="next"> <span 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