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ISPE Regulatory Operations | ISPE | International Society for Pharmaceutical Engineering
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height="400" alt="Regulatory" /> </picture> </div> </section> </div> </div> </div> <div class="l-help row"> <div class="large-12 columns"> </div> </div> <div class="row"> <main id="main" class="medium-8 columns main" role="main"> <a id="main-content"></a> <section class="p-t-1 p-b-1"> <div class="region--content region"> <section id="block-ispe-breadcrumbs" class="block-ispe-breadcrumbs block block-system block-system-breadcrumb-block"> <div class="use-tailwind"> <nav role="navigation" aria-labelledby="system-breadcrumb" class="max-w-content-limit-with-padding-compensation mx-auto mt-6 md:mt-8 mb-4 px-6 xl:px-0"> <h2 id="system-breadcrumb" class="visually-hidden">You are here</h2> <ul class="breadcrumbs"> <li> <a href="/">Home</a> </li> <li> <a href="/initiatives/regulatory">ISPE Regulatory Operations</a> </li> <li class="current"><a href="#">ISPE Regulatory Operations</a></li> </ul> </nav> </div> </section> <section id="block-pagetitle" class="ispe_page_title block-pagetitle block block-core block-page-title-block"> <h1><span>ISPE Regulatory Operations</span> </h1> </section> <section id="block-ispe-content" class="block-ispe-content block block-system block-system-main-block"> <article id="node-573" data-history-node-id="573" class="node node--type-page node--view-mode-full"> <div class="view-mode-full"> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="tex2jax_process"><p>ISPE’s regulatory initiatives and programs focus on solving problems of importance to industry and supporting convergence of global regulatory and quality expectations for the benefit of patients.</p><h3>Initiatives</h3><div class="row medium-up-4 figure-list"><div class="column column-block"><h4><a href="/initiatives/advancing-pharmaceutical-quality" data-entity-type="node" data-entity-uuid="51c2d657-bc96-442f-a178-7e98e87009ec" data-entity-substitution="canonical" title="Advancing Pharmaceutical Quality™"><img class="thumbnail" src="/sites/default/files/assets/images/regulatory/quality-metrics-square.png" data-entity-uuid="0" data-entity-type="image" alt="quality metrics" width="300"></a><br><a href="/initiatives/advancing-pharmaceutical-quality" data-entity-type="node" data-entity-uuid="51c2d657-bc96-442f-a178-7e98e87009ec" data-entity-substitution="canonical" title="Advancing Pharmaceutical Quality™">Advancing Pharmaceutical Quality™</a></h4></div><div class="column column-block"><h4><a href="/initiatives/drug-shortages" data-entity-type="node" data-entity-uuid="d89f703a-a18a-46ca-8eac-d6748c5de316" data-entity-substitution="canonical" title="Drug Shortages Initiative"><img class="thumbnail" src="/sites/default/files/assets/images/regulatory/drug-shortages-square.jpg" data-entity-uuid="0" data-entity-type="image" alt="drug shortages" width="300"></a><br><a href="/initiatives/drug-shortages" data-entity-type="node" data-entity-uuid="d89f703a-a18a-46ca-8eac-d6748c5de316" data-entity-substitution="canonical" title="Drug Shortages Initiative">Drug Shortages</a></h4></div><div class="column column-block"><h4><a href="/initiatives/regulatory/enabling-global-pharmaceutical-innovation-delivering-patients" title="Enabling Global Pharmaceutical Innovation: Delivering for Patients" data-entity-type="node" data-entity-uuid="48964946-9e30-4da9-a80b-f073622003f1" data-entity-substitution="canonical"><img class="thumbnail" src="/sites/default/files/regulatory/Quality-culture2021-537px.jpg" data-entity-uuid="0" data-entity-type="image" alt="Quality Culture" width="300"></a><br><a href="/initiatives/regulatory/enabling-global-pharmaceutical-innovation-delivering-patients" title="Enabling Global Pharmaceutical Innovation: Delivering for Patients" data-entity-type="node" data-entity-uuid="48964946-9e30-4da9-a80b-f073622003f1" data-entity-substitution="canonical">Enabling Pharmaceutical Innovation</a></h4></div><div class="column column-block"><h4><a href="/initiatives/pqli" title="Product Quality Lifecycle Implementation (PQLI) ®" data-entity-type="node" data-entity-uuid="34a36322-a725-4249-9a28-d2eb08ee1834" data-entity-substitution="canonical"><img class="thumbnail" src="/sites/default/files/regulatory/2023/PQLI-600px.jpg" data-entity-uuid="0" data-entity-type="image" alt="Product Quality Lifecycle Implementation" width="300"></a><br><a href="/initiatives/pqli" title="Product Quality Lifecycle Implementation (PQLI) ®" data-entity-type="node" data-entity-uuid="34a36322-a725-4249-9a28-d2eb08ee1834" data-entity-substitution="canonical">Product Quality Lifecycle Implementation®</a></h4></div></div><h3>Current Topics</h3><table><tbody><tr style="background-color:#f5f5f5;"><td class="text-align-center" style="padding:20px;"><a href="https://ispe.org/initiatives/pqli#accelerated-development " title="Accelerated Development & Manufacturing">Accelerated Development & Manufacturing</a></td><td class="text-align-center" style="padding:20px;"><a href="https://ispe.org/initiatives/pqli#analytical-method" title="Analytical Method Strategy / ICH Q2(R2), Q14">Analytical Method Strategy / ICH Q2(R2), Q14</a></td><td class="text-align-center" style="padding:20px;"><a href="https://ispe.org/initiatives/pqli#continuous-manufacturing" title="Continuous Manufacturing">Continuous Manufacturing</a></td><td class="text-align-center" style="padding:20px;"><a href="https://ispe.org/initiatives/pqli#ich-q9" title="ICH Q9(R1)">ICH Q9(R1)</a></td></tr><tr style="background-color:#f5f5f5;"><td class="text-align-center" style="padding:20px;"><a href="https://ispe.org/initiatives/pqli#ich-q12" title="ICH Q12 Implementation">ICH Q12 Implementation</a></td><td class="text-align-center" style="padding:20px;"><a href="https://ispe.org/initiatives/pqli#patient-centric-specifications" title="Patient Centric Specifications">Patient Centric Quality Standards</a></td><td class="text-align-center" style="padding:20px;"><a href="https://ispe.org/initiatives/pqli#process -validation" title="Process Validation">Process Validation</a></td><td class="text-align-center" style="padding:20px;"><a href="https://ispe.org/initiatives/pqli#transportable" title="Transportable/POC Manufacturing">Transportable/POC Manufacturing</a></td></tr></tbody></table><hr><h2>ISPE Regulatory Digest Newsletter</h2><div class="row medium-up-2"><div class="column column-block"><p><img src="/sites/default/files/regulatory/regulatory-digest/2024/ai-technology-microchip-background-digital-transformation-concept-Image%20by%20rawpixel.com%20on%20Freepik-750px%20(1).jpg" alt="FDA on AI in Pharmaceutical Manufacturing"></p><h4><a href="/initiatives/regulatory/newsletter/regulatory-digest-q3-2024" title="ISPE Regulatory Digest Q3 2024" data-entity-type="node" data-entity-uuid="d8dd508f-36b0-4244-b9ce-af0f9aa90055" data-entity-substitution="canonical">ISPE Regulatory Digest Q3 2024</a></h4><ul><li>FDA on AI in Pharmaceutical Manufacturing</li><li>A Holistic Approach to Supply Resiliency</li><li>ISPE Regulatory Perspectives in Pharmaceutical Engineering® Magazine</li><li>Quality Management Maturity Industry Study</li></ul></div><div class="column column-block"><p><img src="/sites/default/files/regulatory/2024/Carla%20J.%20Lundi-blog%20post.jpg"></p><h4><a href="/initiatives/regulatory/newsletter/regulatory-digest-q1-2024" title="ISPE Regulatory Digest Q1 2024" data-entity-type="node" data-entity-uuid="66057d6c-cdaf-447f-b128-8de297340588" data-entity-substitution="canonical">ISPE Regulatory Digest Q1 2024</a></h4><ul><li>Quality Beyond CGMP: FDA Initiatives</li><li>Advancing Digitalization in Manufacturing: EU Initiatives</li><li>Regulators Discuss AI and its Effects on Regulatory Issues</li><li>Regulatory Challenges and Reform in Asia-Pacific</li></ul></div></div><p class="text-align-center"><a href="/initiatives/regulatory/newsletter" title="Regulatory Digest Newsletter" data-entity-type="node" data-entity-uuid="19b6af05-2abe-4e4e-96af-20a2d6138cd4" data-entity-substitution="canonical">View All Newsletters</a></p><hr><h2>ISPE Reports</h2><div class="row"><div class="columns medium-4"><p><img src="/sites/default/files/regulatory/2024/EnablingPhrmaInnov-Cover-v2_thumbnail.jpg" alt="Enabling Pharmaceutical Innovation: A report on the Barriers to Innovations Survey" width="200"></p></div><div class="columns medium-8"><p><strong>Enabling Pharmaceutical Innovation: A report on the Barriers to Innovations Survey </strong></p><p>During the last decade, industry has experienced a proliferation of regulatory divergence with respect to the interpretation and implementation of ICH guidelines (and control strategies) across geographic regions. In 2023 ISPE conducted a survey to gather data on the extent and severity of challenges/barriers globally in developing and implementing innovative technologies. The Report on the Barriers to Innovation Survey contains survey background, ssummaries of findings, conclusions and recommendations, and a discussion of next steps. Complete survey results are included in an Appendix.</p><p><a class="button success" href="/sites/default/files/regulatory/2024/Report%20EnabPrmaInnov.pdf" title="Enabling Pharmaceutical Innovation: A report on the Barriers to Innovations Survey">Download Report</a></p></div></div><hr><div class="row"><div class="columns medium-4"><p><a href="/publications/guidance-documents/ispe-readiness-report-bundle" title="ISPE Readiness Report Bundle" data-entity-type="node" data-entity-uuid="06bcaccb-87b3-430a-ad69-7865e74b3b28" data-entity-substitution="canonical"><img src="/sites/default/files/regulatory/2023/ISPEReport-SupportHERA_260px.jpg" data-entity-uuid="0" data-entity-type="image" alt="Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients" width="200"></a></p><p class="m-t-2"><a href="/publications/guidance-documents/ispe-readiness-report-bundle" title="ISPE Readiness Report Bundle" data-entity-type="node" data-entity-uuid="06bcaccb-87b3-430a-ad69-7865e74b3b28" data-entity-substitution="canonical"><img src="/sites/default/files/regulatory/2023/ISPEReport-IncreaseAPIs_260px.jpg" data-entity-uuid="0" data-entity-type="image" alt="Report on ISPE work to support European Union Health Emergency Preparedness and Response Authority " width="200"></a></p></div><div class="columns medium-8"><p><strong>Report on ISPE work to support European Union Health Emergency Preparedness and Response Authority</strong></p><p>In 2022 ISPE worked with McKinsey and Company to provide technical and Chemistry, Manufacturing, and Controls (CMC) information on two workstreams to inform the newly, created European Commission Directorate-General, Health Emergency Preparedness and Response Authority (DG HERA). The workstreams were stockpiling antimicrobial resistance medical countermeasures, and flexible manufacturing and innovation countermeasures. This report summarizes the discussions and recommendations made by ISPE to the projects.</p><p><strong>Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients</strong></p><p>ISPE produced this report in response to a request from the US Department of Air Force Acquisition COVID-19 Task Force (DAF ACT) to advise regulatory, technical, and workforce elements favorable to creating a more robust and sustainable domestic pharmaceutical manufacturing base for Active Pharmaceutical Ingredients (APIs). The report lays out technical, regulatory and workforce changes that stakeholders in any country or region could consider to reduce the risks of API shortages to meet demands for essential medicines at any time, but particularly in pandemics and other emergencies.</p><p><a class="button success" href="/publications/guidance-documents/ispe-readiness-report-bundle" title="ISPE Readiness Report Bundle" data-entity-type="node" data-entity-uuid="06bcaccb-87b3-430a-ad69-7865e74b3b28" data-entity-substitution="canonical">Download Bundle</a></p></div></div><hr><h2>Additional Regulatory Resources</h2><h3>Regulations, Guidelines & Other Documents</h3><p>A select list of recently released regulations, guidelines and other documents compiled by the ISPE Regulatory Quality Harmonization Committee (RQHC)’s Europe-Middle East-Africa Regional Focus Group</p><p><a class="button" href="/initiatives/regulatory/updates" title="Regulatory News and Updates" data-entity-type="node" data-entity-uuid="c38678bf-1b73-404a-b744-b2b9a7d25cb2" data-entity-substitution="canonical">Regulatory News & Updates</a></p><hr><h3><strong>International, Regional & National Authorities</strong></h3><p>A select list of global regulatory organizations.</p><p><a class="button" href="/initiatives/regulatory/resources" title="Regulatory Resources" data-entity-type="node" data-entity-uuid="36a6cdf4-7416-4bcd-ad33-9916b0f1a6f4" data-entity-substitution="canonical">View Agencies</a></p><hr><h3>GAMP<sup>®</sup></h3><p>Created to address evolving FDA and other regulatory agency expectations for computerized system compliance and validation, <strong>GAMP<sup>®</sup></strong> good practices are used globally by regulated companies and their suppliers, and are widely supported by regulatory agencies.</p><p><a class="button" href="/initiatives/regulatory/what-gamp" title="What is GAMP®" data-entity-type="node" data-entity-uuid="b0b18818-0fb2-42aa-80ae-0e6e34aff6ed" data-entity-substitution="canonical">GAMP<sup>®</sup><strong><sup> </sup></strong>RESOURCES</a></p><hr><h3>Good Manufacturing Practice GMP</h3><p>Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.</p><p>GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. 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