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Publications | ISPE | International Society for Pharmaceutical Engineering
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They typically focus on the <em>how</em>.</p> <h3><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d9f533cf-16b5-4e7f-9ead-416bb4cc9768" href="/publications/guidance-documents" title="Guidance Documents">Good Practice Guides</a></h3> <p>Reflecting current regulatory expectations and best practices, Good Practice Guides (GPGs) help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.</p> <h3><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d9f533cf-16b5-4e7f-9ead-416bb4cc9768" href="/publications/guidance-documents" title="Guidance Documents">Guides</a></h3> <p>Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance. They typically focus on the “what”, but may also provide some information on implementation.</p> <ul> </ul> <h3><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="34a36322-a725-4249-9a28-d2eb08ee1834" href="/initiatives/pqli" title="Product Quality Lifecycle Implementation (PQLI) ®">Product Quality Lifecycle Implementation<sup>®</sup> (PQLI<sup>®</sup>) Guides </a></h3> <p>PQLI Guides and GPGs provide information on global solutions to implementation challenges of International Council for Harmonisation (ICH) guidances.</p> <h3><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d9f533cf-16b5-4e7f-9ead-416bb4cc9768" href="/publications/guidance-documents" title="Guidance Documents">Investigational Products (IP) Publications</a></h3> <p>Investigational Products Publications have been created to bring new investigational trial materials professionals quickly up to speed with the terms and related information they need to be successful in their field.</p> <h3><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d9f533cf-16b5-4e7f-9ead-416bb4cc9768" href="/publications/guidance-documents" title="Guidance Documents">Handbooks</a></h3> <p>Handbooks provide a comprehensive ready reference, with concise information on a particular topic, occupation, or process. They are structured to give quick answers in specific topic areas.</p> <h3><a href="/products/regulation-handbooks">GMP Regulation Handbooks</a></h3> <p>These handy pocket-size booklets are an ideal way to keep everyone informed of FDA regulations and guidelines.</p> <hr> <h2>Papers</h2> <h3><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a971c5cb-1426-41f2-b17a-81e356703a31" href="/node/122645" title="Concept & Discussion Papers">Concept Papers</a></h3> <p>Concept Papers establish or clarify a concept (or framework); they often describe a potential solution or approach to an existing problem or area of discussion. 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