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GMP Subjects
Are you looking for help on a specific topic? Select your subject and get an overview of our publications in this area.
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Download12 Cases from an Inspector's Practice Non-compliance can be expensive. Learn from others’...
€117.00 net
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DownloadPlanning and constructing cleanrooms is a complex task. Get to know how to successfully get...
€117.00 net
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DownloadHandling packaging materials is a high-risk business because of the danger of mix-ups. Get to...
€117.00 net
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DownloadGMP-Conform Sampling and Handling of Substances Regulatory Requirements Methodological...
€117.00 net
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DownloadWhy are Environmental Risk Assessments necessary? What evaluation phases and methods do exist?...
€0.00 net
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DownloadA step-by-step guide to bring your drug manufacturing systems into compliance!
€117.00 net
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DownloadCorrectly Implementing GMP and GDP Requirements Current regulatory requirements and their...
€117.00 net
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GMP knowledge for the planning, qualification and maintenance of the pharmaceutical equipment...
€269.00 net
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Regulatory requirements for transport and storage of pharmaceuticals Learning units...
€195.00 net
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DownloadDo you already know how to proceed after having obtained an Elemental impurities risk...
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DownloadAre you not quite sure what an elemental impurities risk assessment looks like and would like to...
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DownloadAre you not quite sure what a PDE report looks like and would like to take a look inside? Get...
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DownloadAre you not quite sure what an OEL categorisation looks like and would like to take a look...
€0.00 net
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DownloadA step-by-step guide based on real-world examination experience. Discover how to document...
€345.00 net
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DownloadDo your validation processes meet their specified requirements? This bilingual guide offers an...
€59.00 net
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DownloadHow to Meet the GMP Requirements of Annex 16 EU GMP Guide Batch release is complex and...
€117.00 net
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DownloadThis sample document defines framework conditions and processes between contract givers and...
€87.00 net
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DownloadThis SOP helps you to create and describe contracts correctly. Standard draft to adapt and...
€87.00 net
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DownloadThis e-book lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ...
€345.00 net
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DownloadNowadays all regulatory authorities focus on data integrity and have their own data integrity...
€345.00 net
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DownloadWhat is the GMP-compliant approach and what do the single steps in the process flow look like?...
€87.00 net
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DownloadIntroducing and implementing an EBR system requires systematic analysis, definition and...
€87.00 net
