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GMP Knowledge
In our GMP e-books you will find detailed information and many useful example documents for direct implementation.
Use the e-books developed by GMP experts to deepen your specialist knowledge:
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Download NEW12 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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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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DownloadThe EU GMP Guide Annex 1 on sterile manufacturing of 2008 in comparison to the drafts of 2017...
€97.00 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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DownloadHow can occured failures be avoided in the future? Start to treat the root cause, not the...
€87.00 net
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DownloadStep-by-step through the whole qualification process of water treatment systems including sample...
€117.00 net
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DownloadThis e-book covers all aspects you have to consider when transferring! incl. an example of a...
€117.00 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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DownloadNowadays all regulatory authorities focus on data integrity and have their own data integrity...
€345.00 net
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DownloadThis SOP helps you to create and describe contracts correctly. Standard draft to adapt and extend
€87.00 net
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DownloadAsk your supplier the right questions – this questionnaire will help you! Standard draft to...
€87.00 net
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DownloadA qualification serves to prove that equipment is fit for its given purpose. So far, so good....
€117.00 net
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DownloadThis e-book shows how you can establish an effective CAPA system, which interfaces there are to...
€87.00 net
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DownloadSOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis" Standard draft to adapt and...
€87.00 net
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DownloadThis sample document defines framework conditions and processes between contract givers and...
€87.00 net
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DownloadDoes your cleaning validation meet the current requirements of Annex 15 to the EU GMP...
€117.00 net
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DownloadVarious different aspects must be considered in order to transfer documentation management,...
€87.00 net
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DownloadIntroducing and implementing an EBR system requires systematic analysis, definition and...
€87.00 net
