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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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12 Cases from an Inspector's Practice Non-compliance can be expensive. Learn from others’...
€117.00 net
125.19 - 7.00
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Planning and constructing cleanrooms is a complex task. Get to know how to successfully get...
€117.00 net
125.19 - 7.00
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Handling packaging materials is a high-risk business because of the danger of mix-ups. Get to...
€117.00 net
125.19 - 7.00
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A step-by-step guide to bring your drug manufacturing systems into compliance!
€117.00 net
125.19 - 7.00
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Correctly Implementing GMP and GDP Requirements Current regulatory requirements and their...
€117.00 net
125.19 - 7.00
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The EU GMP Guide Annex 1 on sterile manufacturing of 2008 in comparison to the drafts of 2017...
€99.00 net
105.93 - 7.00
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Do your validation processes meet their specified requirements? This bilingual guide offers an...
€59.00 net
63.13 - 7.00
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How to Meet the GMP Requirements of Annex 16 EU GMP Guide Batch release is complex and...
€117.00 net
125.19 - 7.00
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How can occured failures be avoided in the future? Start to treat the root cause, not the...
€87.00 net
93.09 - 7.00
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This e-book covers all aspects you have to consider when transferring! Including an example...
€117.00 net
125.19 - 7.00
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What is the GMP-compliant approach and what do the single steps in the process flow look like?...
€87.00 net
93.09 - 7.00
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Nowadays all regulatory authorities focus on data integrity and have their own data integrity...
€345.00 net
369.15 - 7.00
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A qualification serves to prove that equipment is fit for its given purpose. So far, so good....
€117.00 net
125.19 - 7.00
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This e-book shows how you can establish an effective CAPA system, which interfaces there are to...
€87.00 net
93.09 - 7.00
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A Guide to Aseptic Processing
€117.00 net
125.19 - 7.00
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Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP...
€117.00 net
125.19 - 7.00
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Various different aspects must be considered in order to transfer documentation management,...
€87.00 net
93.09 - 7.00
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The introduction of a LDMS has an extremely positive impact on the efficiency and quality of the...
€87.00 net
93.09 - 7.00
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A step-by-step guide based on real-world examination experience. Discover how to document...
€345.00 net
369.15 - 7.00
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This e-book lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ...
€345.00 net
369.15 - 7.00
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A comprehensive step-by-step guide, which covers all aspects of selecting and managing...
€345.00 net
369.15 - 7.00