Quality Unit
You are responsible for Good Manufacturing Practice (GMP).
We provide the essential information you need: GMP expert knowledge to base your decisions on.
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DownloadFor auditors and manufacturers of drugs and APIs. More than 650 typical questions related to...
€249.00 net
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DownloadFor the transport and storage of medicinal products for human use, active substances and...
€249.00 net
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DownloadGMP-Conform Sampling and Handling of Substances Regulatory Requirements Methodological...
€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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DownloadA step-by-step guide to bring your drug manufacturing systems into compliance!
€117.00 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 e-book covers all aspects you have to consider when transferring! Including an example...
€117.00 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...
€87.00 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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DownloadHow can occured failures be avoided in the future? Start to treat the root cause, not the...
€87.00 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
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DownloadThe introduction of a LDMS has an extremely positive impact on the efficiency and quality of the...
€87.00 net
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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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DownloadHandling packaging materials is a high-risk business because of the danger of mix-ups. Get to...
€117.00 net
