GMP Publications
In our GMP shop menu we offer you two sortings of our products:
according to GMP Publications or GMP Subjects
Sorting by GMP Publications is helpful if you already know products from the GMP publishing house - e.g. a "Kleiner GMP-Berater" and another volume from this series or a similar product of this kind.
If you are looking for help on a specific GMP topic - e.g. qualification - use this menu. Here you will find an overview of the various publications on this topic, from regulatory requirements to SOPs or similar.
-
Download12 Cases from an Inspector's Practice Non-compliance can be expensive. Learn from others’...
€117.00 net
-
DownloadPlanning and constructing cleanrooms is a complex task. Get to know how to successfully get...
€117.00 net
-
DownloadHandling packaging materials is a high-risk business because of the danger of mix-ups. Get to...
€117.00 net
-
A helpful guide which facilitates the entry into the GMP world and teaches the necessary basics....
€39.90 net
-
DownloadGMP-Conform Sampling and Handling of Substances Regulatory Requirements Methodological...
€117.00 net
-
DownloadWhy are Environmental Risk Assessments necessary? What evaluation phases and methods do exist?...
€0.00 net
-
DownloadA step-by-step guide to bring your drug manufacturing systems into compliance!
€117.00 net
-
DownloadCorrectly Implementing GMP and GDP Requirements Current regulatory requirements and their...
€117.00 net
-
GMP knowledge for the planning, qualification and maintenance of the pharmaceutical equipment...
€269.00 net
-
Regulatory requirements for transport and storage of pharmaceuticals Learning units...
€195.00 net
-
DownloadDo you already know how to proceed after having obtained an Elemental impurities risk...
€0.00 net
-
DownloadAre you not quite sure what an elemental impurities risk assessment looks like and would like to...
€0.00 net
-
DownloadAre you not quite sure what a PDE report looks like and would like to take a look inside? Get...
€0.00 net
-
DownloadAre you not quite sure what an OEL categorisation looks like and would like to take a look...
€0.00 net
-
DownloadThis SOP helps you to create and describe contracts correctly. Standard draft to adapt and...
€87.00 net
-
DownloadThis e-book lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ...
€345.00 net
-
DownloadNowadays all regulatory authorities focus on data integrity and have their own data integrity...
€345.00 net
-
DownloadA step-by-step guide based on real-world examination experience. Discover how to document...
€345.00 net
-
Download
-
DownloadWhat is the GMP-compliant approach and what do the single steps in the process flow look like?...
€87.00 net
-
DownloadIntroducing and implementing an EBR system requires systematic analysis, definition and...
€87.00 net
-
DownloadThis e-book shows how you can establish an effective CAPA system, which interfaces there are to...
€87.00 net
-
DownloadVarious different aspects must be considered in order to transfer documentation management,...
€87.00 net
-
DownloadA qualification serves to prove that equipment is fit for its given purpose. So far, so good....
€117.00 net
