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Collection of GMP's for pharmaceutical production

The GMP Handbook for pharmaceuticals

Quality Systems Handbook for MedDev

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Basic statistics for QC-Lab

ICH Q8, Q9, Q10

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Literature

Handbooks, Guides and self study courses

For regulations and gudelines in pocket size format, click here »

For regulations and gudelines as E-books (epub), click here »

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The GMP Handbook - quality systems for the pharmaceutical industry

Your guide to the GMPs

Anna Lundén have gathered the most important GMP facts in this book. Get basic knowledge about GMP in a clear and easy to read style.
It also contains key tables about similarities and differences in the mostcommon GMP regulations and tables with specific references to requirements in the GMPs. Suitable for self studies and as reference.

Also in French and Swedish

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Quality Systems Handbook for Medical Devices

The same approach as our popular handbook for the Pharmaceutical Industry. Basic knowledge about GMP/QSR in a clear and easy to read style.

Covers both ISO 13485 and US QSR (21 CFR 820).

Suitable for self studies and as reference.

Also in and Swedish

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ICH Q8/Q9/Q10 with GMP and ISO 9001 references

All 3 Q-guides compiled in a handy format.

Includes a reference matrix for getting an overview of the four basic enablers and Quality System elements.

All the references have coulor markings in the guideline text.

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Basic statistics in QC-lab environment

A self study course specially for QC-lab personnel. Suits both experienced personel who need to brush up their knowledge as well as the ones new to statistic data analysis.