Literature in english

Get all the relevant GMP's for Pharmaceutical production in one handy booklet:

• 21 CFR Part 210 (Pharmaceutical production)
• 21 CFR Part 211 (Pharmaceutical production)
• 21 CFR Part 11  (Electronic Records; Electronic Signatures)
• EU GMP guideline, Part I, Ch. 1-9 (Pharmaceutical production)
• EU GMP guideline, Part II, (API, conforms with ICH Q7A)

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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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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.

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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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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.

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A reproduction of the FDAs guide from August 1999.

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Transalations to French, Swedish and Danish with the original text in parallell

• 21 CFR 210/211  FR, SE
• 21 CFR Part 820  FR, SE
• 21 CFR Part 11  SE
• EU GMP guideline, Part I, Ch. 1-9   FR, SE, DK  
• EU GMP guideline, Part II  FR, SE, DK
• EU GDP guide  SE

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