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Literature in english

 

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Collection of GMP's for pharmaceutical production

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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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 mostspacer common 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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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.

 

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QSIT, Guide to Inspection of Quality Systems

A reproduction of the FDAs guide from August 1999.

 

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GMP/GDP translations in handy format
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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