The GMP board game that tests and improves your GMP compliance, knowledge, attitude and awareness!
Collection of GMP's for pharmaceutical production
The GMP Handbook for pharmaceuticals
Quality Systems Handbook for MedDev
E-books: US and EU regulations
GMP translations (FR, IT, SE, DK)
Search tool and document library. Find your way in regulations, guides and other reference documents.
The regulations / guidelines as e-books on your device
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• 21 CFR Part 11 (US, Electronic Records; Electronic Signatures)
Part no: EN1361
• 21 CFR Part 210 + Part 211 (US, Pharmaceutical production)
Part no: EN1360
• 21 CFR Part 820 (US, Quality System Regulation, Medical Devices)
Part no: EN1362
• EU GMP guideline, Part I, Ch. 1-9 (Pharmaceutical production)
Part no: EN1363
• EU GMP guideline, Part II, (Pharmaceutical API production, conforms with ICH Guideline, Q7A)
Part no: EN1364
• EU GMP Annexes 1-19
Part no: EN1365
The documents are in EPUB format.
All text is fully searchable within the EPUB reader application.
Examples of free epub readers/apps
(with links to download):
Firefox with add-on EPUBReader
The built in e-book reader
The publications are single user licenses. For larger quantities (10+) we can issue a multi user license to be distributed within your organisation.
Reproduction or distribution is not allowed without the prior permission of the publisher, Lundén/Ellow ab.
The epub files are delivered via e-mail within 5 working days.
All ebooks except 21 CFR 11:
Price/licenced file (excl. VAT): |
|
1-9 lic |
20 Euro |
10-49 lic |
15 Euro |
50+ |
Contact us for offer |
21 CFR 11:
Price/licenced file (excl. VAT): |
|
1-9 lic |
15 Euro |
10-49 lic |
10 Euro |
50+ |
Contact us for offer |