US and EU GMPs as E-books

For computers, tablets and iPhone / Smarthone

The regulations / guidelines as e-books on your device

Get the GMP's for Pharmaceutical production:

• 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

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Technical information

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):

PC

Adobe® Digital Editions

Firefox with add-on EPUBReader

Mac

Adobe® Digital Editions

Stanza

iPhone / iPad

The built in e-book reader

Stanza

Android

Google books

Aldiko Book Reader

Copyright / e-book license

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, Key2Compliance AB.

Delivery

The epub files are delivered via e-mail within 5 working days.

Prices

All ebooks except 21 CFR 11:

21 CFR 11:

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