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GMP Publications, Inc.

Food & Drug Administration (FDA)
U.S. FDA Code of Federal Regulations & EU ICH Handbooks
Tel: 856-810-7331  Fax: 856-810-7339   
sales@gmppublications.com
 

All U.S. FDA CFR handbooks updated as of April 1st. 2010 - NOW SHIPPING!

CFR Rule Changes by GXPNews

Just Released July 8, 2010 Federal Register: FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs 

Pick up your copy of the Part 11 Electronic Systems Master Handbook! - GXP Academy for On-Site Part 11 Training $6,995 (2 Day all Inclusive!) 866-GXPNews

Basic EU GMPs with Standard US GMP Combination Handbook -  $12.90 each
All of the EU GMPs and US Regulations in an easy to carry handbook

European Union GMPs  -  for Medicinal Products for
Human and Veterinary Use

  • Introduction
  • Chapter 1 – Quality Management
  • Chapter 2 – Personnel
  • Chapter 3 – Premises and Equipment
  • Chapter 4 – Documentation
  • Chapter 5 – Production
  • Chapter 6 – Quality Control
  • Chapter 7 – Contract manufacture and Analysis
  • Chapter 8 – Complaints and Product Recalls
  • Chapter 9 – Self Inspection
  • Glossary

US FDA Regulations Title 21 CFR

  • Part 11 Electronic Signatures; Electronic Records
  • Parts 210/211 Good Manufacturing Practices
  • Part 820 Quality Systems Regulations

Basic EU & US GMP Combination
$12.90 each  - 
5 Book Minimum!
Custom Logos Available!

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  1 - 99     100 - 249     250 - 499     500 - 999     1000+  
$12.90 $12.70 $12.20 $10.90 $8.95

If you would like to add any other Annex to the EU/US GMP, call 856-810-1825.

 

Other EU GMPs Combinations:  ...More

  • EU GMPs + Annex 11 + Annex 15 + Annex 16 + Annex 18 Q7 - $10.90  ...Order Now

  • EU GMPs + Annex 8 + Annex 11 + Annex 15 + Annex 16 + Annex 18 Q7 + Annex 19 - $11.00  ...More

  • EU GMPs + Annex 11 + Annex 15 + Annex 16 + Annex 13 - $11.90  ...More

  • EU GMPs + Standard GMPs - $12.90  ...More

  • EU GMPs + Standard GMPs + Q8, Q9, & Q10 - $13.90  ...More


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GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331   sales@gmppublications.com
Copyright©1998 - 2010 GMP Publications, Inc., FDA.COM and GXPNews
For technical assistance contact John Cuspilich, RA/QA GMP Publications, For sales & Marketing contact Michael Van Horn.
GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331  
sales@gmppublications.com