FDA Food and Drug Administration
FDA Code of Federal Regulations Mini-Handbooks!
Or Call 856-810-7331  Fax: 856-810-7339


Select below
which handbook is right for you, and if not sure, please call our Regulatory Department at 856-810-1825 or email at sales@gmppublications.com

CFR Rule Changes by GXPNews


ICH Q-Series Handbooks

International Conference of Harmonization (ICH) Handbooks

Q - Series

ICH Quality Series Handbooks

 

Select from list below - Click Here to Mix & Match! 
If you don't see what you need, please call 856-810-7331

   
Basic EU & US GMPs with Annexes 11 - 15
$13.90
5 Book Minimum! Basic EU GMPs Chapter 1 through 9 and US GMPs, 11 Electronic Systems, 210/211 Drug GMPs, 820 QSR, with Annex 11 Computerized Systems - Annex 15 Qualification and Validation
Quantity
   
Basic EU GMPs with Annex 11, 15, 16 and ICH Q7
$10.90
5 Book Minimum! Basic GMPs Chapter 1 through 9 with Annex 11 Computerized Systems - Annex 15 Qualification and Validation - Annex 16 Certification by a Qualified Person and Batch Release - Annex 18 Q7 APIs
Quantity
   
Basic EU GMPs with Annex 11, 15, 16, 18, 19
$11.50
5 Book Minimum! Basic GMPs Chapter 1 through 9 with Annex 11 Computerized Systems - Annex 15 Qualification and Validation - Annex 16 Certification by a Qualified Person and Batch Release - Annex 18 Q7 APIs and Annex 19 Reference and Retention Samples
Quantity
   
Basic EU GMPs with US Standard GMPs
$12.90
5 Book Minimum! Basic EU GMPs and US Standard GMP Combination including EU Chapters 1 through 9, US 21 CFR Parts 11, 210/211, 820 and ICH Q7 (Annex 18 / Part II)
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500+  
Price $12.90 $12.80 $12.50 $11.00
   
Basic EU and US GMPs with ICH Q7, Q8, Q9 and Q10
$13.90
5 Book Minimum! Basic EU GMPs Chapter 1 through 9 with US 21 CFR Parts 11, 210/211, 820 and ICH Q7 (Annex 18), Q8, Q9 and Q10
Quantity
   
Basic EU GMPs Chapter 1 - 9
$6.90
5 Book Minimum! Basic EU GMPs Chapter 1 through 9 with Glossary
Quantity
ICH Q10
$3.20
Step 3 Pharmaceutical Quality Systems Handbook
ICH Q1A
$3.20
Stability Testing of New Drug Substances and Products (2nd Revision)
ICH Q1E
$3.20
Evaluation of Stability Data
ICH Q2B
$3.20
Validation of Analytical Procedures : Methodology
ICH Q5E
$3.20
Comparability of Biotechnological / Biological Products Subject to Changes in their Manufacturing Process
ICH Q7
$3.20
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICH Q7, Q8, Q9 & Q10 Combination
Quantity   1 - 99    100 - 249    250 - 499    500+  
Price $7.90 $7.60 $7.25 $6.50
ICH Q8
$3.20
Pharmaceutical Development
ICH Q8 and Q9
$5.95
Combination Booklet Q8 - Pharmaceutical Development Q9 - Quality Risk Management
ICH Q8, Q9 & Q10 Combination
$6.90
Combination Handbook for Pharmaceutical Quality Includes; Q8 - Pharmaceutical Development Q9 - Quality Risk Management Q10 - Pharmaceutical Quality Systems Handbook
ICH Q9
$3.20
Quality Risk Management