GMP Publications - Code of Federal Regulation Handbooks by the FDA

Misc Handbooks

21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH
21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH
21 CFR 110 - Food GMPs-SPANISH
21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH
21 CFR 210/211 - Drug GMPs-SPANISH
21 CFR 820 - Quality System Regulations-ENGLISH/SPANISH
21 CFR 820 - Quality System Regulations-SPANISH
Canadian GMP Guidelines 2009, Version 2 - Effective March 4, 2011
Electronic Systems Master Handbook 1
EU and US GMPs with Q7 API
EU and US GMPs with Annex 1
EU and US GMPs with Annexes 11 and 15
EU and US GMPs with ICH Q7, Q8(R2), Q9, Q10
EU GMPs Chapter 1 - 9
EU GMPs with Annex 11, 15, 16 and ICH Q7
EU GMPs with Annex 11, 15, 16, 18, 19
EU GMPs with Annex 13 Investigational medicinal Products
EU GMPs with Annex 14 Human Blood or Plasma Products
EU GMPs with Annex 15 Qualification and Validation
EU GMPs with Annex 16 Qualified Person and Batch Release
EU GMPs with Annex 19 Reference and Retention Samples
EU GMPs with Annex 2 Biological
EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products
EU GMPs with Annex 8 Sampling of Starting and Packaging Materials
EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments
EU GMPs with ICH Q7
ICH Q7 with Q7 Auditors Check List
ICH Q7, Q8(R2), Q9 and Q10 Combination
ICH Q7, Q8(R2), Q9 and Q10 with FAQ
Japanese GMP for Drugs and Quasi-drugs - 2005
Medical Device Clinical with EU Directive
US and Canadian GMPs with ICH Q7, Q8(R2), Q9, Q10
US, EU and Canadian Medical Device Combination
US, EU and Japanese GMPs
Chinese GMPs -SFDA - State Food & Drug Administration P.R. CHINA
Audit - US
VICH GL9 Animal GCP
21 CFR Part 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
GMP Desk Reference Set
21 CFR 320 - Bioavailability and Bioequivalence Requirements
11, 110, 117, 120 - Food GMPs
3 Day On-Site FDA/EU GMP Training Bootcamp - US
Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT
In Vitro Diagnostics 98/79/EC Medical Devices
ICH Q7, Q8, Q9, Q10 and Q11
Audit - US with 2 day Training
GMP Medical Device Master Reference Guide
Dietary Supplement Master Handbook
21 CFR Parts 11, 820 QSR and 830 UDI
21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master
21 CFR 4 - cGMP for Combination Products
In Vitro Diagnostics Master Handbook
GMP International Master Reference Guide
Title 21 CFR Parts 1 - End Nine Volume Set
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
August September Special Mix and Match GCP Device GMP GCP-DRUG Featured Publication
  • Guaranteed Lowest Price
  • Quantity Discounts Available
  • Always Current, Up-To-Date
  • Company Logos Available
  • Special Customizations
  • Pocket-sized 3.75" x 6.25"
  • Prep for FDA & Client Audits
  • Employee Training & Reference
  • Promotional "giveaways"
  • Tradeshows and meetings

Our Valued Clients










Return to the GMP Publications home page View your shopping cart Fax Order Form Send us your logo! Email Us