In the Pockets of Millions of Industry Professionals - Your Company can be too! Find out more - sales@gmppublications.com

GMP Publications - Code of Federal Regulation Handbooks by the FDA

GCLP Good Clinical Laboratory Handbook - 4.5x7.5

US FDA Title 21 CFR Parts

- 21 CFR Part 11 - Electronic Records with Scope and Application
- 21 CFR Part 58 - Good Laboratory Practice
- 21 CFR Part 312 - Investigational New Drug Application
- 21 CFR Part 314 - Applications for FDA Approval to Market a New Drug

- 42 CFR Part 493 Laboratory Requirements (HHS)

International Council for Harmonisation

- ICH E6(R3) Good Clinical Practice
- ICH Q1A(R2) Stability Testing of New Drug Substances
- ICH Q1C Stability Testing for New Dosage Forms
- ICH Q1E Evaluation of Stability Data
- ICH Q2(R2) Validation of Analytical Procedures
- ICH Q14 Analytical Procedure Development

OECD - General Principles of GLP Series 1

Quantity	1 - 99	100 - 249	250 - 499	500 - 999	1000+
Price	$24.95	$17.95	$13.95	$11.50	$9.90

Quantity

Upgrade your order or view other GMP Products that you may be interested in:

GLP Analytical Stability Handbook - 4.5x7.5

US FDA Regulations

- 21 CFR Part 11 - Electronic Records with Scope and Application
- 21 CFR Part 58 - Good Laboratory Practice
- 21 CFR Part 210/211 Drug GMPs

- 42 CFR Part 493 Laboratory Requirements (HHS)

ICH International Council for Harmonisation

- ICH Q1A(R2) Stability Testing of New Drugs
- ICH Q1B Photostability Testing
- ICH Q1C Stability Testing for New Dosage Forms
- ICH Q1D Bracketing and Matrixing Designs for Stability Testing
- ICH Q1E Evaluation of Stability Data
- ICH Q2(R2) Validation of Analytical Procedures
- ICH Q5C Stability Testing of Biological Product
- ICH Q14 Analytical Procedure Development
- ICH M10 Bioanalytical Method Validation and Study Sample Analysis

Organisation for Economic Co-operation and Development

- OECD - General Principles of GLP Series 1

FDA Guidance

- Guidance for Industry ANDAs: Stability Testing of Drug Substances

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
Contact Us