STABILITY SYSTEM

Celebrating 25 Years of Innovation and Excellence. 1983–2008!

Cost-effective, comprehensive, & turnkey with customizability

Useful FDA Links

General

• Index for FDA Guidance Documents

Stability

• Guidance for Industry - Q1E Evaluation of Stability Data
• Guidance for Industry - Q1A Stability Testing of New Drug Substances and Products
• Guidance for Industry - Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
• FDA SAS Drug Formulation Stability Program

21 CFR Part 11

• A Comparison of the Proposed Rule and Final Rule for 21 Code of Federal Regulations, Part 11; Electronic Records; Electronic Signatures
• Guidance for Industry - Part 11, Electronic Records; Electronic Signatures - Scope and Application (posted on FDA website on 9/3/2003)
  HTML   PDF  
• Point-by-point comments by ScienTek

GMP

• Pharmaceutical cGMPS for the 21st Century -- A Risk-Based Approach: Second Progress Report and Implementation Plan