1. ICH Harmonied Tripartite Guideline. (2003). Q1A(R2), Stability Testing of New Drug Substances and Products, November; Q1B Photostability Testing of New Drug Substances and Products, November 1996; Q1C Stability Testing for New Dosage Forms, May 1997.
2. FDA Guidance for Industry. (1999). Container Closure Systems for Packaging Human Drugs and Biologics.
3. FDA Guidance for Industry. (1999). Changes to an Approved NDA and ANDA. November.
4. USP XXX, Chapters <661> and <671>.
5. Handbook of Package Engineering;Hanlon,1998