1. ICH Harmonied Tripartite Guideline, Q1A(R2). Stability testing of new drug substances and products; November 2003. 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. Container closure systems for packaging human drugs and biologics; 1999.
3. FDA Guidance for Industry. Changes to an approved NDA and ANDA; November 1999.
4. USP 37, <671>.
5. Handbook of package engineering;Hanlon,1992