1. Agalloco J (1993) The validation life cycle. J Parenter Sci Technol 47(3):142–147
2. Agalloco J (2008) Sterilization process validation. In: Prince R (ed) Microbiology in pharmaceutical manufacturing, vol 1, 2nd edn. PDA/DHI, Bethesda, MD, pp 401–423
3. Annex 15 (2001) Final version of Annex 15 to the EU guide to good manufacturing practice. Working party on control of medicines and inspections. Brussels. http://www.it-asso.com/gxp/eudralex_v21/contents/vol-4/pdfs-en/v4an15.pdf . Accessed 15 July 2011
4. Anonymous (2011a) Biological process validation of dry-heat sterilization cycles. In: Pharmaceutical validation. http://pharmaceuticalvalidation.blogspot.com/2010/01/biological-process-validation-of-dry.html . Accessed 11 Sept 2011
5. Anonymous (2011b) Validating rapid micro methods. http://rapidmicromethods.com/files/validation.html . Accessed 8 Sept 2011