1. The vacuum integrity testing of lyophilizers;Dern;Pharmaceutical Engineering,2005
2. FDA Guidance, Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.
3. EU Guideline, Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use – Annex 1.
4. FDA draft Guidance, SUPAC: Manufacturing Equipment Addendum.
5. FDA Guide to Inspection of Lyophilization of Parenterals (7/93).