Paul L. Pluta, PhD, is a pharmaceutical scientist with extensive pharmaceutical industry and university-level academic teaching experience. He is also Editor-in-Chief of the Journal of Validation Technology and the Journal of GXP Compliance. He may be contacted at [email protected] Alan M. Mancini, RPh, is a pharmacist with substantial pharmaceutical industry experience with the formulation, process, and package development, scale-up, technology transfer, validation, troubleshooting and optimization of dosage forms on a global basis. He also has university academic experience in pharmaceutics. He may be contacted at [email protected] Barbara A. Limburg, PharmD, is a pharmacist with extensive experience in hospital and home care pharmacy, the surveying of pharmacies for The Joint Commission, and in the instruction of both pharmacy and pharmacy technician students in academic settings. Norman Cheung, PharmD, is a practicing pharmacist with experience in hospital and home care pharmacy settings, including quality assurance and regulatory compliance of pharmacy operations.