![]() The design of the facilities are largely dependent upon the type of products manufactured and the potential for cross-contamination and microbiological contamination. Thus, this guide will review some of the significant potential problem areas and provide direction to the investigator when giving inspectional coverage. Additionally, because the population using these oral dosage forms includes newborns, pediatrics and geriatrics who may not be able to take oral solid dosage forms and may be compromised, defective dosage forms can pose a greater risk because of the population being dosed. These include microbiological, potency and stability problems. While bioequivalency concerns are minimal (except for the antiseptic products such as phenytoin suspension), there are other issues which have led to recalls. The manufacture and control of oral solutions and oral suspensions has presented some problems to the industry. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). Note: This document is reference material for investigators and other FDA personnel. ![]() GUIDE TO INSPECTIONS ORAL SOLUTIONS AND SUSPENSIONS
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