美国FDA_ 液体制剂检查指南（英文）.docVIP

GUIDE TO INSPECTIONS ORAL SOLUTIONS AND SUSPENSIONS Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). I. INTRODUCTION The manufacture and control of oral solutions and oral suspensions has presented some problems to the industry. While bioequivalency concerns are minimal (except for the antiseptic products such as phenytoin suspension), there are other issues which have led to recalls. These include microbiological, potency and stability problems. 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. Thus, this guide will review some of the significant potential problem areas and provide direction to the investigator when giving inspectional coverage. II. FACILITIES The design of the facilities are largely dependent upon the type of products manufactured and the potential for cross-contamination and microbiological contamination. For example, the facilities used for the manufacture of OTC oral products might not require the isolation that a steroid or sulfa product would require. Review the products manufactured and the procedures used by the firm for the isolation of processes to minimize contamination. Observe the addition of drug substance and powdered excipients to manufacturing vessels to determine if operations generate dust. Observe the systems and the efficiency of the dust removal system. The firms HVAC (Heating Ventilation and Air Conditioning) system may also warrant coverage particularly where potent or highly sensitizing drugs are pr