Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,
These guidelines of ORA within FDA are not addressed to the industry but to the inspectors of FDA. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of manufacturers of liquid oral preparations and suspensions. The following topics are addressed therein: premises and equipment, requirements for starting materials, manufacturing methods, microbial quality, homogeneity of suspensions, specifications, stability, packaging and process validation.