Assessment of Good Manufacturing Practices in Tablet and Capsule Manufacturers

摘要

The report profiles objectionable manufacturing practices recorded on the last inspectional form (FDA 483) given to tablet and capsule manufacturers. Establishments included in the study are those that were inspected for a tablet or capsule dosage form between October 1981 and April 1984, and were issued at least one FDA 483. Observations about objectionable practices are profiled in two ways: (1) by the ten major subparts of the regulations on Current Good Manufacturing Practices (CPR Part 211), and by (2) problem areas commonly discussed by FDA and industry personnel.