NDMA Seminar Views Inspections, OTC ADRs

In fiscal 1996, the US Food and Drug Administration inspected 290foreign establishments, according to Patricia Beers Block, special assistant to the Center for Drug Evaluation and Research's Office of Compliance division of manufacturing and product quality.

She told the Nonprescription Drug Manufacturers Association's annual manufacturing controls seminar (Marketletter November 25) that 183 of these inspections were of active pharmaceutical ingredients manufacturers, 11 were both API and finished drug manufacturers, 74 were finished dosage manufacturers alone, 16 contract laboratoriess, a contact micronizer and four drug repackers. One drug warehouse was also inspected. There were 49 inspections in Japan, 32 in Italy, 26 in the UK, 22 in Canada, 18 in France, 16 in Germany, 15 in Switzerland, 14 in Spain and 10 each in China and Ireland.

Most Common GMP Deficiencies Found Of the 290 inspections, 18% required no action, 67% resulted in voluntary action and 15% needed official action, she said. The most common Good Manufacturing Practice deficiencies found at foreign API manufacturers were lab controls (16%), buildings/facilities (4%), equipment cleaning (8%), written procedures (4%), stability programs (8%), process validation (11%), water systems (9%), process controls (12%), reprocessing/reworks (3%) and records/reports (13%). The most common deficiencies at foreign dosage manufacturers were lab controls (22%), packaging/labeling (3%), written procedures (4%), stability programs (4%), process validation (10%), water systems (5%), process controls (12%), equipment controls (5%) and records/reports (10%).