(1999; 168 pages) [Spanish]
6.2 Pre-approval inspection
Inspection of manufacturing premises before approval of a marketing authorization for a new medicinal product is intended to contribute to an assurance of the product quality. The Committee was pleased to note that a first draft of provisional guidelines on pre-approval inspection had been prepared, and agreed that these should be further developed. The emphasis should be on guidance relevant to inspections carried out by small- to medium-sized drug regulatory authorities, particularly for pharmaceuticals manufactured domestically.