Guidance for industry and FDA: Current good manufacturing practice for combination products
by FDA Center for Drug Evaluation and Research
This white paper by the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) explains the FDA's current good manufacturing practices (cGMPs) for combination products as defined under 21 CFR Part 3.2(e). Such provisions ensure that the product is not adulterated and possesses adequate strength, quality, identity and purity; and that the product complies with appropriate performance standards. For simplicity, the concepts in this paper are described in the context of a combination product composed of two constituent parts.
| Published: | 2004 |
| Format: | |
| Length: | 11 pages |
| Type: | White paper |
| Language: | English |
.
SPONSORED REPORTS
