Integrating good manufacturing practices during the transition from clinical trials to commercial manufacturing
by Ross Systems Inc.
Early adoption of good manufacturing practices (GMPs) can lead to a faster, lower-cost ramp-up to full commercial manufacturing, whether in house or outsourced. In fact, many elements of GMP must be in place before manufacturing begins—with appropriate quality systems and strong documentation, audit and traceability packages in place to support them. In this white paper, Ross Systems Inc. interprets compliance regulations from the U.S. Food and Drug Administration and offers recommendations for integrating GMPs during the transition from clinical trials to full manufacturing.
| Published: | 2004 |
| Format: | |
| Length: | 10 pages |
| Type: | White paper |
| Language: | English |
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