|
|
The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
|
|
| Q 9: ICH Draft Consensus Guideline: Q9 Quality Risk Management |
| Internet: | http://www.fda.gov/cder/guidance/7153fnl.pdf |
| Origin/Publisher: | Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; |
| Content: | This guideline provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labeling materials |
| Status: | Draft |
|
|
|
|
|
