FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance. May 02, 2019 By Ronald A. Rader Pharmaceutical Technology Volume 43, Issue 5, pg 62–65 FDA is often considered the ‘gold standard’ global regulator by many and the most rigorous and respected regulator of pharmaceutical products. Besides evaluating applications for new drugs, generics, and biologics, FDA regularly inspects manufacturing facilities for deficiencies. Because a great majority of drug substances (active agents), particularly generic drugs, are manufactured in foreign countries, primarily China and India, FDA inspections of pharmaceutical facilities manufacturing products for the US market are performed worldwide for both internal drug company manufacturing and outsourced contract manufacturing facilities. Click Here For Complete Article Text
|
||||||||||||||||||
| Application Sequencing | ||||||||||||||||||
|
||||||||||||||||||
| Company | Product | Process | Other Subjects | Event | Event Date | Location | Publication | Publication Date | Text Descriptor | |||||||||
|
|
|
|
|
|
|
|
|
||||||||||