US FDA finalises contract manufacturing quality agreement guidance
A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.
Archives for November 24, 2016
US FDA says Srikem plan will not fix data integrity issues at Taloja plant
The US FDA still has doubts about Srikem Laboratories’ plan to fix data integrity problems at its API manufacturing facility Taloja, India.