Stability Studies and Protocol. CPI will conduct stability studies to support the retest period and/or expiration date listed in CPI’s certificate of analysis and in accordance with the validated stability testing analytical methods in accordance with the approved stability protocol. CPI will analyze stability samples in a timely manner in accordance with cGMP and SOPs, and, prior to the DMF Approval, shall give the Regulatory Consultant the stability summary report within thirty (30) days of the approved stability testing at each time point.
Appears in 2 contracts
Sources: Supply Agreement, Supply Agreement (Neos Therapeutics, Inc.)