Stability Testing definition
Examples of Stability Testing in a sentence
All of Mikart’s costs incurred in connection with the Validation, the Stability Testing and the storage of data related thereto shall be periodically billed to and paid by Vertical.
Mikart shall maintain Stability Testing and Validation data at its Atlanta, Georgia facilities or at such other location as agreed to by Vertical and Mikart in accordance with FDA regulations.
FRESENIUS shall start a Stability Testing Program using three suitable batches to assess the long-term stability of the Products, as described in the Project Plan of Exhibit A.
ICH Q1A, Stability Testing of New Drug Substances and Products, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, current revision.
This Agreement contains no untrue statement of a Material fact or omits to state any Material fact necessary to make the statements therein not misleading in light of the circumstances under which they were made.
Buyer undertakes not to remove the retained samples and stability testing samples located at the SP Facility as long as the Stability Testing Services Agreement is in effect.
The cost for Stability Testing shall be the cost listed in Appendix III.
API @ $[ * ]/ kg $[ * ] Bulk Pack and Fill $[ * ] Stability Testing $[ * ] Release Testing $[ * ] Set-up Fee @ $[ * ] Flat Rate $[ * ] Per campaign of less than [ * ] lots of bulk unlabeled/DSM Subtotal Product $[ * ] Manufacturing Cost Markup @ [ * ] $[ * ] Assumptions: 1 Total Direct Manufacturing Costs above based on production of one (1) lot of approximately [ * ] bottles.
Fresenius-Kabi will prepare and execute a formal Stability Program for the three TransMedics solutions, The duration of the study will be 24 months and will meet the minimum requirements of ICH Q1A: Stability Testing of New Drug Substances and Products, current revision.
When a word refers to one person,place,thing,or idea,it is singular in number.