Stability Testing definition

Stability Testing means the formal shelf life testing of the Product in each packaging configuration according to current USP standards.
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Stability Testing means the storage of the Product in defined packaging configurations, under controlled temperature and humidity conditions, for the purpose and execution of periodic testing of the Product according to any protocol approved by both Parties.
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Stability Testing shall have the meaning set forth in Section 10.3.10.
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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.


More Definitions of Stability Testing

Stability Testing shall have the meaning set forth in Section 4.2 of this Agreement. * The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission.
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Stability Testing shall have the meaning set forth in Section 4.2 of this Agreement.
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Related to Stability Testing

  • COVID-19 test means a viral test for SARS-CoV-2 that is:

  • Testing means that element of inspection that determines the properties or elements, including functional operation of materials, equipment, or their components, by the application of established scientific principles and procedures.

  • Biomarker testing means the analysis of an Insured’s tissue, blood, or other biospecimen for the presence of a Biomarker. "Biomarker testing" includes but is not limited to single-analyte tests, multi-plex panel tests, protein expression, whole exome, whole genome, and whole transcriptome sequencing.

  • Penetration Testing means security testing in which assessors mimic real-world attacks to identify methods for circumventing the security features of an application, system, or network. (NIST SP 800-115)

  • Test means such test as is prescribed by the particulars or considered necessary by the Inspecting Officer whether performed or made by the Inspecting Officer or any agency acting under the direction of the Inspecting Officer;