Stability Studies Clause Samples
The Stability Studies clause outlines the requirements and procedures for testing and documenting the stability of a product over time. It typically specifies the types of studies to be conducted, the conditions under which samples are stored, and the duration of monitoring to ensure the product maintains its intended quality, safety, and efficacy. For example, it may require periodic testing of pharmaceutical batches under various temperature and humidity conditions. This clause ensures that products remain reliable throughout their shelf life, thereby protecting end users and complying with regulatory standards.
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Stability Studies. As soon as possible following execution of this Agreement, Buyer shall qualify appropriate testing sites for future stability studies. Seller shall continue through completion all on-going stability studies for the Products and provide Buyer with copies of the resulting data as available.
Stability Studies. As soon as possible following Closing, Buyer shall qualify a site as a testing site for stability studies or request Patheon to continue to conduct such stability studies at Buyer's expense, for Products not manufactured by Patheon. Seller shall have no responsibility for on-going stability studies for the Products following Closing.
Stability Studies. Will conduct PRODUCT stability studies in accordance with CGMP and the applicable Regulatory Filings. X ***Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Stability Studies. Patheon shall conduct stability studies on the Finished Products according to the Specifications therefor, as required by the FDA or Foreign Regulatory Authorities as advised by Santarus or as requested by Santarus, and in any case on at least one batch of Finished Product from the Facility at least once per calendar year following Commencement of Commercial Manufacturing or more frequently as may be specified in the Quality Agreement. Patheon shall provide to Santarus a report of all results and data obtained from such stability studies annually or more frequently as may be specified in the Quality Agreement.
Stability Studies. Bachem will run stability testing under ICH conditions according to the relevant Bachem’s SOP.
Stability Studies. MedImmune will continue to provide updates on the stability studies within [**] days after results become available under the stability study protocols, which will be provided to Kolltan. MedImmune will charge a fee of $[**] for completion of the currently underway stability studies for Inventory. To the extent that new stability studies for Inventory are required due to unforeseen circumstances, the Parties will discuss and agree on a reasonable fee.
Stability Studies. If so requested by Theravance, Hospira will perform stability studies on the Product separate and apart from the Project. Hospira will invoice Theravance for any such stability studies at the prices set forth in Exhibit 3.2. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Stability Studies. In accordance with requirements of the Statement of Work, Pfizer will prepare pre-market, and if requested by ▇▇▇▇▇▇▇, market-life stability batches of Products and perform stability studies (“Stability Work”). The essential obligations of the Parties regarding Stability Work and the charges therefor are set forth on Schedule 3.2.
Stability Studies. The Client will develop and validate stability indicating assay(s) prior to process validation. If required, Patheon may assist with this activity. If applicable, Patheon will conduct stability studies in accordance with the agreed and validated stability testing analytical methods at the agreed upon testing points in accordance with the agreed stability protocol. Patheon will perform the stability testing described in a stability protocol agreed to by both Patheon and the Client. Stability data will be provided by Patheon to the Client on an ongoing basis as agreed to by both parties.
Stability Studies. Celladon shall conduct stability studies on Product from the Engineering Batches manufactured by Novasep hereunder in accordance with study protocols approved by the POT prior to Novasep commencing the manufacture of Validation Batches under Section 3.5 above. Celladon shall prepare and deliver to Novasep written reports setting forth the results of such stability studies.