Stability Program Clause Examples
A Stability Program clause outlines the requirements and procedures for maintaining the consistent performance and reliability of a product, system, or process over time. Typically, it mandates regular monitoring, testing, and documentation to ensure that the subject remains within specified parameters throughout its intended lifecycle. For example, in pharmaceutical contracts, this clause may require periodic stability testing of drug batches to confirm their safety and efficacy. The core function of this clause is to ensure ongoing compliance with quality standards and to mitigate risks associated with product degradation or failure.
Stability Program. During the term of this Agreement and upon Customer’s request and BVL’s written agreement, BVL will conduct and support, at Customer’s reasonable expense, all stability studies in progress or planned (e.g., NDA annual stability studies) as of the Effective Date until such studies are concluded. Customer shall be responsible for all costs of conducting any stability studies. Stability program costs will be covered in a separate quotation provided by BVL to Customer based on the agreed upon protocol. Customer may also make arrangements for stability work to be performed at a facility other than BVL at Customer’s expense.
Stability Program. Sanofi-aventis US or its designated Affiliate will perform stability study on the final validation batches on stability program following its internal established programs based on typical ICH stability guidelines for Zone I & II climate. The stability study will be carried out at 25C/60%RH through product expiry and under accelerated conditions at 40C/75%RH up to 6 months. Samples will be stored at 30C/65%RH but will not be tested unless required (subject to an additional fee). The program includes bulk tablets hold time study (up to 6 months), three validation batches carried out to a 5 year program, and one batch per year for routine study to support product shelf life confirmation. If there are requests to include additional conditions that are not typically required for the conditions mentioned above, Horizon will bear the added cost to support such additional program. Sanofi-aventis will develop stability protocol following its internal procedures. The protocol will be jointly reviewed and approved by Horizon Regulatory prior to commencing the validation stability study. Specific testing requirements and time-points will be provided in the stability protocol which should include all necessary regulatory requirements to register the Facility as the manufacturing site.
Stability Program. 11.1 Customer is responsible for stability testing program. Customer may contract with BVL to perform stability testing under separate proposals provided to Customer by BVL based on a mutually agreed to protocol.
Stability Program. 10.1 ALLERGAN will conduct an ongoing stability program in accordance with a validated procedure including storage conditions and testing protocols for the Product necessary to meet the requirements of cGMP, Regulatory Approvals and applicable law. ICH storage conditions will be used, unless agreed otherwise by the parties.
Stability Program. During the term of the this AGREEMENT and upon CUSTOMER request and BVL agreement, BVL will conduct and support, at CUSTOMER’S expense, all stability studies in progress or planned (e.g. NDA annual stability studies) as of the Effective Date until such studies are concluded. CUSTOMER shall be responsible for all costs of conducting any stability studies. Stability Program cost will be covered in a separate quotation provided by BVL to CUSTOMER based on the agreed upon protocol. CUSTOMER may also make arrangements for stability work to be performed at a facility other than BVL at CUSTOMERS expense.
Stability Program. 4.3.1 When stability programs are carried out at INyX, INyX shall have in place written procedures to ensure the validation, calibration, and maintenance of the stability chambers.
4.3.2 Raw data shall be made available in a ▇▇▇▇▇▇ manner for review by Stiefel. INyX shall communicate any aberrant or failing results to Stiefel' Quality Control department within three (▇) working days after INyX completes the out-of-specification investigation.
4.3.3 INyX and Stiefel shall jointly develop and approve a stability ▇rotocol and determine individual company responsibilities of reporting and evaluation of data. Refer to Schedule D for a list of testing data requirements.
Stability Program. Prior to the Effective Date, ▇▇▇▇▇▇ ▇▇▇▇▇ has conducted and, thereafter, ▇▇▇▇▇▇ ▇▇▇▇▇ will continue to conduct, a stability program relating to the Placebo, Clinical Product and Finished Product according to a stability protocol meeting ICH requirements and supporting thirty (30) month dating for the Finished Product (the “Stability Program”), at ▇▇▇▇▇▇ ▇▇▇▇▇’▇ expense.
Stability Program. Under the Orders, the Provider will invoice the Company a total of $[*] in connection with the stability program.
Stability Program. SUPERNUS is responsible for the stability program. SUPPLIER will document and provide SUPERNUS with request quantity of samples to be shipped to SUPERNUS or its representatives. In the situation where SUPPLIER agrees to perform stability testing on behalf of SUPERNUS, this agreement will be in writing.
Stability Program. 4.8.1 IDEC is responsible for ensuring that a routine stability testing program for the PRODUCTS is in place.
4.8.2 The stability program will be in compliance with regulatory agency commitments.
4.8.3 The stability program will generally follow ICH guidelines.
4.8.4 Any confirmed problems that arise as a result of the stability program will be communicated promptly to SCHERING by IDEC.