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. 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. 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. 8.8.1 The SUBCONTRACTOR will execute any stability testing required by the contract and will comply with GMP requirements for Laboratory Controls for this testing.
Stability Program. The Stability Program shall be performed by THOMXX xx laid down in APPENDIX 4 hereto. The timeline for this work is laid down in the Master Projectplan including Project Timeline (Appendix 1).
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. Prior to the Effective Date, XXXXXX XXXXX has conducted and, thereafter, XXXXXX XXXXX 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 XXXXXX XXXXX’x expense.
Stability Program. 12 5.0 Audits 13 5.1 External Audits.................................................13 5.2 Internal Audits.................................................13 5.3 Vendor/Supplier Qualification Program...........................13
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.
