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. 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.
4.3.2 Raw data shall be made available in a xxxxxx manner for review by Stiefel. INyX shall communicate any aberrant or failing results to Stiefel' Quality Control department within three (0) working days after INyX completes the out-of-specification investigation.
4.3.3 INyX and Stiefel shall jointly develop and approve a stability xrotocol and determine individual company responsibilities of reporting and evaluation of data. Refer to Schedule D for a list of testing data requirements.
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. Notwithstanding its work described in Section 4.1 above, MEDIMMUNE and TXXXXX shall perform a stability program as laid down in APPENDIX 4 hereto. The timeline for this work is laid down in the Master Project plan including Project Timeline (APPENDIX 1). It is planned that TXXXXX will perform release testing for lots post approval.
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.
Stability Program. During the Term of this Agreement CONTRACTOR shall adhere to the established Stability Program for the Retained Insulin. The Parties shall use all reasonable efforts to ensure that the Stability Program is, and remains throughout the Term, compliant with the standards of the FDA, EMEA and WHO.
3.2.1 CONTRACTOR is responsible for monitoring and maintenance of the cGMP status for all relevant activities relating to storage and testing of the Retained Insulin. CONTRACTOR is responsible for qualification, calibration and validation of its facilities and equipment used in connection with the Stability Program.
3.2.2 The CONTRACTOR shall incorporate modifications into the Stability Program as reasonably requested by PMF.
3.2.3 To the extent the results of any Stability Program test supports extension of the dating of the Retained Insulin, CONTRACTOR shall update the DMF accordingly and in accordance with Section 3.1 above, or if PMF so requests, shall provide all reasonable assistance to allow PMF to do so.
