Validations and Stability Studies Sample Clauses
The 'Validations and Stability Studies' clause defines the requirements for verifying that products or processes consistently meet specified standards and remain effective over time. This clause typically mandates that the party responsible must conduct validation tests to confirm that manufacturing processes yield reliable results, and perform stability studies to ensure products maintain their intended quality throughout their shelf life. Its core function is to ensure product safety and efficacy, thereby reducing the risk of failures or recalls due to instability or unvalidated processes.
Validations and Stability Studies. (a) Initial Manufacturing Process Validation. Chemport shall as soon as practicable complete the Validation of the manufacturing process for the API in connection with the Expansion (the “Initial Manufacturing Process”) in accordance with activities set forth in the Development and Process Validation Plan at no additional cost to Amarin. The Development and Process Validation Plan shall, among other things, include activities necessary to establish the Facility as a cGMP facility, a validation plan and appropriate protocols. Without limiting the foregoing, Chemport will provide process progress reports to Amarin no less frequently than [***], which reports shall include, without limitation, reasonable details related to construction, equipment installation and process implementation, subject to redaction of any Chemport Confidential Information. Promptly following completion of Validation of the Initial Manufacturing Process, Chemport shall deliver a final report to Amarin that includes a summary of regulatory data and documentation respecting the manufacture of the API, without disclosing any confidential process information, all in compliance with applicable FDA guidelines and any other applicable Legal Requirements but subject to redaction of any Chemport Confidential Information.
(i) The Parties shall participate in project teleconferences with each other as reasonably requested by the other Party to successfully complete the Validation of the Initial Manufacturing Process. During development and Validation of the Initial Manufacturing Process, Chemport will accommodate in person technical meetings at the Facility and technical inspections as reasonably requested by Amarin. Without limiting the foregoing, during process development and in support of API process characterization and Validation activities, Amarin will be permitted to conduct reviews of the Facility and the pertinent records maintained by Chemport, subject to restriction on access to all Chemport Confidential Information, in connection with the conduct of manufacturing, storage and testing of API, all upon Amarin’s request and with reasonable notice to permit Chemport to support such technical reviews.
(ii) In conjunction with the foregoing Validation pursuant to the Development and Process Validation Plan, Chemport will produce process Validation Batches. Amarin shall be required to purchase Validation Batches of API provided that they comply with the API Specifications and Validation ac...
Validations and Stability Studies. Grifols shall perform all validations and stability studies required by the Specifications, cGMPs, Applicable Laws, and the Quality Agreement in connection with the regular course of manufacturing the Products for commercial supply, subject to the prior written approval of Cadence’s authorized quality assurance representative of all such studies, including the protocols and methodology therefor. Cadence shall pay Grifols reasonable fees for performing such studies in accordance with the schedule set forth in Exhibit C to this Agreement (the “Service Fees”).
Validations and Stability Studies