Routine Stability Program Sample Clauses
The Routine Stability Program clause establishes procedures and requirements to ensure that regular operations or processes remain consistent and reliable over time. Typically, this clause outlines the standards, monitoring methods, and corrective actions necessary to maintain stability in ongoing activities, such as manufacturing, service delivery, or system performance. By setting clear expectations and protocols, the clause helps prevent disruptions, maintain quality, and address any deviations promptly, thereby ensuring operational continuity and minimizing risks associated with instability.
Routine Stability Program. 6.5.1 ORPHAN is responsible for maintaining a Stability Program and will request samples from Drug Product lots to be placed on stability.
Routine Stability Program. 10.6.1.1 ORGANICHEM is responsible for maintaining a routine stability testing program for the API, and will provide a stability report to NEW RIVER annually or on reasonable request intervals. Stability samples will be tested [***] of the target stability pull date or as indicated per the approved stability protocol. Completed testing data will be provided to NEW RIVER [***] of the request.
10.6.1.2 NEW RIVER is responsible to provide or approve a stability indicating method to support the Routine Stability Program.
10.6.1.3 The stability program will be in compliance with any license commitments as notified by NEW RIVER. At a minimum one lot of each API, in each package type (largest to smallest, as applicable) will be placed on stability each year unless otherwise agreed to in writing by ORGANICHEM, NEW RIVER and FDA. The stability program will comply with ICH guidelines. The stability protocol or any changes must be approved by NEW RIVER QA or designee.
Routine Stability Program. P is responsible for maintaining a routine stability testing program for the PRODUCTS and will provide a report to POZEN annually or upon request. The stability program will be in compliance with any approved application commitments as notified by POZEN. At a minimum one lot of each product, of each strength and in each package type (largest and smallest) will be placed on stability each year. The stability program will generally follow ICH guidelines. The stability protocol or any changes must be approved by POZEN in writing.
Routine Stability Program. Nastech is responsible for maintaining a stability program on the finished product and will provide a stability report to LICENSEE annually and otherwise as required by LICENSEE. The stability program will be in compliance with the stability specifications specified by the applicable ANDA. Following initial commercial introduction, which requires [***] to be placed on stability testing, at least [***] of the Product, of each strength, and in each package type (largest and smallest) will be placed on stability each year. The stability program will follow ICH guidelines. The stability protocol and/or any subsequent changes will be handled in accordance with the provisions of Section 28.
Routine Stability Program. 6.5.1 Halozyme is responsible for developing and submitting to ▇▇▇▇▇▇ a routine stability-testing program for the Product. Halozyme is responsible for identifying the batch number and quantity of samples for each lot to be placed in the stability program. ▇▇▇▇▇▇ is responsible for executing the stability-testing program and providing summary reports and data per the agreed upon stability program.
Routine Stability Program. SkyePharma is responsible for maintaining a routine stability testing program for the PRODUCTS and will provide a formal stability report to Enzon annually and a data summary semi-annually. The stability program will be in compliance with the NDA commitments. At a, minimum, one lot of each product, of each strength and in each package type (largest and smallest) will be placed on stability each year. The stability program will follow ICH guidelines with the exception of humidity control and monitoring for products packaged in glass. SkyePharma will inform Enzon at the time of occurrence, of any material changes to the stability protocol for any PRODUCT. Any confirmed problems that arise as a result of the stability program will be promptly communicated by SkyePharma to Enzon.