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.

Related to Routine Stability Program

  • Safety Program The Contractor shall design a specific safety program for the Work for the site(s). The Contractor shall establish and require all Subcontractors to establish reasonable safety programs. The Contractor shall also submit its standard monthly safety reports to the Owner and Design Professional. No imposition of responsibility on the Contractor for safety under this Contract shall relieve any subcontractor of its responsibility for safety of persons or property on or near the Project Site. The Contractor shall include in his plant he names of the person in charge of Safety.

  • E-Verify Program Grantee certifies that it utilizes and will continue to utilize the U.S. Department of Homeland Security's E-Verify system to determine the eligibility of: A. all persons employed to perform duties within Texas during the term of the Grant Agreement; and B. all persons, (including subcontractors) assigned by the Grantee to perform work pursuant to the Grant Agreement within the United States of America.

  • PROPOSED MOBILITY PROGRAMME The proposed mobility programme includes the indicative start and end months of the agreed study programme that the student will carry out abroad. The Learning Agreement must include all the educational components to be carried out by the student at the receiving institution (in table A) and it must contain as well the group of educational components that will be replaced in his/her degree by the sending institution (in table B) upon successful completion of the study programme abroad. Additional rows can be added as needed to tables A and B. Additional columns can also be added, for example, to specify the study cycle-level of the educational component. The presentation of this document may also be adapted by the institutions according to their specific needs. However, in every case, the two tables A and B must be kept separated, i.e. they cannot be merged. The objective is to make clear that there needs to be no one to one correspondence between the courses followed abroad and the ones replaced at the sending institutions. The aim is rather that a group of learning outcomes achieved abroad replaces a group of learning outcomes at the sending institution, without having a one to one correspondence between particular modules or courses. A normal academic year of full-time study is normally made up of educational components totalling 60 ECTS* credits. It is recommended that for mobility periods shorter than a full academic year, the educational components selected should equate to a roughly proportionate number of credits. In case the student follows additional educational components beyond those required for his/her degree programme, these additional credits must also be listed in the study programme outlined in table A. When mobility windows are embedded in the curriculum, it will be enough to fill in table B with a single line as described below: Component code (if any) Component title (as indicated in the course catalogue) at the sending institution Semester [autumn / spring] [or term] Number of ECTS* credits Mobility window … Total: 30 Otherwise, the group of components will be included in Table B as follows: Component code (if any) Component title (as indicated in the course catalogue) at the sending institution Semester [autumn / spring] [or term] Number of ECTS* credits Course x … 10 Module y … 10 Laboratory work … 10 Total: 30 The sending institution must fully recognise the number of ECTS* credits contained in table A if there are no changes to the study programme abroad and the student successfully completes it. Any exception to this rule should be clearly stated in an annex of the Learning Agreement and agreed by all parties. Example of justification for non-recognition: the student has already accumulated the number of credits required for his/her degree and does not need some of the credits gained abroad. Since the recognition will be granted to a group of components and it does not need to be based on a one to one correspondence between single educational components, the sending institution must foresee which provisions will apply if the student does not successfully complete some of the educational components from his study programme abroad. A web link towards these provisions should be provided in the Learning Agreement. The student will commit to reach a certain level of language competence in the main language of instruction by the start of the study period. The level of the student will be assessed after his/her selection with the Erasmus+ online assessment tool when available (the results will be sent to the sending institution) or else by any other mean to be decided by the sending institution. A recommended level has been agreed between the sending and receiving institutions in the inter-institutional agreement. In case the student would not already have this level when he/she signs the Learning Agreement, he/she commits to reach it with the support to be provided by the sending or receiving institution (either with courses that can be funded by the organisational support grant or with the Erasmus+ online tutored courses). All parties must sign the document; however, it is not compulsory to circulate papers with original signatures, scanned copies of signatures or digital signatures may be accepted, depending on the national legislation. * In countries where the "ECTS" system it is not in place, in particular for institutions located in partner countries not participating in the Bologna process, "ECTS" needs to be replaced in all tables by the name of the equivalent system that is used and a weblink to an explanation to the system should be added. The section to be completed during the mobility is needed only if changes have to be introduced into the original Learning Agreement. In that case, the section to be completed before the mobility should be kept unchanged and changes should be described in this section. Changes to the mobility study programme should be exceptional, as the three parties have already agreed on a group of educational components that will be taken abroad, in the light of the course catalogue that the receiving institution has committed to publish well in advance of the mobility periods and to update regularly as ECHE holder. However, introducing changes might be unavoidable due to, for example, timetable conflicts. Other reasons for a change can be the request for an extension of the duration of the mobility programme abroad. Such a request can be made by the student at the latest one month before the foreseen end date. These changes to the mobility study programme should be agreed by all parties within four to seven weeks (after the start of each semester). Any party can request changes within the first two to five-week period after regular classes/educational components have started for a given semester. The exact deadline has to be decided by the institutions. The shorter the planned mobility period, the shorter should be the window for changes. All these changes have to be agreed by the three parties within a two-week period following the request. In case of changes due to an extension of the duration of the mobility period, changes should be made as timely as possible as well. Changes to the study programme abroad should be listed in table C and, once they are agreed by all parties, the sending institution commits to fully recognise the number of ECTS credits as presented in table C. Any exception to this rule should be documented in an annex of the Learning Agreement and agreed by all parties. Only if the changes described in table C affect the group of educational components in the student's degree (table B) that will be replaced at the sending institution upon successful completion of the study programme abroad, a revised version should be inserted and labelled as "Table D: Revised group of educational components in the student's degree that will be replaced at sending institution". Additional rows and columns can be added as needed to tables C and D. All parties must confirm that the proposed amendments to the Learning Agreement are approved. For this specific section, original or scanned signatures are not mandatory and an approval by email may be enough. The procedure has to be decided by the sending institution, depending on the national legislation.

  • Training Program It is agreed that there shall be an Apprenticeship Training Program, the provisions of which are set forth in Exhibit "D", which is attached hereto and forms part of this Agreement.

  • Project Implementation Manual The Recipient, through the PCU, shall: (i) take all action required to carry out Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4 (ii) of the Project in accordance with the provisions and requirements set forth or referred to in the Project Implementation Manual; (ii) submit recommendations to the Association for its consideration for changes and updates of the Project Implementation Manual as they may become necessary or advisable during Project implementation in order to achieve the objective of Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4(ii) of the Project; and (iii) not assign, amend, abrogate or waive the Project Implementation Manual or any of its provisions without the Association’s prior agreement. Notwithstanding the foregoing, if any of the provisions of the Project Implementation Manual is inconsistent with the provisions of this Agreement, the provisions of this Agreement shall prevail and govern.