Release Specifications definition

Release Specifications means the tests and limits against which raw material, intermediate and final product are measured prior to use and/or release.

Release Specifications means, the set of analytical tests, methods, and acceptance criteria required to determine Gemstones radio analytical attributes that must be met in order to prove that the Gemstones meet the applicable international or domestic standards for “Exempt Material”. Release Specifications may be amended from time to time by written agreement of the parties and as dictated by applicable laws and regulations.

Release Specifications means the written release specifications dated March 8, 1993, and attached as Exhibit 1.7.3 and which shall in no event be inconsistent with the ELA/PLA Specifications or Manufacturing Specifications. .4 With respect to jurisdictions other than the United States, the Beta Specifications shall be deemed to be the product specifications and manufacturing processes and in-process specifications established under applicable licenses or regulations in such jurisdictions, together with the release specifications for such jurisdictions as are reasonably agreed to by the Parties.

Examples of Release Specifications in a sentence

• The Vendor represents itself as having the necessary resources, expertise, staff, products, services and skill, technical knowledge and experience to fully meet the requirements of KCSA in relation to the Goods and/or Services.

• Staffing Standards The contractor shall have a paging device or answering service number so that he/she may be contacted by the agency contact 24 hours per day by telephone or pager.

• Your current procedure QTP-1694-14 – Triage Family Final Release Specifications, Revision E, which is utilized by your firm for the final release specifications associated with your cardiac marker product lines, is not in alignment with the package inserts with respect to %CV.

• Your firm has changed the Triage TOX Final Release Specifications to reject any lot with one or more failures at (b)(4).

• EXHIBIT A DENDREON KNOW-HOW Dendreon "Know-How" would also relate to information (clinical protocols, Batch Record, SOP's, Release Specifications, minutes from meetings, and other Dendreon documents) that was discussed and memorialized at previous Kirin-Dendreon Meetings.

More Definitions of Release Specifications

Release Specifications means the set of analytical tests, methods, and acceptance criteria for Product attributes which must be met in order to prove the Product meets the standards of quality, purity, identity and strength for this substance. Release Specifications are a critical part of the Process and are filed with the FDA as part of an IND, MF or an NDA. All Release Specifications are set forth on Exhibit A attached hereto, which were established initially by NeoRx in consultation with University and which may be amended from time to time by written agreement of the Parties and which are to conform with all requirements of the FDA and applicable laws and regulations. Upon such amendment, University will implement any modified documents and/or procedures pertinent to the revised Release Specifications. Both parties have the right to propose process and specification improvements that are mutually beneficial, provided that no such improvements shall be implemented without the written approval of the other party.

Release Specifications means the Product Specifications mutually agreed by the Parties with which the Product shall comply at the time of release.

Release Specifications means the set of analytical tests, methods, and acceptance criteria for Product attributes which must be met in order to prove the Product meets the standards of quality, purity, identity and strength filed with the FDA for this substance. Release Specifications are a critical part of the Process and are filed with the FDA as part of an IND, MF or an NDA. All Release Specifications are set forth on Exhibit A attached hereto, which were established initially by NeoRx in consultation with University and which may be amended from time to time by written agreement of the Parties and to conform with all requirements of the FDA and applicable laws and regulations. Upon such amendment, University will implement any modified documents and/or procedures pertinent to the revised Release Specifications.

Release Specifications is defined in Section 15.

Release Specifications means the specifications agreed by FCDI and CENTURY in writing after completion of the Engineering Batch to which the Product manufactured in the Manufacturing Phase will have to conform, which written agreement of the Parties shall constitute an amendment to the applicable Work Order.

Release Specifications means certain physical characteristics of a Raw Material.

Release Specifications means the detailed product requirements, functional specifications and testing methodologies for the final BNP Assay or BNP Calibrator and Control, as such requirements, specifications and methodologies shall be developed by the parties in accordance with Section 3.5 and as may be modified from time to time upon mutual written agreement of the parties.