Validation and Qualification Sample Clauses

Validation and Qualification. New Products Only The process, manufacturing and control procedures (including cleaning procedures, hold times, mixing studies, sterilization, etc.) shall be validated and qualified by Laureate utilizing equipment and personnel in the facility intended for manufacture of new products for Cytogen, or changes to Product. This will be accomplished under a separate Agreement. For Validation of equipment or procedures requested by Cytogen, Laureate will draft a Validation Protocol containing all required activities, acceptance criteria and documentation and will submit the protocol to Cytogen for review and approval. The Validation Protocol will be executed on at least three (3) batches of new product or changes to Product, unless otherwise agreed upon between Cytogen and Laureate. Exceptions encountered during the execution of the Validation Protocol will be documented and communicated within 30 days to Cytogen. Exceptions that cannot be resolved may require the Validation Protocol to be repeated on additional batches until at least three (3) consecutive batches meet all specification requirements. Laureate must document any exceptions encountered during the execution of the Validation Protocol. All related validation/qualification documents would be assembled in a validation summary report and provided to Cytogen for review and approval. Laureate would retain the original of the approved protocol and final report. Additional test methods may be developed and/or portions of validation testing may be performed by Laureate and included in the Validation Protocol. These commitments shall be detailed in the Validation Protocol. All validation work performed by Laureate in support of any new Cytogen Product will be handled in a separate Supply Agreement. Any additional validation work performed by Laureate in support of the current Product will be handled in an amendment to the current supply agreement.
Sample 1
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Validation and Qualification. Formosa is responsible to ensure that all equipment, facilities, utilities and computer systems used for the production of the GMP steps of the API are qualified or validated in accordance with all applicable GMP regulations and guidance documents and are maintained in a validated state.
Sample 1
Validation and Qualification. (1) NPS and Xxxxxx shall mutually agree in writing upon a validation and qualification documentation to ensure that any Product specific and quality related validation, such as process validation, packaging validation, analytical method validation, cleaning validation, and equipment qualification, is in accordance with GMP and the responsibilities set forth in APPENDIX 6 hereof.
Sample 1
Validation and Qualification. 23.1 Certain Millennium Authorized Contractors, as required by GMP, shall have a written Validation Plan that will result in the ability to provide documented evidence that manufacturing processes will consistently deliver Product meeting predetermined quality specifications. All operations and systems that could influence product quality, safety or efficacy must be qualified or validated as a condition of use, as follows:
Sample 1
Validation and Qualification. In accordance with EDDI internal procedure the applicable equipment, analytical and control procedures (including cleaning procedures where applicable) shall be validated and/or qualified, as applicable, by EDDI for the facility intended for use for production of the Product Intermediate. EDDI is responsible for calibration and maintenance of equipment, automated system and facilities. EDDI will determine the scope of test methodology validation required, in accordance with internal EDDI procedures and applicable regulatory guidelines. For those procedures which appear in the current USP/NF or other recognized standard references, there shall be a statement indicating the reference. For those test methods developed by EDDI, documentation supporting the test method shall be provided to MAP QA, on-site at EDDI’s Facility. For test methods developed by MAP, MAP shall supply EDDI with the supporting documentation with retaining exclusive rights to MAP. For Phase III supplies, all validation protocols used for validating Product Intermediate processes (production and testing) and equipment shall be prepared by EDDI per EDDI internal procedures. Validation protocols for validating Product Intermediate processes shall be reviewed and approved by MAP QA and EDDI prior to implementation. A summary report of process validation for such Phase III supplies shall be provided to MAP and the approved validation protocol, related validation and qualification [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. documents and final reports for such cGMP supplies shall be maintained by EDDI, including in its DMF as required by regulatory authorities. Use of Phase III supplies need to be determined prior to manufacturing to determine if validation is needed.
Sample 1
Validation and Qualification 
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Related to Validation and Qualification

  • Formation and Qualification (a) Each Borrower is duly incorporated and in good standing under the laws of the state listed on Schedule 5.2(a) and is qualified to do business and is in good standing in the states listed on Schedule 5.2(a) which constitute all states in which qualification and good standing are necessary for such Borrower to conduct its business and own its property and where the failure to so qualify could reasonably be expected to have a Material Adverse Effect on such Borrower. Each Borrower has delivered to Agent true and complete copies of its certificate of incorporation and by-laws and will promptly notify Agent of any amendment or changes thereto.

  • Incorporation and Qualification The Company has been duly organized and is validly existing as a Corporation and in good standing under the laws of the State of Colorado with the requisite corporate power and authority to own and use its properties and assets and to carry on its business as currently conducted.

  • Registration and Qualification If and whenever the Company is required to effect the registration of any Registrable Securities under the Securities Act as provided in this Article II, the Company shall as promptly as practicable:

  • Organization and Qualification The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary is in violation nor default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents. Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not have or reasonably be expected to result in: (i) a material adverse effect on the legality, validity or enforceability of any Transaction Document, (ii) a material adverse effect on the results of operations, assets, business, prospects or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse Effect”) and no Proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.

  • Diversification and Qualification 6.1. The Fund will invest the assets of each Designated Portfolio in such a manner as to ensure that the Contracts will be treated as annuity or life insurance contracts, whichever is appropriate, under the Code and the regulations issued thereunder (or any successor provisions). Without limiting the scope of the foregoing, the Fund will, with respect to each Designated Portfolio, comply with Section 817(h) of the Code and Treasury Regulation §1.817-5, and any Treasury interpretations thereof, relating to the diversification requirements for variable annuity, endowment, or life insurance contracts, and any amendments or other modifications or successor provisions to such Section or Regulations. In the event of a breach of this Article VI by the Fund, it will take all reasonable steps (a) to notify the Company of such breach and (b) to adequately diversify the affected Designated Portfolio so as to achieve compliance within the grace period afforded by Treasury Regulation §1.817-5.

  • Organization and Qualifications Customer and each of its Subsidiaries (i) is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, (ii) has the power and authority to own its properties and assets and to transact the businesses in which it presently is engaged and (iii) is duly qualified and is authorized to do business and is in good standing in each jurisdiction where it presently is engaged in business and is required to be so qualified.

  • Due Organization and Qualification Borrower and each Subsidiary is a corporation duly existing and in good standing under the laws of its state of incorporation and qualified and licensed to do business in, and is in good standing in, any state in which the conduct of its business or its ownership of property requires that it be so qualified.

  • Existence and Qualification The Contracting Party is an Oklahoma municipality, validly existing and in good standing under the laws of the State of Oklahoma, and the Contracting Party has all requisite power and authority to own, operate and lease its properties and to carry on its business as presently conducted.

  • Corporate Organization and Qualification Buyer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. Buyer has the requisite corporate power and authority to own or lease all of its properties and assets and to carry on its business as it is now being conducted.

  • Organization and Qualification of Seller Seller is a corporation and has all necessary power and authority to own, operate or lease the properties and assets now owned, operated or leased by it and to carry on the Business as currently conducted. Seller is duly licensed or qualified to do business and is in good standing in each jurisdiction in which the ownership of the Purchased Assets or the operation of the Business as currently conducted makes such licensing or qualification necessary.

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