Validation and Qualification Sample Clauses

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.
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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 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.
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.
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. (2) Xxxxxx shall provide to NPS the Product quality related validation and qualification documents for review and approval. (3) Xxxxxx agrees that its suppliers of Materials, including packaging materials, substances, and excipients, shall be re-qualified as required by GMP. Therefore, Xxxxxx shall, all in accordance with the Pharmacopeia, appoint an external laboratory or other qualified party with the testing of such Materials, substances, and excipients.
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: i. Qualification of facilities, utilities and equipment used in the manufacture, testing and storage of the Product ii. Qualification of packaging equipment iii. Validation of test methods and qualification of persons performing testing iv. Validation of sanitizing and cleaning methods v. Validation of computer systems and logic controllers 23.2 Revalidation is required for transferred Products, and Products for which there has been a significant change to the manufacturing process, including materials and/or equipment. In addition, re-qualification is required for systems that undergo major change or extensive maintenance. Schering and Millennium will decide the number of batches required for revalidation based on significance of the change. This requirement will be satisfied through change control. 23.3 Except to the extent permitted in the relevant Third Party Agreement no changes shall be made to a validated process or system without the written agreement of Schering. 23.4 Millennium will provide to Schering, at Schering's request, specific process validation reports and summaries performed by Millennium, or Millennium's Authorized Contractors. EXHIBIT I LIST OF PRODUCTS INTEGRILIN(R) (eptifibatide) Injection, 0.75 mg/mL, 100 mL INTEGRILIN(R) (eptifibatide) Injection, 2.0 mg/mL, 100 mL INTEGRILIN(R) (eptifibatide) Injection, 2.0 mg/mL, 10 mL
Validation and Qualification 

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. (b) The only Subsidiaries of each Borrower are listed on Schedule 5.2(b).

  • 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 MSCI is required to effect a Demand Registration or a Piggyback Registration, MSCI shall as promptly as practicable: (a) prepare, file and use its reasonable best efforts to cause to become effective a registration statement under the Securities Act relating to the Registrable Securities to be offered; (b) prepare and file with the SEC such amendments and supplements to such registration statement and the prospectus used in connection therewith as may be necessary to keep such registration statement effective and to comply with the provisions of the Securities Act with respect to the disposition of all Registrable Securities until the earlier of (i) such time as all of such Registrable Securities have been disposed of in accordance with the intended methods of disposition set forth in such registration statement and (ii) the expiration of the 90-day period after such registration statement becomes effective; provided, that, such 90-day period shall be extended for such number of days that equals the number of days elapsing from (x) the date the written notice contemplated by paragraph (f) below is given by MSCI to (y) the date on which MSCI delivers to the Holders of Registrable Securities the supplement or amendment contemplated by paragraph (f) below; (c) furnish to the Holders of Registrable Securities and to any underwriter of such Registrable Securities such number of conformed copies of such registration statement and of each such amendment and supplement thereto (in each case including all exhibits), such number of copies of the prospectus included in such registration statement (including each preliminary prospectus and any summary prospectus), in conformity with the requirements of the Securities Act, such documents incorporated by reference in such registration statement or prospectus, and such other documents, as the Holders of Registrable Securities or such underwriter may reasonably request, and a copy of any and all transmittal letters or other correspondence to or received from, the SEC or any other governmental agency or self-regulatory body or other body having jurisdiction (including any domestic or foreign securities exchange) relating to such offering; (d) use its reasonable best efforts to register or qualify all Registrable Securities covered by such registration statement under the securities or blue sky laws of such jurisdictions as the Holders of such Registrable Securities or any underwriter to such Registrable Securities shall request, and use its reasonable best efforts to obtain all appropriate registrations, permits and consents in connection therewith, and do any and all other acts and things which may be necessary or advisable to enable the Holders of Registrable Securities or any such underwriter to consummate the disposition in such jurisdictions of its Registrable Securities covered by such registration statement; provided, that, MSCI shall not for any such purpose be required to qualify generally to do business as a foreign corporation in any such jurisdiction wherein it is not so qualified or to consent to general service of process in any such jurisdiction; (e) (i) use its reasonable best efforts to furnish to each Holder of Registrable Securities included in such registration (each, a “Selling Holder”) and to any underwriter of such Registrable Securities an opinion of counsel for MSCI addressed to each Selling Holder and dated the date of the closing under the underwriting agreement (if any) (or if such offering is not underwritten, dated the effective date of the registration statement), and (ii) use its reasonable best efforts to furnish to each Selling Holder a “cold comfort” letter addressed to each Selling Holder and signed by the independent public accountants who have audited the financial statements of MSCI included in such registration statement, in each such case covering substantially the same matters with respect to such registration statement (and the prospectus included therein) as are customarily covered in opinions of issuer’s counsel and in accountants’ letters delivered to underwriters in underwritten public offerings of securities and such other matters as the Selling Holders may reasonably request and, in the case of such accountants’ letter, with respect to events subsequent to the date of such financial statements; (f) as promptly as practicable, notify the Selling Holders in writing (i) at any time when a prospectus relating to a registration pursuant to a Demand Registration or Piggyback Registration is required to be delivered under the Securities Act of the happening of any event as a result of which the prospectus included in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state any material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, and (ii) of any request by the SEC or any other regulatory body or other body having jurisdiction for any amendment of or supplement to any registration statement or other document relating to such offering, and in either such case, at the request of the Selling Holders prepare and furnish to the Selling Holders a reasonable number of copies of a supplement to or an amendment of such prospectus as may be necessary so that, as thereafter delivered to the purchasers of such Registrable Securities, such prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they are made, not misleading; (g) if reasonably requested by the lead or managing underwriters, use its reasonable best efforts to list all such Registrable Securities covered by such registration on each securities exchange on which the Class A Common Stock of MSCI is then listed; (h) to the extent reasonably requested by the lead or managing underwriters, send appropriate officers of MSCI to attend any “road shows” scheduled in connection with any such registration, with all out-of-pocket costs and expense incurred by MSCI or such officers in connection with such attendance to be paid by MSCI; and (i) so long as the board of directors of MSCI shall not have provided by resolution or resolutions that all or some of all classes or series of the stock of MSCI shall be represented by uncertificated shares, furnish for delivery in connection with the closing of any offering of Registrable Securities pursuant to a Demand Registration or Piggyback Registration unlegended certificates representing ownership of the Registrable Securities being sold in such denominations as shall be requested by the Selling Holders or the underwriters.

  • 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 Adviser will ensure that the Fund will at all times invest money from the Contracts in such a manner as to ensure that the Contracts will be treated as variable annuity contracts under the Internal Revenue Code and the regulations issued thereunder. Without limiting the scope of the foregoing, the Fund will comply with Section 817(h) of the Internal Revenue Code and Treasury Regulation 1.817-5, as amended from time to time, relating to the diversification requirements for variable annuity, endowment, or life insurance contracts and any amendments or other modifications to such Section or Regulation. 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 Fund so as to achieve compliance within the grace period afforded by Treasury Regulation 1.817-5. 6.2. The Fund represents that it is or will be qualified as a Regulated Investment Company under Subchapter M of the Internal Revenue Code, and that it will make every effort to maintain such qualification (under Subchapter M or any successor or similar provisions) and that it will notify the Company immediately upon having a reasonable basis for believing that it has ceased to so qualify or that it might not so qualify in the future. 6.3. The Company represents that the Contracts are currently, and at the time of issuance shall be, treated as life insurance or annuity insurance contracts, under applicable provisions of the Internal Revenue Code, and that it will make every effort to maintain such treatment, and that it will notify the Fund and the Distributor immediately upon having a reasonable basis for believing the Contracts have ceased to be so treated or that they might not be so treated in the future. The Company agrees that any prospectus offering a contract that is a "modified endowment contract" as that term is defined in Section 7702A of the Internal Revenue Code (or any successor or similar provision), shall identify such contract as a modified endowment contract.

  • 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 duly organized, validly existing and in good standing under the Laws of the State of Delaware. 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, except where the failure to be so licensed, qualified or in good standing would not have a Material Adverse Effect.

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