Batch certification Sample Clauses

Batch certification. 7.6.1. After detailed review of the batch documentation of each batch, GW is responsible to ensure that a Certificate of Compliance with GMP (CoC, confirmation statement) is included or attached to the CoA, Deviation Statement if applicable, that is signed by a Quality Assurance person (Qualified Person).
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Batch certification. Each batch exported will be accompanied by a batch certificate issued by the manufacturer ("self certification") after a full qualitative and quantitative analysis of all active constituents to ensure that the quality of the products complies with the requirements of the Marketing Authorization/Product Approval. When issuing this certificate, the manufacturer will take into account the provisions of the current WHO certification scheme on the quality of medicinal products/drugs moving in international commerce. This certificate will attest that the batch meets the specifications and has been manufactured in accordance with the relevant Marketing Authorization/Product Approval, detailing the specifications of the product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing and packaging records were reviewed and found in conformity with GMPs. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply. In the European Community the "qualified person" is referred to in Article 21 of Directive 75/319/EEC, and in Canada, the nominated person responsible for manufacturing quality control is as specified in the Food and Drug Regulations, Division 2, Section C.02.014 (1).
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Batch certification. 4. Each batch exported shall be acc ompanied by a batch certificate prepared by the manufa cturer (self-certification) after a full qualita tive analysis, a quantitative analysis of all the active c onstituents and all the other tests or checks necessary to ensure the quality of the product in acc ordance with the requirements of the marketing authorization. This certificate shall attest that the batch meets its specifications and shall be kept by the importer of the batch. It will be made available upon request of the competent authority. When issuing a certificate, the manufa cturer shall take account of the provisions of the current WHO certification scheme on the quality of pharmaceutic al products moving in international commerce. The certificate will detail the agreed specifications of the product, the reference of the analytic al methods and the analytical results. It shall contain a statement that the batch processing and packaging rec ords were reviewed and found to be in conformity with GMP. The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Community the "qualified person" referre d to in Article 21 of Second Council Directive 75/319/EEC of 20 May 1975 on the approxim ation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. In Australia, the responsible persons are for manufa cturing quality control as specified in the Therapeutic Goods Regulation 19(b) under the Therapeutic Goods Xxx 0000.
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Batch certification. If required, upon reception of the above mentioned elements, CA shall perform the certification of the Product (or group of products included in the shipment) for the territory. Authorization to release product for the territory, sale should be provided directly and solely by CA. A certificate authorizing shipment to customer will be issued by CA.
Sample 1
Batch certification. Each batch exported will be accompanied by a batch certificate issued by the manufacturer ("self certification") after a full qualitative and quantitative analysis of all active constituents to ensure that the quality of the products complies with the requirements of the Marketing Authorisation / Product Approval. When issuing this certificate, the manufacturer will take into account the provisions of the current WHO certification scheme on the quality of medicinal products / drugs moving in international commerce. This certificate will attest that the batch meets the specifications and has been manufactured in accordance with the relevant Marketing Authorisation / Product Approval, detailing the specifications of the product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing and packaging records were reviewed and found in conformity with GMP. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply. In Switzerland the qualified person is referred to in article 10 of the IOCM-Manufacturing Directive (May 18, 1995, No. 241.11) and in articles 4 and 5 of the Ordinance on immunobiological products and in Canada, the nominated person responsible for manufacturing quality control is as specified in the Food and Drug Regulations, Division 2, Section C.02.014 1.
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Related to Batch certification

  • OFAC Certification Company certifies that (i) it is not acting on behalf of any person, group, entity, or nation named by any Executive Order or the United States Treasury Department, through its Office of Foreign Assets Control (“OFAC”) or otherwise, as a terrorist, “Specially Designated Nation”, “Blocked Person”, or other banned or blocked person, entity, nation, or transaction pursuant to any law, order, rule or regulation that is enforced or administered by OFAC or another department of the United States government, and (ii) Company is not engaged in this transaction on behalf of, or instigating or facilitating this transaction on behalf of, any such person, group, entity or nation.

  • Committee Certification As soon as reasonably practical following the end of the Performance Period, the Committee shall review the results for the Performance Period and certify those results in writing to the Board. No Performance Units or DERs shall be paid prior to the Committee’s certification. However, Committee certification shall not apply in the event of a Change of Control.

  • ERISA Certification The transferee of the Residual Interest delivers to the Indenture Trustee and the Owner Trustee a certification that it is not, and is not acting on behalf of or investing the assets of (i) an “employee benefit plan” (as defined in Section 3(3) of ERISA) that is subject to Title I of ERISA, (ii) a “plan” (as defined in Section 4975(e)(1) of the Code) that is subject to Section 4975 of the Code, (iii) an entity whose underlying assets include “plan assets” (within the meaning of Department of Labor Regulation 29 C.F.R. Section 2510.3-101 or otherwise under ERISA) by reason of the employee benefit plan’s or plan’s investment in the entity, or (iv) an employee benefit plan, plan or retirement arrangement that is subject to Similar Law; and

  • Annual Certification The Contractor is required to submit an annual certification demonstrating compliance with the Warranty of Security to the Department by December 31 of each Contract year.

  • Periodic Certification Each year, at the time of delivery of annual financial statements with respect to the preceding fiscal year pursuant to Section 5.01 of the Credit Agreement, the Borrower shall deliver to the Collateral Agent a certificate executed by a Financial Officer of the Borrower (a) setting forth the information required pursuant to this Section 2 of the Perfection Certificate or confirming that there has been no change in such information since the date of such certificate or the date of the most recent certificate delivered pursuant to this Section 4.02 and (b) certifying that all Uniform Commercial Code financing statements (including fixture filings, as applicable) or other appropriate filings, recordings or registrations, including all refilings, rerecordings and reregistrations, containing a description of the Collateral have been filed of record in each governmental, municipal or other appropriate office in each jurisdiction identified pursuant to clause (a) above to the extent necessary to protect and perfect the Security Interest for a period of not less than 18 months after the date of such certificate (except as noted therein with respect to any continuation statements to be filed within such period). Each certificate delivered pursuant to this Section 4.02 shall identify in the format of Schedule II, III, IV or V, as applicable, all Patents, Trademarks, Copyrights and Licenses of any Grantor in existence on the date thereof and not then listed on such Schedules or previously so identified to the Collateral Agent.

  • Tax Certifications If any interest in any Loan Document is transferred to any Transferee which is not incorporated under the laws of the United States or any State thereof, the transferor Lender shall cause such Transferee, concurrently with the effectiveness of such transfer, to comply with the provisions of Section 3.5(iv).

  • Xxxxxxxx-Xxxxx Certification Each Form 10-K with respect to the Trust shall include a Xxxxxxxx-Xxxxx Certification in the form attached to this Agreement as Exhibit X required to be included therewith pursuant to the Xxxxxxxx-Xxxxx Act. The Certificate Administrator, the Master Servicer, the Special Servicer, the Operating Advisor, the Asset Representations Reviewer (in the case of the Asset Representations Reviewer, solely with respect to reporting periods in which the Asset Representations Reviewer is required to deliver an Asset Review Report Summary), the Custodian and the Trustee shall provide (and (i) with respect to any Servicing Function Participant of such party that is a Mortgage Loan Seller Sub-Servicer, shall use commercially reasonable efforts to cause such Servicing Function Participant to provide, and (ii) with respect to any other Servicing Function Participant of such party (other than any party to this Agreement), shall cause such Servicing Function Participant to provide) to the Person who signs the Xxxxxxxx-Xxxxx Certification for the Trust or any Other Securitization Trust (the “Certifying Person”) no later than March 1 in the year immediately following the year as to which such Form 10-K relates or, if March 1 is not a Business Day, on the immediately following Business Day, a certification in the form attached to this Agreement as Exhibit Y-1, Exhibit Y-2, Exhibit Y-3, Exhibit Y-4, Exhibit Y-5, Exhibit Y-6, Exhibit Y-7 and Exhibit Y-8, as applicable, on which the Certifying Person, the entity for which the Certifying Person acts as an officer, and such entity’s officers, directors and Affiliates (collectively with the Certifying Person, “Certification Parties”) can reasonably rely. With respect to each Outside Serviced Mortgage Loan serviced under an Outside Servicing Agreement, the Certificate Administrator shall use commercially reasonable efforts to procure, and upon receipt deliver to the Certifying Person, a Xxxxxxxx-Xxxxx back-up certification similar in form and substance to the certifications referenced in the preceding sentence, from the related Outside Servicer, the related Outside Special Servicer, the related Outside Paying Agent and the related Outside Trustee. In the event any Reporting Servicer is terminated or resigns pursuant to the terms of this Agreement, or any applicable Sub-Servicing Agreement or primary servicing agreement, as the case may be, such Reporting Servicer shall provide a certification to the Certifying Person pursuant to this Section 10.06 with respect to the period of time it was subject to this Agreement or the applicable sub-servicing or primary servicing agreement, as the case may be.

  • Compliance Certification From time to time the Sub-Adviser shall provide such certifications with respect to Rule 38a-1 under the 1940 Act, as are reasonably requested by the Fund or the Manager. In addition, the Sub-Adviser will, from time to time, provide a written assessment of its compliance program in conformity with current industry standards that is reasonably acceptable to the Fund to enable the Fund to fulfill its obligations under Rule 38a-1 under the 1940 Act.

  • FIRPTA Certification The Company shall have delivered to Parent a statement issued and executed by the Company pursuant to and in compliance with Sections 1.897-2(h) and 1.1445-2(c) of the Treasury Regulations certifying that the Company Shares are not a “United States real property interests” within the meaning of the Code.

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