Certificate of Analysis and Certificate of Compliance Sample Clauses

Certificate of Analysis and Certificate of Compliance. A Certificate of Analysis and Certificate of Compliance must be provided to Buyer with each shipment.
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Certificate of Analysis and Certificate of Compliance. Seller will produce a Certificate of Analysis (C of A) confirming that the Products have been tested, and meet the registered specifications. Test specifications and test results must be included for each test in accordance with Exhibit A of the Agreement. Seller will also provide a Certificate of Compliance (C of C) stating the Products has been manufactured in accordance with the approved batch record and list all deviations and investigations related to the lot. The C of A and C of C may be combined into a single document provided all required information is contained therein. This document shall accompany each batch shipped from Seller.
Certificate of Analysis and Certificate of Compliance. 4.1 Certificate of Analysis Xxxxxx will maintain Certificates of Analysis (“COA”) for each batch of Product delivered, and will make such COAs available to BioTE upon request. In accordance with 21 CFR § 111.75, BioTE will rely on the information provided in the COA provided that: (a) Xxxxxx qualifies the supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations; (b) The COA includes a description of the test or examination method(s) used, label claim specifications, and actual results of the tests or examinations; (c) Xxxxxx maintains documentation of how Xxxxxx qualified the supplier, and forwards such documentation to BioTE upon BioTE’s request; (d) Xxxxxx periodically re-confirms the supplier’s COA; and (e) Xxxxxx’x quality control personnel reviews and approves the documentation setting forth the basis for qualification (and re-qualification) of any supplier. The COA must specify the Product, specifications, including (if available) label claim, expiration date, and results for the particular lot, and when applicable will include test method reference and the signature of the person authorized to release the lot. Xxxxxx will provide copies of internal and external test data sheets and chromatograms for applicable analytical tests on request for investigations or as necessary. Xxxxxx will include with the COA any record of investigation report prepared in response to an unplanned deviation or out-of-specification test result.
Certificate of Analysis and Certificate of Compliance. Upon completion of the manufacture of each batch of Product, Alvotech will provide Alvogen with a Certificate of Analysis and a Certificate of Compliance confirming that the batch was manufactured in conformity with the applicable Specifications, cGMP and all Applicable Laws.

Related to Certificate of Analysis and Certificate of Compliance

  • Certificate of Analysis Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).

  • Certificate of Compliance The Servicer shall deliver to the Note Issuer, the Note Trustee, the Certificate Trustee and the Rating Agencies on or before March 31 of each year, commencing March 31, 2006 to and including the March 31 succeeding the Retirement of the Notes, an Officer’s Certificate substantially in the form of Exhibit A hereto (a “Certificate of Compliance”), stating that: (i) a review of the activities of the Servicer during the twelve months ended the preceding December 31 (or, in the case of the first Certificate of Compliance to be delivered on or before March 31, 2006, the period of time from the date of this Agreement until December 31, 2005) and of its performance under this Agreement has been made under such Responsible Officer’s supervision, and (ii) to the best of such Responsible Officer’s knowledge, based on such review, the Servicer has fulfilled all of its obligations under this Agreement in all material respects throughout such twelve months (or, in the case of the Certificate of Compliance to be delivered on or before March 31, 2006, the period of time from the date of this Agreement until December 31, 2005), or, if there has been a failure to fulfill any such obligation in any material respect, specifying each such failure known to such Responsible Officer and the nature and status thereof.

  • Annual Certificate of Compliance The Issuer will deliver to the Indenture Trustee within 90 days after the end of each year, starting in the year after the Closing Date, an Officer’s Certificate signed by a Responsible Person of the Issuer, stating that (a) a review of the Issuer’s activities and of its performance under this Indenture during the prior year has been made under a Responsible Person’s supervision and (b) to the Responsible Person’s knowledge, based on the review, the Issuer has fulfilled in all material respects its obligations under this Indenture throughout the prior year or, if there has been a failure to fulfill an obligation in any material respect, stating each failure known to the Responsible Person and the nature and status of the failure. A copy of the Officer’s Certificate may be obtained by any Noteholder or Person certifying it is a Note Owner by request to the Indenture Trustee at its Corporate Trust Office. The Issuer’s obligation to deliver an Officer’s Certificate under this Section 3.9 will terminate on the payment in full of the Notes.

  • Certificate of Completion The Interconnection Customer shall provide the EDC with a completed copy of the Interconnection Agreement Certificate of Completion, including evidence of the electrical inspection performed by the local authority having jurisdiction. The evidence of completion of the electrical inspection may be provided on inspection forms used by local inspecting authorities. The Interconnection request shall not be finally approved until the EDC’s representative signs the Interconnection Agreement Certificate of Completion.

  • Drug-Free Workplace Certification As required by Executive Order No. 90-5 dated April 12, 1990, issued by the Governor of Indiana, the Company hereby covenants and agrees to make a good faith effort to provide and maintain a drug-free workplace at the Project Location. The Company will give written notice to the IEDC within ten (10) days after receiving actual notice that the Company, or an employee of the Company in the State of Indiana, has been convicted of a criminal drug violation occurring in the workplace. False certification or violation of this certification may result in sanctions including, but not limited to, suspension of payments under the Agreement, termination of the Agreement and/or debarment of contracting opportunities with the State for up to three (3) years. In addition to the provisions of the above paragraph, if the total amount set forth in the Agreement is in excess of $25,000.00, the Company agrees that it will provide a drug-free workplace by: A. Publishing and providing to all of its employees a statement notifying them that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Company’s workplace, and specifying the actions that will be taken against employees for violations of such prohibition;

  • Statement of Compliance Contractor has, unless exempted, complied with the nondiscrimination program requirements. (Gov. Code §12990 (a-f) and CCR, Title 2, Section 11102) (Not applicable to public entities.)

  • Annual Statement of Compliance The Officer’s Certificate required to be delivered by the Issuing Entity, pursuant to Section 3.9 of the Indenture or the Officer’s Certificate required to be delivered by the Servicer pursuant to Section 4.01(a) of the Servicing Agreement, as applicable.

  • Certification of Compliance San Diego Municipal Code section 22.4225 requires each Bidder to fill out and file a living wage certification with the Living Wage Program Manager within thirty (30) days of Award of the Contract.

  • Escrow Format Specification Deposit’s Format. Registry objects, such as domains, contacts, name servers, registrars, etc. will be compiled into a file constructed as described in draft-xxxxx-xxxxxxx-registry-data-escrow, see Part A, Section 9, reference 1 of this Specification and draft-xxxxx-xxxxxxx-dnrd-objects-mapping, see Part A, Section 9, reference 2 of this Specification (collectively, the “DNDE Specification”). The DNDE Specification describes some elements as optional; Registry Operator will include those elements in the Deposits if they are available. If not already an RFC, Registry Operator will use the most recent draft version of the DNDE Specification available at the Effective Date. Registry Operator may at its election use newer versions of the DNDE Specification after the Effective Date. Once the DNDE Specification is published as an RFC, Registry Operator will implement that version of the DNDE Specification, no later than one hundred eighty (180) calendar days after. UTF-8 character encoding will be used.

  • Form of Compliance Certificate A review of the activities of the Borrower during such fiscal period has been made under the supervision of the undersigned with a view to determining whether during such fiscal period the Borrower performed and observed all its Obligations under the Loan Documents, and

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