Certificates of Analysis and Compliance Clause Samples

The 'Certificates of Analysis and Compliance' clause requires suppliers or manufacturers to provide formal documentation verifying that products meet specified quality and regulatory standards. Typically, this involves delivering a certificate with each shipment that details test results, batch numbers, and confirmation of compliance with agreed-upon specifications or legal requirements. This clause ensures that buyers receive products that are safe, consistent, and legally compliant, thereby reducing the risk of defective or non-conforming goods entering the supply chain.
POPULAR SAMPLE Copied 1 times
Certificates of Analysis and Compliance. Eagle shall, or shall cause the Third Party Manufacturer, to provide MDCO with a copy of the certificate of analysis, the materials safety data sheet and a certificate of compliance (together, the “Certificates”), with, or at the same time of, each delivery of Finished Product supplied hereunder. In the event MDCO requires additional documentation due to a change in Applicable Laws or Regulatory Approvals, without which the release into commerce and selling of Product in the Field in the Territory under any Regulatory Approval would be impossible or impracticable (hereinafter “Additional Documentation”), Eagle shall, or shall use Commercially Reasonable Efforts to cause its Third Party Manufacturer to, supply such documentation with each delivery of Product. Subject to any variations agreed to in the Quality Agreement, such Certificates shall certify, with respect to each shipment and Batch (identified by Batch number): (i) the quantity of the shipment, (ii) that the Product delivered conforms to, and was handled in compliance with, the Product Specifications, (iii) that the Product was Manufactured in accordance with cGMP and all other Applicable Laws and any applicable Regulatory Approvals, as well as any further information required by the relevant regulatory authorities that MDCO may have previously notified Eagle is necessary, (iv) confirmation that all quality controls tests on the active pharmaceutical ingredients, excipients and other Product and Finished Product components, Labeling and Packaging were conducted in accordance with all Applicable Laws and applicable Regulatory Approvals, and the results thereof, and (v) confirmation that each such Batch has been released for commercial sale by the Third Party Manufacturer in accordance with all Applicable Laws and applicable Regulatory Approvals, and (vi) such information as pharmaceutical manufacturers generally include in certifications similar to the Certificates, including the release tests performed by Eagle or the Third Party Manufacturer and the results of those tests.
View SourceView Similar (2)
Certificates of Analysis and Compliance. Lonza shall deliver to Customer the Certificate of Analysis, Certificate of Compliance and such other documentation as is reasonably required and/or requested by Customer to meet all applicable regulatory requirements of the Governmental Authorities not later than the date of Release of such cGMP Batches; provided that Lonza may, upon notice to Customer, supply certain trade secret information, such as Lonza’s media and feed formulation, directly to the relevant Governmental Authority instead of supplying it to Customer.
View SourceView Similar (2)
Certificates of Analysis and Compliance. 11 CONTACTS..................................................................... 11
View Source
Certificates of Analysis and Compliance. NovaDel shall provide appropriate certification that the Licensed Product supplied meets specifications, and other applicable quality standards, as determined by the parties in the Quality Agreement, to BioAlliance with each shipment of Licensed Product supplied hereunder. In the event BioAlliance requires additional documentation from a Manufacturer (whether due to a change in the applicable laws, rules or regulations or in a Regulatory Approval for Licensed Product) to Exploit Licensed Product in the Territory under any Regulatory Approval, NovaDel will use Commercially Reasonable Efforts to supply such documentation with each shipment of Licensed Product. Such certificates shall certify with respect to each shipment and batch (identified by batch number) (i) the quantity of the shipment, (ii) that the Licensed Product delivered conforms to the Specifications and (iii) that the Licensed Product was Manufactured in accordance with *** Portion for which confidential treatment requested.
View Source
Certificates of Analysis and Compliance. 4.1 Schering requires a Certificate of Analysis (COA) from Millennium to accompany each lot of delivered Product. The COA must list the Product's Specifications, test results obtained for the particular lot, test method reference, and the signature of the person authorized to release the lot to Schering. In addition, the location where the Product was manufactured and tested, if different from that on the letter head, must be identified. A Certificate of Compliance (COC) that states the lot was Manufactured under cGMP conditions must accompany the lot or the declaration may appear on the COA. 4.2 Schering may request copies of batch documentation including the executed batch record and associated deviations and investigations. 4.3 Millennium shall have a program in place to qualify and assess periodically the performance of its Authorized Contractors, regardless of whether Millennium receives a COA/COC for each delivery of material. 4.4 All raw materials must comply with TSE (transmissible spongiform encephalopathy)/ BSE (bovine spongiform encephalography) guideline EMEA /410/01 Rev. 1) and Residual Solvent guideline (ICH Topic QC3, Impurities: Residual Solvents). In addition, raw materials should be traceable to the original supplier.
View Source
Certificates of Analysis and Compliance. ▇▇▇ shall deliver to Pharmion, together with each delivery of each batch of Product, the corresponding Certificate of Compliance and the Certificate of Analysis relating to such batch. The Certificate of Analysis shall give full analytical results with respect to regulatory Specifications for each batch. The Certificate of Compliance will confirm that the Product has been made and tested in accordance with the master batch record, the Specifications and the test methods specified in the NDA. ▇▇▇ shall promptly inform Pharmion of significant events and/or results including, but not limited to, quality incidents and batch deviations which may have occurred during the Manufacturing and/or Packing and which might affect the quality of the Product.
View Source
Certificates of Analysis and Compliance. Schering shall deliver to Pharmion, together with each delivery of each batch of Product, the corresponding Certificate of Compliance and the Certificate of Analysis relating to such batch. The Certificate of Analysis shall give full analytical results with respect to regulatory Specifications for each batch. The Qualified Person working for the Manufacturer shall sign a Certificate of Compliance confirming that the Product has been made and tested in accordance with the master batch record, the Specifications and the test methods specified in the approved registration dossier. Schering shall promptly inform Pharmion of significant events and/or results including, but not limited to, quality incidents and batch deviations which may have occurred during the Manufacturing and/or Packing and which might affect the quality of the Product.
View Source
Certificates of Analysis and Compliance. Alfacell shall provide Par with a copy of the certificate of analysis and a certificate of compliance (together, the “Certificates”), with, or at the same time of, each delivery of Product supplied hereunder. In the event Par requires additional documentation due to a change in the law or a Regulatory Approval without which the release into commerce and selling of Product in the Field in the Territory under any Regulatory Approval would be impossible or impracticable, Alfacell will use Commercially Reasonable Efforts to supply (unless such documentation is required from all manufacturers of pharmaceutical products, in which case Alfacell shall supply or cause its Third Party Manufacturer to supply) such documentation with each delivery of Product. Subject to variations agreed to in the Quality Agreement, such Certificates shall certify, with respect to each shipment and batch (identified by batch number): (i) the quantity of the shipment, (ii) that the Product delivered conforms to, and was handled in compliance with, the Product Specifications and (iii) that the Product was Manufactured in accordance with cGMP and any applicable Regulatory Approval, as well as any further information required by the relevant regulatory authorities that Par may have previously notified Alfacell is necessary. Par shall be under no obligation to accept any shipment of Product without the accompanying Certificates.
View Source

Related to Certificates of Analysis and Compliance

  • Certificates of Compliance The Company shall provide, from time to time upon request of the Dealer Manager, certificates of its chief executive officer and chief financial officer of compliance by the Company of the requirements of this Agreement.

  • S▇▇▇▇▇▇▇-▇▇▇▇▇ Compliance As soon as it is legally required to do so, the Company shall take all actions necessary to obtain and thereafter maintain material compliance with each applicable provision of the S▇▇▇▇▇▇▇-▇▇▇▇▇ Act of 2002 and the rules and regulations promulgated thereunder and related or similar rules and regulations promulgated by any other governmental or self-regulatory entity or agency with jurisdiction over the Company.

  • Contractor Compliance Contractor represents and warrants to pay, at its sole expense, for all applicable permits, licenses, tariffs, tolls and fees to give all notices and comply with all laws, ordinances, rules and regulations of any governmental entity in conjunction with the performance of obligations under the Contract. Prior to award and during the Contract term and any renewals thereof, Contractor must establish to the satisfaction of the Commissioner that it meets or exceeds all requirements of the Bid/Contract and any applicable laws, including but not limited to, permits, insurance coverage, licensing, proof of coverage for worker’s compensation, and shall provide such proof as required by the Commissioner. Failure to do so may constitute grounds for the Commissioner to cancel or suspend this Contract, in whole or in part, or to take any other action deemed necessary by the Commissioner.

  • Documentation and compliance (a) The data importer shall promptly and adequately deal with enquiries from the data exporter that relate to the processing under these Clauses. (b) The Parties shall be able to demonstrate compliance with these Clauses. In particular, the data importer shall keep appropriate documentation on the processing activities carried out on behalf of the data exporter. (c) The data importer shall make available to the data exporter all information necessary to demonstrate compliance with the obligations set out in these Clauses and at the data exporter’s request, allow for and contribute to audits of the processing activities covered by these Clauses, at reasonable intervals or if there are indications of non-compliance. In deciding on a review or audit, the data exporter may take into account relevant certifications held by the data importer.

  • ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Compliance As soon as it is legally required to do so, the Company shall take all actions necessary to obtain and thereafter maintain material compliance with each applicable provision of the ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Act of 2002 and the rules and regulations promulgated thereunder and related or similar rules and regulations promulgated by any other governmental or self-regulatory entity or agency with jurisdiction over the Company.