Testing and Documentation. Nordion shall maintain production records and BLSI shall have access to such records in order to determine that each Batch was produced and tested in compliance with the Specifications and cGMP requirements. The tests and analyses provided in the Specifications as well as the nature and form of records may be amended by Nordion from time to time, subject to mutual agreement and based upon an explanation of such changes provided to BLSI by Nordion.
Testing and Documentation. With each lot of Products manufactured by GBI, GBI shall supply to ATS documentation certifying in writing that each shipment of Products complies with (i) the then current Specifications and with the testing procedures described therein; and (ii) all other documentation agreed to by ATS and GBI.
Testing and Documentation. Nordion shall maintain accurate and complete production records with respect to the Process, Batches and shipments and Molecular Insight Pharmaceuticals shall have access to such records in order to determine that each Batch was produced and tested in compliance with the Specifications and cGMP requirements. The tests and analyses provided in the Specifications as well as the nature and form of records may be amended by Nordion from time to time, subject to the consent of Molecular Insight Pharmaceuticals, which shall not be unreasonably withheld after Nordion shall have delivered to Molecular Insight Pharmaceuticals, in writing, an explanation of such changes and why they are necessary or advisable.
Testing and Documentation. Prior to conducting any tests Contractor must provide the CHP Area Coordinator detailed test procedures for review and approval. Documentation of all test results must be provided to the CHP Area Coordinator for review and approval. System documentation must incorporate test results for ongoing maintenance and performance measurements.
Testing and Documentation a. Contractor shall evaluate the following physical characteristics of each individual seed lot:
Testing and Documentation. Promptly following each manufacturing run, Manufacturer shall (a) test each lot of finished Product in accordance with Parties’ agreed upon written Product Specifications; and (b) certify within a commercially reasonable period of lot release that: (i) each lot of finished Product shall conform with all Regulations of all applicable Federal or State Regulatory Authorities, (ii) each lot was produced and tested in accordance with the Specifications, (iii) each lot is in compliance with cGMP requirements and other applicable documents including the [***] and DMF for Product, and (iv) each lot complies with any other regulatory documents that contain procedures agreed upon in writing between the Parties. Manufacturer shall retain all relevant records pertaining thereto as may be required by GMP and other applicable Laws.
Testing and Documentation. Supplier shall test all Product to ensure compliance with the applicable Specifications in accordance with the Quality Agreement and pursuant to any changes thereof if such may be forthcoming due to any regulatory source(s). Copies of all documentation and test results, including batch records, certificate of analysis, standard operating procedures, laboratory assay methods, deviation and investigation reports, appropriately signed, as are necessary to demonstrate Supplier’s cGMP compliance shall be provided to Customer in accordance with the Quality Agreement.
Testing and Documentation. Nordion shall certify in writing, to Coulxxx'x xxxsonable satisfaction, that each Batch of Labelled Drug was produced and tested in compliance with (i) the Specifications, (ii) cGMP requirements, (iii) the IND or BLA (whichever is applicable) relevant to the Labelled Drug, and (iv) all other applicable regulatory documents, in accordance with procedures agreed between Coulxxx xxx Nordion. The tests and analyses provided in the Specifications and the written certification referenced therein may be amended from time to time by mutual written consent of the Parties.
Testing and Documentation. QSA shall certify in writing, to Novoste, and shall provide backup evidence as requested, that each Batch of Source Trains was produced and tested in compliance with:
Testing and Documentation. I3 shall certify in writing that each pack of Gemstones was Processed and tested in compliance with (i) the Requirements, (ii) all applicable regulatory documents, and (iii) in accordance with procedures agreed between I3 and QTI. The test and analysis provided in the Requirements and the written certification referenced therein may be amended from time to time with the mutual consent of the parties. Such consent shall be set forth in writing.
