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. 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. 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 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 a. Contractor shall evaluate the following physical characteristics of each individual seed lot:
(1) Number of bushels processed.
(2) Total weight measured in pounds (or grams).
(3) Weight of 100 seeds measured in pounds to at least three decimal points or grams to at least two decimal points (i.e. 1/100 gram precision).
(4) Percent filled seed determined by X-ray or cut test.
(5) Percent purity.
b. Test samples shall be randomly drawn from each seed lot. In the event that an individual seed lot has been processed in more than one batch, it shall be combined into a single lot before testing, packaging, and shipping.
c. Percent filled seed shall be determined by taking an X-ray image or cut test of a random sample of not less than 100 seeds per lot. Seeds which are unfilled or which contain evidence of insects shall be marked on each image or noted. Contractor shall deliver the X-ray images or cut test records to Agency when processed seed is delivered. The X-ray images shall be of sufficient quality to clearly show that each seed is filled, unfilled, or occupied by insect larvae.
d. Contractor shall submit the data to Agency in a Microsoft Excel spreadsheet format provided by Agency. Each row shall correspond to an individual seed lot. Agency will provide any additional instructions necessary to identify individual seed lots in the computer records.
Testing and Documentation. Promptly following each manufacturing run, Neos shall (a) test each lot of finished Product in accordance with the Specifications; and (b) certify within a commercially reasonable period of lot release that in all material respects each lot of finished Product: (i) shall conform with all applicable Regulations, (ii) was produced and tested in accordance with the Specifications, (iii) is in compliance with cGMP requirements, and (iv) complies with any other regulatory documents that contain manufacturing procedures agreed upon in writing between the Parties. Neos shall retain all relevant records pertaining thereto as may be required by GMP and other applicable laws.
Testing and Documentation. I3 shall certify monthly in writing, to NeoRx's reasonable satisfaction, that each Batch was produced and tested in compliance with (i) the Requirements, (ii) cGMP requirements, (iii) the IND or NDA (whichever is applicable) relevant to the Product, and (iv) all other applicable regulatory documents, in accordance with procedures agreed between I3 and NeoRx. The tests and analyses provided in the Requirements and the written certification referenced therein may be amended from time to time by mutual written consent of the parties. I3 shall also provide to NeoRx a Certificate of Analysis for each Clinical Batch that I3 processes.
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:
(i) the Specifications; and
(ii) all applicable laws, rules and regulations of Germany, the European Union and the United States, and in accordance with procedures agreed between Novoste and QSA. The tests and analyses provided in the Specifications as well as the nature and form of written certification may be amended from time to time only by mutual -------------------------------------------------------------------------------- Confidential treatment has been requested for portions of this page of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as "XXXXX". The portions omitted have been filed separately with the Securities and Exchange Commission pursuant to such request for confidential treatment. written consent of the Parties.
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. 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.
