In-Process and Finished Product Testing. All testing must be done in accordance with Exhibit E and under cGMP guidelines. TransMedics may perform confirmatory testing during the initial release of the PRODUCTS. Periodically thereafter, TransMedics may test material to confirm the Fresenius data.
In-Process and Finished Product Testing. 8.2.1 Raw Materials and packaging components
8.2.1.1 BIRI will ensure that all materials used are in compliance with the compendial and/or approved Methods and Specifications.
8.2.1.2 BIRI will perform all in-process and finished Product testing using the Specifications, finished Product attribute Acceptable Quality Level ("AQL"), and Methods of analysis approved by Xanodyne's Corporate Quality Assurance and other applicable licenses.
In-Process and Finished Product Testing. Transfer of Methods. A method transfer of any test method developed by AMAG will be completed prior to DPI’s dispositioning of Products, utilizing the transferred method(s), for release by AMAG. AMAG will work collaboratively with DPI to transfer any methods required by DPI.
In-Process and Finished Product Testing. Grifols will perform in-process and finished Product testing, including sterility, using the approved Specifications and validated or otherwise qualified methods of analysis as provided in the approved Drug Application and the Quality Agreement.
In-Process and Finished Product Testing. 6.2.1 A method transfer of any validated test method developed by ORPHAN will be completed prior to product release by LONZA.
6.2.2 LONZA will perform all in-process and finished product testing using approved specifications and methods of analysis. Laboratory notebook pages and representative sample chromatograms can be reviewed on LONZA’s site by ORPHAN.
6.2.3 A LONZA Qualified Person/QA Representative will sign a Certificate of Conformity confirming that the lots produced in a campaign have been manufactured, packaged, tested, and meets the requirements of the Master Batch Record and Drug Product Specification. The current release documentation information can be found in Appendix III.
6.2.4 Any reference standards that are supplied by ORPHAN or its Affliates must be accompanied by a COA listing the expiration date and any correction factors that need to be applied.
6.2.5 ORPHAN may perform testing to confirm the LONZA data. ORPHAN may perform confirmatory testing during the initial term of this Agreement to validate the LONZA data. Periodically thereafter, ORPHAN may test material to confirm the LONZA data. Dispute resolutions in conflicting test data will be handled according to the provisions of Section 9.
6.2.6 ORPHAN may perform release testing at a contract laboratory. Copies of all related documentation will be provided to LONZA upon request to support final disposition by LONZA.
In-Process and Finished Product Testing. All testing must be done in accordance with the NDA and under cGMP guidelines. At the completion of each packaging operation (including partial sublot packaging) Enzon will provide SkyePharma with one packaged unit of PRODUCTS for the purposes of identity testing of the contents to assure correct labeling. SkyePharma will provide the results of the identity test for inclusion in the Enzon labeling and packing records.
In-Process and Finished Product Testing. 9.2.1 Raw Materials and packaging components JB Labs will ensure that all materials used are in compliance with the compendial and/or approved Methods and Specifications.
9.2.2 JB Labs will perform all in-process and finished Product testing using the Specifications, finished Product attribute Acceptable Quality Level ("AQL"), and Methods of analysis listed in the release documentation list provided and approved by Xanodyne's Corporate Quality Assurance. JB Labs may subcontract testing in accordance with section 11.4.4.
In-Process and Finished Product Testing. 7.4.1 PYRAMID will perform in-process and finished product testing as directed by XERIS using approved XERIS Product Specifications and validated, or otherwise verified, Test Methods.
7.4.2 A Certificate of Analysis, confirming that the Product has been Produced and tested in accordance with the Product Specifications, will be issued by PYRAMID, XERIS or XERIS designated laboratory.
7.4.3 XERIS may perform testing at its cost to confirm or supplement the PYRAMID data. XERIS may perform confirmatory testing to validate the PYRAMID data. Periodically thereafter, XERIS may test material to confirm the PYRAMID data. Resolution of disagreements regarding conflicting test data will be handled per Article 10.0.
In-Process and Finished Product Testing. 9.2.1 Raw Materials and packaging components Patheon will ensure that all materials used are in compliance with the compendial and/or approved Methods and Specifications.
In-Process and Finished Product Testing. 6.2.1 A method transfer of any validated test method developed by ORPHAN will be completed prior to product release by LONZA. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
6.2.2 LONZA will perform all in-process and finished product testing using approved specifications and methods of analysis. Laboratory notebook pages and representative sample chromatograms can be reviewed on LONZA’s site by ORPHAN.
6.2.3 A LONZA Qualified Person/QA Representative will sign a Certificate of Conformity confirming that the lots produced in a campaign have been manufactured, packaged, tested, and meets the requirements of the Master Batch Record and Drug Product Specification. The current release documentation information can be found in Appendix III.
6.2.4 Any reference standards that are supplied by ORPHAN or its Affiliates must be accompanied by a COA listing the expiration date and any correction factors that need to be applied.
6.2.5 ORPHAN may perform testing to confirm the LONZA data. ORPHAN may perform confirmatory testing during the initial term of this Agreement to validate the LONZA data. Periodically thereafter, ORPHAN may test material to confirm the LONZA data. Dispute resolutions in conflicting test data will be handled according to the provisions of Section 9.
6.2.6 ORPHAN may perform release testing at a contract laboratory. Copies of all related documentation will be provided to LONZA upon request to support final disposition by LONZA.
