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
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. 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. 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.
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. Quality Agreement: Page 5 [ * ] = 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.
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.
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.
