Laboratory Qualification. Fresenius is responsible for ensuring that all laboratories are in compliance with applicable cGMP guidelines. In addition, if analytical work is subcontracted by Fresenius, then Fresenius will perform an audit on such contract laboratories to be used for analytical testing. Fresenius will be responsible for ensuring that the vendors are practicing within cGMP compliance. In the event that TransMedics Quality Assurance laboratories will perform analytical testing of a PRODUCT, Fresenius will cooperate in the technology transfer to such laboratory, and will confirm that the technology transfer has been successful and the laboratory is capable of reproducing Fresenius laboratory results.
Laboratory Qualification. DSM is responsible for ensuring that all laboratories are in compliance with applicable cGMP’s guidelines. If analytical work is performed at DSM then Barrier will also provide any existing analytical documentation to assist in methods transfer or methods validation. In addition, if analytical work is not performed at the Greenville site, DSM may elect to perform an audit on vendors to be used for analytical testing. DSM will be responsible for insuring that any vendor selected by DSM is practicing within cGMP compliance. Vendors selected by Barrier must be certified by Barrier and acceptable per cGMP.
Laboratory Qualification. Nastech is responsible for ensuring that all laboratories used by Nastech in connection with the Product are in compliance with applicable cGMP and cGLP (current Good Laboratory Procedures) guidelines. Nastech will provide LICENSEE with a certification that the selected vendor is meeting cGMPs/cGLPs. Vendors selected by LICENSEE must be certified by LICENSEE and acceptable per cGMPs and cGLPs.
Laboratory Qualification. 7.2.1 Avecia is responsible for ensuring that all QC laboratories are in compliance with FDA cGMP regulations and are appropriately qualified in all of the methodology associated with Nuvelo’s APIs.
Laboratory Qualification. DPI is responsible for ensuring that all laboratories are in compliance with applicable cGMP guidelines. If analytical work is performed at DPI, then AMAG will also provide any existing analytical documentation to assist in methods transfer or methods validation. In addition, if analytical work is not performed at the Greenville site, DPI may elect to perform an audit on vendors to be used for analytical testing. DPI will be responsible for insuring that any vendor selected by DPI fully complies with cGMP requirements. Vendors selected by AMAG must be certified by AMAG and acceptable per cGMP.
Laboratory Qualification. 7.2.1 Avecia is responsible for ensuring that all QC laboratories are in compliance with cGMP’s and are qualified in all of the methodology associated with Stressgen API.
Laboratory Qualification. ORPHAN is responsible for ensuring that all laboratories and laboratory equipment are in compliance with applicable cGMP's guidelines and particularly 21 CFR Part 11. ORPHAN will provide to CELLTECH support in the form of existing analytical documentation to assist in methods transfer or methods validation.
Laboratory Qualification. SkyePharma is responsible for ensuring that all laboratories are in compliance with applicable cGMP guidelines. If analytical work is subcontracted by SkyePharma, SkyePharma will be responsible for the technology transfer to such laboratory and will confirm that the technology transfer had been successful, that the laboratory is capable of reproducing SkyePharma laboratory results and that the laboratory is in compliance with cGMP. SkyePharma will perform an audit on such vendors to be used for analytical testing. SkyePharma will be responsible for ensuring that the vendor is practicing within cGMP compliance. In the event that an ENZON quality control laboratory will perform analytical testing of a Product, SkyePharma will be responsible for the technology transfer to such laboratory and will confirm that the technology transfer has been successful and that the laboratory is capable of reproducing SkyePharma laboratory results.
Laboratory Qualification. Xxxxxx is responsible for ensuring that all laboratories are in compliance with cGMPs and are qualified in all of the methodology associated with the Product. If Product specific analytical work is performed at Xxxxxx then Halozyme will provide any relevant analytical documentation and training to assist in methods transfer or methods validation. Xxxxxx is responsible for third party laboratory qualification unless such laboratory is specified by Halozyme and assurance that analytical methods are validated or otherwise qualified.
Laboratory Qualification. ORGANICHEM is responsible for ensuring that any contract laboratories used are compliant with cGMPs and are qualified in all of the methodology associated with the API. If analytical work is performed at ORGANICHEM, then NEW RIVER will also provide any existing analytical documentation to assist in methods transfer or methods validation. ORGANICHEM will not use any validation protocol or issue a report unless NEW RIVER technical personnel have first reviewed and provided comment (as appropriate). NEW RIVER will review all protocols and reports [***] [***]. In addition, if analytical work is not performed at ORGANICHEM’s site, ORGANICHEM may elect to perform an audit on vendors to be used for analytical testing. Should ORGANICHEM decide to sub-contract out any analytical testing, prior approval from NEW RIVER QA or designee will be required.
