Laboratory Qualification Clause Samples
The Laboratory Qualification clause establishes the requirements and standards that a laboratory must meet to be considered eligible for performing specific tests or analyses under an agreement. Typically, this involves demonstrating compliance with industry certifications, maintaining proper equipment calibration, and ensuring staff are adequately trained. By setting these criteria, the clause ensures that only competent and reliable laboratories are used, thereby safeguarding the quality and integrity of test results and minimizing the risk of errors or disputes.
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. 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.
Laboratory Qualification. LONZA is responsible for ensuring that all laboratories are in compliance with applicable cGMP’s guidelines. If analytical work is performed at LONZA then ORPHAN 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 Conshohocken, Pennsylvania site, LONZA may elect to perform an audit on vendors to be used for analytical testing. LONZA will be responsible for insuring that the vendor is practicing within cGMP compliance.
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.
7.2.2 Avecia and Stressgen QA will agree responsibility for Validation Methodology. Validation methodology will be developed in compliance with ICH Q2A test on Validation of Analytical Procedures and ICH Q2B Validation of Analytical Procedures. If Stressgen QA provide Avecia with validated method then Avecia will only need to verify the methods.
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 FDA cGMP regulations and are appropriately qualified in all of the methodology associated with Nuvelo’s APIs.
7.2.2 Validation methodology will be developed in compliance with ICH Q2A Text on Validation of Analytical Procedures and ICH Q2B Validation of Analytical Procedures; Methodology. The degree of validation of methods will be agreed with Nuvelo according to the status of the API.
Laboratory Qualification. ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇ then Halozyme will provide any relevant analytical documentation and training to assist in methods transfer or methods validation. ▇▇▇▇▇▇ 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. PYRAMID is responsible for ensuring 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 PYRAMID, then XERIS will provide any relevant analytical documentation to assist in the methods transfer or methods validation. PYRAMID is responsible for third party laboratory qualification unless such laboratory is specified by XERIS. PYRAMID may be contracted to qualify third party laboratory at XERIS’ expense.
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.