Qualification/Validation Clause Samples
Qualification/Validation. Equipment qualification, process validation, analytical methods validation and validation of computerized systems, if used, are in place and covered by Change Control. Validation documentation shall be available for review during an audit. On request, the Client will get copies or summaries from the process validation reports. Development (Early clinical phase) Supplier’s equipment qualification and Change Control process are in place. Verification of analytical methods for intended use (see Note).
Qualification/Validation. Centogene shall be responsible for the performance of all needed qualification and validation activities of the Facility, equipment and cleaning and maintenance processes employed in the manufacturing process of Contract DBS Test Kits in accordance with GMP, GLP, Applicable Laws, Standards and Regulatory Approvals.
Qualification/Validation. TANABE shall be responsible for ensuring that an appropriate qualification/validation data is generated for any changes in processes, test methods and SPECIFICATIONS. TANABE shall supply VIVUS with the proposed protocols for qualification/validation, in advance of work conducted, for VIVUS' approval which shall not be reasonably withheld or delayed. TANABE shall supply VIVUS with a copy of the qualification/validation report.
Qualification/Validation. 1.8.1 APO shall qualify and maintain, consistent with cGMP according to APO protocols and procedures, the facilities, utilities, and equipment required to support the MANUFACTURING of the PRODUCT.
1.8.2 APO shall qualify cleaning processes for shared equipment in the facility for MANUFACTURING the PRODUCT as per APO protocols and procedures.
1.8.3 As specifically contracted by GILEAD (i.e., under separate purchase orders), related APO PRODUCT qualification/validation results shall be assembled in a validation report(s) and provided to GILEAD for review and approval. APO shall maintain original documentation in its site files and provide GILEAD with copies of the approved protocol(s) and report(s).
Qualification/Validation. HOVIONE shall insure that equipment qualification, process validation, analytical methods validation and validation of computerized systems, if applicable, are in place and covered by change control. Validation documentation related to the process and/or analytical method validation shall be reviewed and approved by ACHAOGEN. On request, ACHAOGEN will get copies or summaries from the validation reports, as applicable.
Qualification/Validation. 5.1 Follows a written qualification master plan for the facilities, equipment/instruments, and computerized systems as appropriate. x
5.2 Follows a written validation master plan for related production and testing steps. x
5.3 Qualify all necessary all critical systems and equipment used for the manufacture and control of the contracted products. x
5.4 Allow viewing the qualification/validation documentation during an onsite audit. x