Quality Unit definition

Quality Unit means collectively the Supplier Quality Assurance, Quality Control and Regulatory Affairs Departments.
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Quality Unit means the group of persons responsible for the quality and safety relating to the Product;
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Quality Unit means an organizational unit independent of production which fulfils both Quality Assurance and quality control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.
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Examples of Quality Unit in a sentence

  • Responsible Person: The person(s) within the Quality Unit at the supplier who is accountable for releasing batches of product.

  • Audits of [+] facilities, [+] laboratories, and related study data will be conducted by experienced auditors from the Quality Unit.

  • Certificate of Conformance — A document identified as such, provided by the Supplier and signed by a nominated representative of its Quality Unit; or produced by a computer system which provides a degree of control equivalent to that given by a signature, which certifies that each batch of Product was produced and -tested in compliance with the agreed specifications, cGMP, and the relevant pharmacopoeial monographs, as applicable.

  • Responsible Person — The person(s) within the Quality Unit at the Supplier who is accountable for the release of batches of product.

  • Significant changes in these manufacturing practices will be communicated to Customer’s Quality Unit in writing for assessment of impact and approval before implementation.

  • Provider agrees to identify a representative of their independent Quality Assurance unit, as applicable, to act as a liaison to a representative of Synthorx Quality Unit.

  • Quality Unit The organizational entity, at either GNE or SurModics, that has been identified to the other party as having responsibility for activities or approvals described in this Quality Agreement.

  • Manager shall conduct a Quality Unit Survey of each unit one time per year at a rate of $95 per report.

  • Any shipment of product from C*P which is Unapproved or under Quarantine requires prior written consent by the ORPHAN’S Quality Unit.

  • After review by Amcis Quality Unit, the executed batch record will be forwarded to Salmedix for review.


More Definitions of Quality Unit

Quality Unit means collectively the PPL-SD Quality Assurance and Quality Control Departments.
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Quality Unit means the department within ARIAD, MERCK or their respective Approved Manufacturers’ organization that is responsible for implementation of the Quality Assurance Systems.
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