Quality Review and Approval definition

Quality Review and Approval means LONZA’s review and approval, by LONZA’s quality assurance department, of a Clinical Batch and the associated Batch Disposition Documentation.
Quality Review and Approval means CBSB’s review and approval, by CBSB’s quality assurance department, of a Batch of Drug Substance and the associated Batch Record, resulting in the issuance of Certificate of Compliance by CBSB.
Quality Review and Approval means Paragon’s review and approval, by Paragon’s quality assurance department, of a Production Run Batch and the associated Batch Documentation for accuracy and completeness.

Examples of Quality Review and Approval in a sentence

  • Drug Substance that has been fully manufactured as of the date of such termination, but for which Quality Review and Approval has not been completed, shall remain subject to the terms of this Agreement, and the Agreement shall continue to survive with respect to such Drug Substance.

  • LONZA shall provide PROTEON’s quality assurance department with copies of completed Batch Disposition Documentation, and shall endeavor to do so within ten (10) Business Days of Quality Review and Approval.

  • Tercica’s disposition and release will be independent of CBSB’s Quality Review and Approval.

  • A Certificate of Compliance (COC), copies of completed Batch Records, Deviations and ICARs, and any applicable Manufacturing Documentation shall be provided to Tercica by CBSB within [*] after CBSB’s Quality Review and Approval of the Batch is completed.

  • For the avoidance of doubt, the [*] period for reporting [*] set forth above shall not be tolled nor extended in the event that Tercica requests that CBSB store Drug Substance beyond the Delivery Date or the date on which a given Batch has completed Quality Review and Approval and is made available for delivery to the Designated Carrier, as the case may be.

  • Actions taken to investigate the failure and to justify the CBSB’s Quality Review and Approval of the Batch of Drug Substance must be fully documented.

  • Following Quality Review and Approval and on or before the respective Delivery Date, CBSB shall make each Batch available to the Designated Carrier at CBSB’s Facility in * This provision is the subject of a Confidential Treatment Request.

  • Texas Commission on Environmental Quality Review and Approval The type and level of TCEQ administrative review and approval of proposed water transfers can directly impact water marketing because it can increase transfer transaction costs.

  • Within [*] days following completion of the Quality Review and Approval for each Batch, but in any event by not later than the Delivery Date, CBSB shall provide Tercica with a copy of all applicable Batch Records, which records shall be in CBSB’s standard formats unless otherwise mutually agreed to by the Parties.

  • Drug Substance that has been fully-manufactured as of the date of termination, but for which Quality Review and Approval has not been completed, shall remain subject to the terms of this Agreement, and the Agreement shall continue to survive with respect to such Drug Substance.

Related to Quality Review and Approval

  • Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.

  • Quality system means documented organizational procedures and policies: internal audits of those policies and procedures: management review and recommendation for quality improvement.”

  • Quality improvement organization or “QIO” shall mean the organization that performs medical peer review of Medicaid claims, including review of validity of hospital diagnosis and procedure coding information; completeness, adequacy and quality of care; appropriateness of admission, discharge and transfer; and appropriateness of prospective payment outlier cases. These activities undertaken by the QIO may be included in a contractual relationship with the Iowa Medicaid enterprise.

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Utilization review plan or "plan" means a written procedure for performing review.

  • Review Criteria has the meaning assigned to that term in Section 12.02(b)(i).

  • Expedited review means an examination, in accordance with

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Quality Improvement means a focus on activities to improve performance above minimum standards and reasonably expected levels of performance, quality and practice.

  • Utilization review organization means an entity that conducts utilization review, other than a health carrier performing a review for its own health plans.

  • Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;

  • Peer review means evaluation of professional services rendered by a professional practitioner.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Notification center means an organization whose membership is open to all operators of

  • QA means Quality Assurance.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • Quality Assurance means a systematic procedure for assessing the effectiveness, efficiency, and appropriateness of services.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.