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 Records, resulting in the issuance of a 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.

  • CBSB has the responsibility to ship the product to Tercica, or such other location as specified in writing by Tercica, after CBSB Quality Review and Approval.

  • 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.

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

  • CBSB will utilize a documented system of procedures for the control of changes to Raw Materials, Resins, packaging materials, Equipment, Master Production Records, the Manufacturing Process, sampling, test methods, and CBSB Quality Review and Approval requirements.

  • Depending on the outcome of that conversation, staff can develop a plan to assist development of those parcels.

  • 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.

  • Within [*] days following completion of Quality Review and Approval for a Batch, unless otherwise agreed by Tercica, but in any event by not later [*], CBSB shall furnish to Tercica a Certificate of Compliance and a summary (in a format to be agreed upon by Tercica and * This provision is the subject of a Confidential Treatment Request.

  • Accordingly, any claim that the Court lacked authority to approve the settlement or issue the Order approving the settlement because the case was closed should have been made at the time the Agreement was submitted to the Court-not29 years after the event.

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.

  • Drug utilization review means an evaluation of a prescription drug order and patient records for

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

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Summary Subcontract Report (SSR) Coordinator, as used in this clause, means the individual at the department or agency level who is registered in eSRS and is responsible for acknowledging or rejecting SSRs in eSRS for the department or agency.

  • 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 benefit 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 of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country 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.