Product Quality Review definition

Product Quality Review shall have the meaning ascribed thereto in Section 2.1(f);
Product Quality Review means regular, periodic or rolling quality reviews of all medicinal products, including export-only products, conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements.
Product Quality Review means the written review of manufacturing and quality assurance activities for Finished Product in a defined time period.

Examples of Product Quality Review in a sentence

  • Product quality review (PQR)PQR was performed according to an SOP.

  • For this provision parameters especially Primary RS, Product quality review, Analytical method/ process validation, (as per pharmacopoeial, ICH standards), building/machinaries qualification, F&D facility/capability, DMF of raw materials, ETP etc.

  • In considering patient perspective and experience, BioMarin suggests the FDA acknowledge the recruitment challenges for placebo-controlled trials in rare disease settings as well as the unwillingness and concerns of parents and caregivers in entering patients into placebo-controlled studies.

  • I had worn frilly and unglamorous dresses as an adolescent many times while being a bride’s maid.

  • Product quality review (PQR):The annual product quality review was performed according to the implemented procedure.

  • Product quality review (APQR)The SOP “Annual product quality review” was checked.

  • Product quality review (PQR)A Cipla corporate PQR procedure was in place describing the steps to verify consistency of existing processes, appropriateness of established specifications for starting materials, in process and finished products.

  • Product quality review (PQR)The SOP “Product Quality review” was reviewed.

  • Product quality review (PQR)A PQR procedure was in describing the steps to verify consistency of existing processes, appropriateness of established specifications for starting materials, in process and finished products as well as monitoring trends.

  • Product quality review (PQR)The Praziquantel 2015 PQR was reviewed during the last inspection.The PQR 2016 for Praziquantel was not yet available at the time of inspection.


More Definitions of Product Quality Review

Product Quality Review means regular, periodic, or rolling quality reviews of all medicinal products, including export-only products, conducted to verify the consistency of the existing process,
Product Quality Review means the annual quality review of the Product with the objective of verifying the consistency of the existing methods, the appropriateness of current Specifications and specifications of Starting Materials to highlight any trends and to identify Product and method improvements.
Product Quality Review shall have the meaning set forth in Section 6.2.
Product Quality Review means the annual product review report as described in Eudralex Vol. 4 GMP chapter I Quality Management;

Related to Product Quality Review

  • 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.

  • High Quality Waters means all state waters, except:

  • 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.

  • 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.

  • 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;

  • 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.

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

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

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

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

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

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

  • 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;

  • 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.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • 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.

  • Quality Assurance Plan or “QAP” shall have the meaning set forth in Clause 11.2;

  • 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.

  • Runtime Product means the version specific files and application program interfaces (APIs) specified in the RUNTIME.TXT file provided with SAP Crystal Reports 2008, SAP Crystal Reports for Eclipse 2.0, and SAP Crystal Reports for Visual Studio 2010.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • 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.

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

  • Quality Plan means the quality plan to be produced by the Contractor in accordance with Schedule S2-10 (Quality Plan);

  • Product Backlog means a list of those Stories that do not form part of the current Sprint Plan at that time and which are to form the subject of a future Sprint, either in the current Release at that time or a subsequent Release;

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • Product Category means the applicable category which best describes the product as listed in this Section 94508.