Product Quality Review definition

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 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 to verify the consistency of the existing process,

Examples of Product Quality Review in a sentence

  • Product Quality Review (PQR)The SOP “Annual product quality review” was discussed.

  • The Product Quality Review recommendation increased significant data gathering at small plants and effluenttoxicity twice per year.

  • Product Quality Review — The PQR is an assessment to verify the operational consistency of a process based on results trending and non-conformances.

  • Product Quality Review (PQR): The PQR is an assessment to verify the operational consistency of a process based on results trending and non-conformances.

  • Alimera shall [***] review and comment on EyePoint’s draft of the Annual Product Quality Review and shall collaborate with EyePoint to revise the draft Annual Product Quality Review.

  • Document History Revision to include concept of Product Quality Review Commission Européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel – Belgium.

  • The Product Quality Review will consolidate deviations, out of spec, market complaints, corrective & preventive actions, process changes, etc.

  • Periodic review of validated systemsThe status of validated systems was considered annually during Product Quality Review.

  • For additional information, see the primary reviews, including the Drug Substance Quality Review and Drug Product Quality Review by OBP/DBRRII and the Drug Substance Microbiology Review and the Drug Product Microbiology Review by OPMA/DBM.

  • Product Quality Review (PQR)SOP for Product Quality Review was reviewed.


More Definitions of Product Quality Review

Product Quality Review means the annual product review report as described in Eudralex Vol. 4 GMP chapter I Quality Management;
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 means the written review of manufacturing and quality assurance activities for Finished Product in a defined time period.
Product Quality Review shall have the meaning set forth in Section 6.2.

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.

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

  • 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.

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

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

  • 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.

  • Water quality volume means the volume equal to the first one-half inch of runoff multiplied by the impervious surface of the land development project.

  • Product Group or “the Group” means a group of lotteries that has joined together to offer a product pursuant to the terms of the Multi-State Lottery Agreement and the Product Group’s own rules.