Annual Product Review definition

Annual Product Review means an annual evaluation of the quality standards of the Substance and Finished Product in order for the Parties to jointly determine if changes in Specifications, manufacturing or testing procedures are necessary.
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Annual Product Review means a report prepared by CBSB that, on an annual basis, summarizes all aspects of the previous year’s manufacturing history related to the Drug Substance, including but not limited to the production history, changes to the methods of manufacture or testing, process trending data, and all data and documents requested by and required to meet Tercica’s Regulatory Authority commitments for the Annual Report.
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Annual Product Review has the meaning set forth in Section 9.6.
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Examples of Annual Product Review in a sentence

  • A presentation summarizing the RR testing and refinement was given by Steve Weygandt at the NCEP Annual Product Review (see PPT slides for RUC/RR presentation under http://www.emc.ncep.noaa.gov/annualreviews/2008Review/index.html 09.5.4.E2 1 September 2009 (GSD, NCEP)Complete documentation (in Technical Procedures Bulletin-like document) of Rapid Refresh system.

  • Annual Product Review (APR)A retrospective review of the history of a drug, required by the FDA for products manufactured in or importedinto the USA, undertaken on an annual basis.APISee Active Pharmaceutical Ingredient APRSee Annual Product Review AAuditInspection or survey of a site (e.g. a company, a production site) for the purpose of verifying compliance with the requirements it is supposed to fulfil (here: compliance with the GMP regulations and their specifications).

  • The FDA 21CFR 211 requires an Annual Product Review (APR) to evaluate annually the quality standards of each drug product.

  • The USTR also conducts product reviews, most commonly through the Annual Product Review (APR), which despite the name is not always released every year.30 The APR revises the list of products that are eligible for duty-free treatment.

  • Results of the 2019 GSP Annual Product Review, U.S. TRADE REPRESENTATIVE, https://ustr.gov/sites/default/files/files/gsp/Results_of_the_2019_GSP_Annual_Product_Review.pdf (last visited Dec.


More Definitions of Annual Product Review

Annual Product Review means an analysis conducted by DPT personnel on a yearly basis which examines a multitude of subject matter areas, including, but not limited to, changes in cost of raw materials, API, packaging and shipping components, unit volume, production issues, and other similar such issues.
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Annual Product Review. A regular quality review of every licensed medicinal product as required per regulatory requirements. The purpose of this annual review is to verify the consistency of the existing process, the appropriateness of the current specifications, manufacturing, and control procedures, to highlight trends and identify product and process improvements, and to act where needed.
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Annual Product Review will have the meaning provided in Section 8.13 of this Agreement.
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Annual Product Review shall have the meaning set forth in Section II(1) of Schedule D.
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Annual Product Review shall have the meaning provided in Section 5.14 of this Agreement.
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Annual Product Review means an analysis conducted by RENAISSANCE personnel on a yearly basis, consistent with 21 C.F.R. § 211.180 and any comparable regulation in the Primary Territory, which examines a multitude of subject matter areas, including production review and changes in processes, raw materials, API, Packaging and shipping components, unit volume, production, and other similar such issues.
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Annual Product Review. The review of manufacturing and control activities to be undertaken on an annual basis as defined by 21 CFR Part 211.
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