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.

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.

Annual Product Review shall have the meaning provided in Section 5.14 of this Agreement.

Examples of Annual Product Review in a sentence

• At the Client’s request, Patheon will provide a copy of the Annual Product Review Report to the Client at no additional cost.

• 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).

• COMPANY shall receive a copy of DPT’s Annual Product Review for each Product as long as DPT is continuing to produce such Product for COMPANY and for as long as COMPANY’s account is current.

• In addition, the grant award obligates Federal funds for Category C projects and constitutes approval of Category C projects that are not identified at the time of award but have met or will meet all applicable Federal requirements.

• Upon request, Patheon will supply on an annual basis a copy of the Annual Product Review Report which includes all Product data in its control, including release test results, complaint test results, and all investigations (in manufacturing, testing, and storage), that Client reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that Client is required to file with the FDA.

More Definitions of Annual Product Review

Annual Product Review has the meaning set forth in Section 9.6.

Annual Product Review. The review of manufacturing and control activities to be undertaken on an annual basis as defined by 21 CFR Part 211.

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.

Annual Product Review shall have the meaning set forth in Section II(1) of Schedule D.

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.

Annual Product Review means the APR prepared by the COMPANY for each Product. Each APR shall include, but shall not necessarily be limited to, the following information: (i) stability data, (ii) the total number of Product batches formulated during the APR period, including related analytical data for all Product batches which passed or failed quality or other testing during the APR period, (iii) an investigation summary in respect of each Product batch failure, and (iv) a summary of any significant Product processing, packaging or analytical changes. A copy of the final APR for each Product must be forwarded by the COMPANY to PFIZER within five (5) Business Days of completion.

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.