Annual Product Reviews Clause Samples
The Annual Product Reviews clause requires that products or services provided under the agreement are reviewed on a yearly basis to assess their performance, compliance, and continued suitability. Typically, this involves both parties meeting to discuss product quality, address any issues, and consider updates or improvements based on feedback or changing needs. By mandating regular reviews, this clause ensures ongoing alignment between the parties, helps identify and resolve problems early, and supports continuous improvement throughout the contract term.
Annual Product Reviews. 13.01 Have procedures to conduct and document annual product reviews, if applicable. X
13.02 Allow viewing of the Annual Product Review APR) for the Product during an on-site audit. X
Annual Product Reviews. 4.4.1 Responsible for the performance of chemical and/or PRODUCT annual reviews. • X
4.4.2 Will provide AstraZeneca with distribution data required to perform cGMP annual PRODUCT reviews and NDA annual report as reasonably requested by AstraZeneca X •
Annual Product Reviews. 15. 1Annual Product Review will not be performed until Product is approved for commercial sale.
Annual Product Reviews. DUSA shall conduct an annual product review for annual evaluation of the quality standards for each Collaboration Product to determine the need for changes in the Specifications or manufacturing or control procedures. DUSA shall submit a copy of such annual product review to Schering.
Annual Product Reviews. UPM will, at its cost, perform annual product reviews for the Drug Product in accordance with 21 CFR Part 211.180(e) and the Quality Agreement. Upon completion of reviews UPM will provide a copy of such reviews to ▇▇▇▇▇▇▇▇ as detailed in the Quality Agreement.
Annual Product Reviews. Responsible for the performance of chemical and/or PRODUCT annual reviews. • X
Annual Product Reviews. CONTRACT ACCEPTOR shall prepare an Annual Product Review (“APR”) for the PRODUCT covering the activities executed during the review period. This report will be a review of any changes in the manufacturing, packaging, testing, or validation of the product in the previous year; a summary of lots made, released, and rejected; a stability report. Also, control charting or trend analysis of key product parameters will be performed on an annual basis. Any abnormalities will be explained in the annual review. A copy must be forwarded to UCB within 10 Business Days after completion of the APR. The APR shall be completed within 30 days of its due date, established by a schedule mutually agreed upon by both parties.
Annual Product Reviews. Supplier will, at its cost, perform annual product reviews for the Product in accordance with 21 CFR Part 211.180(e) and the Quality Agreement. Purchaser shall have the right to review the Annual Product Review prior to finalization. Upon completion of reviews Supplier will provide a copy of such reviews to Purchaser as detailed in the Quality Agreement.
