Deviation Report definition

Deviation Report means a report used to obtain approvals to temporarily modify or to document exceptions to usual operating, Manufacturing, packaging, testing instructions, test results or procedures. A Deviation Report does not permanently change existing instructions or standard operation procedures, it is intended to be a specific, “one-time-use” document;
Deviation Report shall have the meaning provided in Section ---------------- 9.3(b) of this Agreement.
Deviation Report means the report compiled by Company to document any Deviations.

Examples of Deviation Report in a sentence

  • The Deviation Report shall be attached to, and shall accompany, copies of all relevant batch records.

  • Attached as an exhibit to such Deviation Report shall be copies of all relevant batch records.

  • To Sellers’ Knowledge, except as set forth on Part 3.22(g) of the Seller Parties Disclosure Schedule, no circumstances have arisen that would require Acquired Company to submit a Biological Product Deviation Report to the FDA.

  • To Sellers’ Knowledge, except as set forth on Part 3.22(g) of the Seller Parties Disclosure Schedule, no circumstances have arisen that would require Company to submit a Biological Product Deviation Report to the FDA.

  • If Bayer rejects a shipment of PPF based on a Deviation Report, it shall promptly notify Supplier, such PPF shall be considered a Nonconforming Product and the provisions of Section 7.1 shall apply.

  • Any batch or shipment of Final Product that is the subject of a nonconformity or a Deviation Report shall not be shipped to GS, unless otherwise directed by GS, or, if such Final Product was shipped and is held in stock by GS, then it shall be given a “Hold” or “Unpassed” status and shall not be released into the passed inventory of GS until GS has completed any investigations related to such Products and approved the disposition of the Final Product.

  • During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor shall submit a Deviation Report.

  • If Purchaser rejects a shipment of the Products based on a Deviation Report, it shall promptly notify Bayer, such Products shall be considered Nonconforming Products and the provisions of Section 6.1 shall apply.

  • To Seller’s Knowledge, except as set forth on Schedule 2.18(g), no circumstances have arisen that would require Seller to submit a Biological Product Deviation Report to the FDA.

  • If ▇▇▇▇▇ rejects shipment of the Contractual Products based on a Deviation Report, it shall promptly notify Talecris GmbH, such Contractual Products shall be considered Nonconforming Products and the provisions of Section 12.1 shall apply.


More Definitions of Deviation Report

Deviation Report has the meaning set forth in Section 5.4.1.
Deviation Report means a written report that describes and justifies any deviation from the written production and process control procedures for the Product in compliance with the applicable provisions of cGMP regulations for API.

Related to Deviation Report

  • Condition Report means a condition report with respect to a Group III Vehicle, signed and dated by a Lessee or a Franchisee and any Manufacturer or its agent in accordance with the applicable Vehicle Disposition Program.

  • Exception Report The report of the Trustee referred to in Section 2.02.

  • Evaluation Report means that document which becomes a part of the employee’s personnel file.

  • Verification Report As defined in Section 4.19.

  • Inspection Report means the report delivered by the Master Servicer or the Special Servicer, as the case may be, substantially in the form of Exhibit L hereto.