Significant Deviation shall have the meaning set forth in Section 4.3(c) hereof.
Significant Deviation means any deviation: (i) resulting in an immediate or probable wide-ranging impact on GMP products, processes or systems in any facility where activities are conducted pursuant to this Agreement, (ii) which could result in significant Product safety or efficacy risks (e.g., sterility failure or data integrity issues), (iii) which would require notification to a regulatory authority, or (iv) which would otherwise be considered by reasonable quality assurance professionals to be significant.
Significant Deviation means an omission, alteration or relocation of an erosion or
Examples of Significant Deviation in a sentence
Significant Deviation – A departure from an approved instruction, a standard operation, or a predefined critical parameter, or an unanticipated event that could have an adverse impact, respectively, on the final quality, stability, and/or physical characteristics of the Product.
More Definitions of Significant Deviation
Significant Deviation means:
Significant Deviation has the meaning set forth in Attachment B of this QUALITY AGREEMENT.
Significant Deviation means any material non-conformity from established requirements as provided in the applicable product registration, applicable validation and/or qualification documents as well as applicable Batch production records and associated procedures, methods and Specifications.
Significant Deviation has the meaning set forth in the Contract Manufacturing Agreement.
Significant Deviation means a material variance from the Project Proposal, in so far as the contribution of the Subgrantee is concerned, which might affect the objectives of the Project or the adequate use of the Subgrant, regardless of the cause, e.g. changes in outcome and/or output level, changes to the respective indicators or to crucial activities.
Significant Deviation and "material impact" shall mean a material variance from the Bank's strategic plan submitted pursuant to this Agreement, as the term "significant deviation" is further described in PPM 5400-9, Appendix B. (x) Xxx xxxposes of Article VIII, the term "material impact" shall have the meaning described in PPM 5400-9, Appendix B.
Significant Deviation means a deviation with a potential impact on Product quality or regulatory documents.