Significant Deviation definition

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 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.

Examples of Significant Deviation in a sentence

• Significant Deviation: A protocol deviation that affects the scientific design/integrity of the study; affects the rights, safety, or welfare of study subjects; changes the risk/benefit ratio; or violates an ethical principle.

• Any Expense which shall exceed its prescribed Budget shall solely be the responsibility of the party incurring it unless such expense is required to implement an approved Significant Deviation from the Annual Business Plan or is necessary to support sales orders above budgeted sales pursuant to sales programs contemplated by the Annual Business Plan.

• Where a conclusion of overall significant deviation is reached on an ex post basis on outturn data, this triggers a Significant Deviation Procedure (SDP), which starts with a COM’s warning to the country in question and can lead to an interest-bearing deposit being required, for euro area countries, in the event that the significant deviation is not addressed appropriately.

• A deviation is ‘significant’ if it is in excess of 0.5 % of GDP in a single year, or cumulatively over two consecutive years: this leads to the opening of a Significant Deviation Procedure (SDP).

• To get a feeling for this, it can be said that gauge couplings drive the masses up, whereas Yukawa interactions lower them.

More Definitions of Significant Deviation

Significant Deviation means an omission, alteration or relocation of an erosion or

Significant Deviation has the meaning set forth in Attachment B of this QUALITY AGREEMENT.

Significant Deviation has the meaning set forth in the Contract Manufacturing Agreement.

Significant Deviation means: (i) any specification that either falls outside the Approved Package or that cannot be defined because the Approved Package lacks the required information, and whose extrapolation cannot be made, in a straightforward fashion, by means of Foreground or Background. Significant Deviation consists, among others, in : • [***] • Changes in Propanol specification • Changes in safety philosophy Significant Deviation does not include minor changes that are linked to (a) overall performance optimization as a result of the integration of the PFT in existing facilities, (b) lay-out or (c) plot plan considerations. (ii) any and all deviation from HSE matters covered by the Approved Package; (iii) any and all freedom to operate matters not identified pursuant to Paragraphs 9.1 and 9.2.

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 means a deviation with a potential impact on Product quality or regulatory documents.

Significant Deviation means a change that could potentially cause the Product to fail to meet product registration and GMP requirements. This would also be categorized as a critical or major deviation.