For Cause Audit definition

For Cause Audit means an audit of manufacturing records of Patheon or its subcontractors and supplies by Client following: (a) an unfavorable observation during regulatory inspections that is material to the quality of Product; or (b) a major or repeated quality excursion that may result in a failed manufacture Batch or Non-Conforming Product;

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For Cause Audit means any of a series of inspections conducted for various compelling reasons (questionable data in a final report, tips from informers, etc.).

For Cause Audit means an audit in the case of an emergency (such as material Product defects or regulatory actions) or material non-compliance with any of the Compliance Requirements.

Examples of For Cause Audit in a sentence

A For Cause Audit may be conducted on at least ten (10) days notice.
The JSC will review events that may give rise to the right to conduct a For Cause Audit if so requested by either Party.
If GSK notifies Amgen that GSK desires to conduct either a For Cause Audit or Routine Audit of a Third Party manufacturer, Amgen will notify GSK if Amgen’s contract with such Third Party manufacturer permits GSK to conduct such audit, in which case Amgen will allow GSK to conduct such audit (with Amgen’s participation, if it chooses).
Such audit(s) will require reasonable prior written notice, no less than 45 days (other than in the case of a For Cause Audit by Tokai and be subject to commercially reasonable security and safety procedures.
Zogenix will reimburse Supplier for its time and expenses associated with any additional audit during such calendar year (audits of no more than [***] in duration with no more than [***] auditors) unless such audit is as a result of a Supplier breach of, or noncompliance with, or reveals that Supplier has breached, or is not in compliance with, this Agreement or any Applicable Law (For Cause Audit).

More Definitions of For Cause Audit

For Cause Audit means an audit performed to investigate a specific quality failure or process deviation and/or to prepare for a regulatory inspection.

For Cause Audit means an audit performed to investigate and resolve issues related to the quality or acceptability of released Bulk Drug Substance.

For Cause Audit means a site visit other than routine audits or business discussion, for the purpose of reviewing documentation, facilities or processes related to a serious quality concern or an adverse event.

For Cause Audit has the meaning set forth in Section 8.4(b).

For Cause Audit has the meaning set forth in Section 3.14.4 (Manufacturing).

For Cause Audit has the meaning set forth in Sections 7.6(b) and 7.6(d).

For Cause Audit shall have the meaning set forth in the Quality Agreement.