Audits by Reliant Pharmaceuticals Sample Clauses
The "Audits by Reliant Pharmaceuticals" clause grants Reliant Pharmaceuticals the right to review and examine the records, processes, or facilities of another party to ensure compliance with contractual obligations. In practice, this may involve scheduled or unscheduled inspections, access to financial documents, or verification of regulatory adherence related to the agreement. The core function of this clause is to provide Reliant Pharmaceuticals with oversight and assurance that the other party is meeting its commitments, thereby reducing the risk of non-compliance or contractual breaches.
Audits by Reliant Pharmaceuticals. 7.1 Reliant Pharmaceuticals shall have the right to perform periodic audits of departments responsible for the manufacture of the drug product. Patheon shall provide Reliant Quality, or representative, access to all facilities and records pertaining to the manufacture of the drug product.
7.2 Reliant Quality, or representative, shall provide an exit meeting to Patheon to provide significant observations. A written report of observations shall be issued to Patheon.
7.3 Patheon shall provide a written response to the audit observations within 20 business days. The response shall include details of the corrective actions to the observations, and the expected completion date of the action. Reliant Quality shall follow-up on the progress of the corrective actions based on the expected completion dates provided.
Audits by Reliant Pharmaceuticals. 7.1 Routine Audits may be performed by Reliant or its agent upon prior notification, and not more than once a year. CGMP compliance audits of Cardinal’s facilities may be conducted during regular business hours, and may cover any system or area, plus associated documentation, used to support receiving, sampling, testing, releasing and holding of raw materials, or manufacturing, sampling, testing, releasing, labeling, holding, and distribution of the drug product.
7.2 Reliant Quality shall provide 180 days notification for a routine audit, and 7 days notification for a ‘for cause’ audit pertaining to a specific product quality and safety issue. A ‘for cause’ audit does not constitute a routine audit.
7.3 An exit meeting shall be held to provide significant audit observations. A written report of observations shall be issued.
7.4 Cardinal shall provide a written response to the audit observations within 30 business days of receipt of written observations from Reliant. The response shall include details of the corrective actions to the observations, and the expected completion date of the action. Reliant Quality shall follow-up on the progress of the corrective actions based on the expected completion dates provided.
7.5 Reliant shall have the right to be present during the manufacture of any product validation lots, or during the manufacture of a lot in which a CAPA issue is being implemented. These visits shall not go against Reliant’s right to an annual audit.
Audits by Reliant Pharmaceuticals. 7.1 Reliant Pharmaceuticals shall have the right to perform audits of departments responsible in the manufacture of the Products at least annually. . Abbott shall provide Reliant Quality, or representative, access to all facilities and records pertaining to the manufacture of the drug product.
Audits by Reliant Pharmaceuticals. 7.1 Reliant Pharmaceuticals shall have the right to perform audits of departments responsible in the manufacture of the Products at least annually. Shasun shall provide Reliant Quality, or representative, access to all facilities and records pertaining to the manufacture of the product.