QA Audits. The Supplier’s quality program shall be subject to auditing by the Purchaser. Such audits will vary depending upon the Supplier’s performance, past records, the results of surveillance, and other factors. The Supplier shall respond to all audit findings in writing within 30 days after receipt of the audit report. The audit report will provide instructions for responding to audit findings. Responses to reports of nonconforming items shall be documented and corrective action accomplished within a timetable agreed upon by the Purchaser and the Supplier. Subcontractors shall also be subject to audit by the Purchaser.
QA Audits. Upon Purchaser’s reasonable written advance request to Supplier, Purchaser shall have the right to have representatives visit the Supplier Facility during normal business hours to review Supplier’s manufacturing operations and assess its compliance with quality assurance standards and to discuss any related issues with Supplier’s manufacturing and management personnel.
QA Audits. Not more frequently than […***…] during the Term, upon Sequenom’s reasonable advance written notice to Supplier, Sequenom shall have the right to have its representatives visit the Supplier’s manufacturing facility to review Supplier’s manufacturing operations related to Supplier Products and assess its compliance with applicable laws, rules and regulations and quality assurance standards and to discuss any related issues with Supplier’s manufacturing and management personnel. To the extent such Sequenom representatives are third parties and not employees of Sequenom or a Sequenom Affiliate, Sequenom shall obtain Supplier’s advance approval to Sequenom’s use of such third party representatives for such QA audit, such approval not to be unreasonably withheld, and such approved third party shall be required to sign an appropriate confidentiality agreement with Supplier.
QA Audits. Upon written notice of no less than [***] ([***]) Business Days for routine audits to Manufacturer, Company and Collaboration Partner shall have the right to have representatives visit the Facilities during normal business hours to review Manufacturer’s manufacturing operations, assess its compliance with cGMPs and quality assurance standards, and discuss any related issues with Manufacturer’s manufacturing and management personnel. Manufacturer shall maintain the Facilities in accordance with cGMPs. Manufacturer’s failure to correct any cGMP deficiency regarding any aspect of Manufacturer’s manufacture within a reasonable time period after notice of such deficiency shall be a material breach of this Agreement. Upon reasonable notice, the Manufacturer will allow employees of the Company and its Collaboration Partner access to the Facility, documentation, and personnel to audit and for observation of the production process and quality control testing of the Exenatide Injection, disposal of waste and adherence to cGMP requirements and this Agreement. During such inspections, employees of the Company and its Collaboration Partner (number of persons should be restricted to not more than [***] ([***])) shall have the right to audit any aspect of the Manufacturers manufacture of Exenatide Injection, and such audit may include, without limitation, verification of Manufacturers maintenance of drug establishment registrations with the FDA and other applicable Regulatory Authorities, and review of conditions and documentation of any aspect of manufacture of Exenatide Injection.
QA Audits. Upon Customer’s written notice to Supplier (at least 30 days in advance, except in the event that Customer requests an audit in response to an adverse event, complaint or other regulatory action in which case such notice period shall be at least one business day), Customer shall have the right to have its relevant quality assurance representatives visit the Supplier’s manufacturing facility to review Supplier’s manufacturing operations related to Products and assess its compliance with Quality Standards and to discuss any related issues with Supplier’s manufacturing and management personnel subject to the confidentiality obligations as provided in Article 11 with respect to information obtained in the course of such audit; provided that Supplier may limit access by quality assurance representatives of Customer from Supplier’s design history files for the Products (the “Design Files”). Quality assurance representatives of Customer shall not take any records of such audit except for recording of status of compliance with, or deviation from, Quality Standards, and submit to Supplier any and all records taken in the course of such audit. Each such audit shall be conducted during normal business hours. In the event that the audit by Customer reveals any noncompliance issues, Supplier will use diligent and good faith efforts to promptly correct them, which efforts shall include promptly developing a correction plan (including timelines for corrections), working with Customer in good faith to agree upon the correction plan, and complying with said plan; provided that such correction efforts shall not waive any rights or remedies of Customer with respect to such noncompliance.
QA Audits. Upon written notice of no less than [***] Business Days for routine audits to Manufacturer, Company shall have the right to have representatives visit the Facilities during normal business hours to review Manufacturer’s manufacturing operations, assess its compliance with cGMPs and quality assurance standards, and discuss any related issues with Manufacturer’s manufacturing and management personnel. Manufacturer shall maintain the Facilities in accordance with cGMPs. Manufacturer’s failure to correct any cGMP deficiency regarding any aspect of Manufacturer’s manufacture within a reasonable time period after notice of such deficiency shall be a material breach of this Agreement. Upon reasonable notice, the Manufacturer will allow employees of the Company access to the Facility, documentation, and personnel to audit and for observation of the production process and quality control testing of the Product, disposal of waste and adherence to cGMP requirements and this Agreement. During such inspections, employees of the Company (number of persons should be restricted to not more than [***]) shall have the right to audit any aspect of the Manufacturers manufacture of Product, and such audit may include, without limitation, verification of Manufacturers maintenance of drug establishment registrations with the FDA and other applicable Regulatory Authorities, and review of conditions and documentation of any aspect of manufacture of Product.
QA Audits. The Parties agree that XXXXXXX shall have the right to conduct an audit of DUSA's facilities, documentation and systems relating to: (1) DUSA's Product Complaint investigational systems; and/or (2) DUSA's Adverse Event reporting responsibilities as described in the Safety Data Exchange Agreement between XXXXXXX and XXXX. All audits shall be conducted in accordance with the rights and limitations provided in Section 17 of the Agreement. XXXXXXX will comply with any audit request of DUSA to make available all documents, electronic or paper, and completely answer questions relating to the activities as defined in this PCMA on reasonable advance notice to XXXXXXX, and in accordance with Section 17 of the Agreement.
QA Audits. XXXXX reserves the right to participate in QA audits of the Contractor’s subcontractors to the extent related to performance of this contract. Upon completion of the QA audit the Contractor shall provide a report capturing the findings, results, and next steps in proceeding with any potential subcontractors. If action is requested for a subcontractor, detailed corrective and preventative plans for addressing areas of non-conformance to ICH and FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to the COR for review and acceptance. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution. • Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors by the Contractor as part of bi-weekly communications; • Contractor shall notify the COR and CO within 10 business days of report completion. The Contractor shall complete the report within 60 days of the audit/site visit, or as negotiated with the COR in writing dependent upon the audit findings; • COR and CO will review the issues report and provide a response to the Contractor within 10 business days; • Once corrective action is completed, the Contractor will provide a final report to the CO and COR within a time frame negotiated with the COR and CO after review of the issues report. • If additional details are needed for clarification of role, responsibility and processes between the Contractor and USG, it will be defined in the Quality Agreement outlined in Article B.5, Section h, below.
QA Audits. BARDA reserves the right to participate in QA audits. Upon completion of the QA audit the Contractor shall provide a report capturing the findings, results, and next steps in proceeding with any potential subcontractors. If action is requested for a subcontractor, detailed corrective and preventative plans for addressing areas of non-conformance to ICH and FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA for review and acceptance. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution. · Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications. · Contractor shall notify the COR and CO within 5 business days of report completion. The Contractor shall complete the report within 60 days of the audit/site visit, or as negotiated with the COR in writing dependent upon the audit findings.
QA Audits. Each party shall secure the right for the other party to inspect any facility where the Product is manufactured, packaged or stored, at all reasonable times during regular business hours and upon not less than five (5) working days' prior written notice. Such inspections shall be for regulatory and quality assurance purposes only.
