Production and control records Sample Clauses

Production and control records. Drug manufacturers were required to prepare drug product production and control records, and to have those records reviewed and approved by the quality control unit to determine compliance with all established, approved 'Written procedures, before a batch was released or distributed. 21 C.F.R. §§ 211.188 and 192 (2003). Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications were required to be thoroughly investigated whether or not the batch was already distributed, and the investigation was required to extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. 21 C.P.R. § 2 1 1.1 92 (003).
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Production and control records. OCTOPLUS commits himself to keep a record of the production and control of each batch for at least 10 years. After this period they will destroyed after written authorization by ESPERION. ESPERION has the right to view the records during agreed audits.

Related to Production and control records

  • Personnel Records (A) There shall be only one official personnel file for each employee, which shall be maintained by the employing agency. Information in an employee’s official personnel file may be maintained in electronic as well as paper form.

  • Information and Records (a) Lessee shall promptly furnish to Lessor all such information as Lessor may from time to time reasonably request regarding the Aircraft or any part thereof, its use, registration, location and condition. In addition, Lessee shall, on each Maintenance Payments Date and the Termination Date, furnish to Lessor a monthly maintenance status report substantially in the form of Schedule 5.

  • Files and Records A. An employee will have the right to review the contents of files concerning the employee, excluding initial references of the district pertaining to said employee or other items statutorily exempt from disclosure originating after initial employment, and to have a representative of the Association accompany him/her in such a review.

  • Computer Records World Omni and the Depositor will cause their accounting and computer records to be marked to indicate the sale and assignment of the Receivables from World Omni to the Depositor and from the Depositor to the Trust.

  • Access to Books and Records Subject to Section 8.07, from the date hereof until the Closing Date, the Company shall provide the Purchaser and its authorized representatives (the “Purchaser’s Representatives”) and the Debt Financing Source Related Parties with reasonable access during normal business hours and upon reasonable notice to the offices, properties, senior personnel, books and records of the Company and its Subsidiaries in order for the Purchaser to have the opportunity to make such investigation as it shall reasonably desire of the affairs of the Company and its Subsidiaries; provided that, notwithstanding the foregoing, (a) such access does not unreasonably interfere with the normal operations of the Company or its Subsidiaries, (b) such access shall occur in such a manner as the Company reasonably determines to be appropriate to protect the confidentiality of the transactions contemplated by this Agreement, and (c) nothing herein shall require the Company to provide access to, or to disclose any information to, the Purchaser or any of the Purchaser’s Representatives if such access or disclosure would reasonably be expected to (i) cause significant competitive harm to the Company or its Subsidiaries if the transactions contemplated by this Agreement are not consummated, (ii) waive any legal privilege, or (iii) be in violation of applicable Law (including the HSR Act and other antitrust Laws). The Purchaser acknowledges that the Purchaser is and remains bound by that certain Confidentiality Agreement, dated as of April 21, 2015 (as amended from time to time, the “Confidentiality Agreement”), by and between Purchaser and GTCR LLC (“GTCR”). The information provided pursuant to this Section 7.02 will be used solely for the purpose of effecting the transactions contemplated by this Agreement, and will be governed by all the terms and conditions of the Confidentiality Agreement.

  • Books of Account and Records Proper and complete records and books of account shall be kept or shall be caused to be kept by the Board of Directors or such representatives as it may appoint in which shall be entered fully and accurately all transactions and other matters relating to the Company’s business in such detail and completeness as is customary and usual for businesses of the type engaged in by the Company. The books and records shall at all times be maintained at the principal executive office of the Company.

  • Patient Records Upon termination of this Agreement, the New PC shall retain all patient dental records maintained by the New PC or the MSO in the name of the New PC. During the term of this Agreement, and thereafter, the New PC or its designee shall have reasonable access during normal business hours to the New PC's and the MSO's records, including, but not limited to, records of collections, expenses and disbursements as kept by the MSO in performing the MSO's obligations under this Agreement, and the New PC may copy any or all such records.

  • Business Records Keep, and cause each Subsidiary to keep, adequate records and books of account with respect to its business activities in which proper entries are made in accordance with GAAP reflecting all its financial transactions.

  • Financial Records 26.1.1 CONTRACTOR shall prepare and maintain accurate and complete financial records. Financial records shall be retained by CONTRACTOR for a minimum of five (5) years from the date of final payment under this Contract, or until all pending COUNTY, State, and federal audits are completed, whichever is later.

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