Batch Record Review Sample Clauses

Batch Record Review. A copy of the first batch master, allbatch records (bulk manufacture, bulk analytics, bulk packaging) and the corresponding batch record review sheets prepared by Unigene QA of PRODUCT(S) are reviewed by Novartis TRD QA Services at the Unigene facilities for release by Novartis. If the batch master document is changed, it needs to be approved again by Novartis TRD QA Services prior to manufacture. Paragraph 11 (Release of Products for Clinical Studies) Unigene issues a certificate of analysis of the PRODUCT(S) using the specifications given in the batch record. Novartis upon receipt of the PRODUCT(S) will perform an identity and potency testing. NOVARTIS initials: UNIGENE initals: CONFIDENTIAL – contains proprietary information and may not be divulged without prior approval of Contract parties. The decision to release the PRODUCT(S) for technical and/or investigational human use shall be the responsibility of Novartis.
Sample 1
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Batch Record Review. A copy of the first batch master, allbatch records (bulk manufacture, bulk analytics, bulk packaging) and the corresponding batch record review sheets prepared by Unigene QA of PRODUCT(S) are reviewed by Novartis TRD QA Services at the Unigene facilities for release by Novartis. If the batch master document is changed, it needs to be approved again by Novartis TRD QA Services prior to manufacture. Paragraph 11 (Release of Products for Clinical Studies) Unigene issues a certificate of analysis of the PRODUCT(S) using the specifications given in the batch record. Novartis upon receipt of the PRODUCT(S) will perform an identity and potency testing. NOVARTIS initials: UNIGENE initials: CONFIDENTIAL – contains proprietary information and may not be divulged without prior approval of Contract parties. Amendment No. 1 to QA Agreement between Novartis and Unigene The decision to release the PRODUCT(S) for technical and/or investigational human use shall be the responsibility of Novartis. Paragraph 16 (Change Control) Unigene has a change control procedure in place. Novartis has to be informed by Unigene prior to any planned change for batches supplied to Novartis. Change requests should be supported by appropriate technical documentation (test data, drawings, explanations etc.) to support the change and to confirm that technical performance has not been altered. Prior to the implementation of a quality relevant change related to the manufacture and analysis of PRODUCT(S), Novartis has to be informed and must agree in writing. Signatures: Unigene Laboratories, Inc. NAME NAME Date Date Novartis Pharmaceutical Corporation NAME NAME Date Date NOVARTIS initials: UNIGENE initials: CONFIDENTIAL – contains proprietary information and may not be divulged without prior approval of Contract parties. EXHIBIT B CONTRACT MANUFACTURING AGREEMENT dated as of by and between Unigene Laboratories, Inc. and Sandoz GmbH TABLE OF CONTENTS 1. DEFINITIONS 1 2. XXXXXXXXXX XXXXX 0 3. PILOT PHASE 9
Sample 1
Batch Record Review. CYTOVANCE QA shall complete batch record audits for each lot of product manufactured according to CYTOVANCE standard operating procedures within 30 business days of completion of the final batch. This review shall confirm records are satisfactory for, including but not limited to, applicable analytical test results for products, in-process material, and component testing, production records, and all batch related deviation and investigation documentation. (CYTOVANCE will notify CLIENT if it is determined that testing or investigation activities will exceed the 30 business day time frame.) CYTOVANCE shall provide written certification that the batch record has been satisfactorily reviewed prior to batch record transfer. CYTOVANCE shall also provide written certification that the batch was manufactured under cGMP conditions.
Sample 1

Related to Batch Record Review

  • Program Review The Contracting Officer or other authorized government representative may hold semi- annual program review meetings. Such meetings will be held via telecom or video teleconferencing. However, the Government reserves the right to request a meeting in person. The meetings will include all BPA holders, representatives from prospective customer agencies, a combination of current and prospective customer agencies, or individual BPA holders. Some Federal Government Agencies and any approved State, Local and Tribal agencies may establish a central program management function. Such users may require their primary suppliers to participate in agency program review meetings on a periodic basis, at no additional cost to the Government.

  • SITE VISITS AND RECORD REVIEW The Applicant shall allow authorized employees of the District, the Comptroller, the Appraisal District, and the State Auditor’s Office to have reasonable access to the Applicant’s Qualified Property and business records from the Application Review Start Date through the Final Termination Date, in order to inspect the project to determine compliance with the terms hereof or as necessary to properly appraise the Taxable Value of the Applicant’s Qualified Property.

  • Log Reviews All systems processing and/or storing PHI COUNTY discloses to 11 CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY 12 must have a routine procedure in place to review system logs for unauthorized access.

  • Validation Review In the event OIG has reason to believe that: (a) Good Shepherd’s Claims Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Claims Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the Claims Review complied with the requirements of the CIA and/or the findings or Claims Review results are inaccurate (Validation Review). Good Shepherd shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports submitted as part of Good Shepherd’s final Annual Report shall be initiated no later than one year after Good Shepherd’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Good Shepherd of its intent to do so and provide a written explanation of why OIG believes such a review is necessary. To resolve any concerns raised by OIG, Good Shepherd may request a meeting with OIG to: (a) discuss the results of any Claims Review submissions or findings; (b) present any additional information to clarify the results of the Claims Review or to correct the inaccuracy of the Claims Review; and/or (c) propose alternatives to the proposed Validation Review. Good Shepherd agrees to provide any additional information as may be requested by OIG under this Section III.D.3 in an expedited manner. OIG will attempt in good faith to resolve any Claims Review issues with Good Shepherd prior to conducting a Validation Review. However, the final determination as to whether or not to proceed with a Validation Review shall be made at the sole discretion of OIG.

  • Conformity Assessment Procedures 1. The Parties recognise that a broad range of mechanisms exist to facilitate the acceptance of conformity assessment results, including:

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Certificate of Analysis Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).

  • AUDIT REVIEW PROCEDURES A. Any dispute concerning a question of fact arising under an interim or post audit of this AGREEMENT that is not disposed of by AGREEMENT, shall be reviewed by LOCAL AGENCY’S Chief Financial Officer.

  • Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.

  • Project Review A. Programmatic Allowances

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