Master Batch Records Sample Clauses

The Master Batch Records clause establishes the requirements for creating and maintaining comprehensive documentation for each batch of a product manufactured. This clause typically mandates that detailed records be prepared before production begins, outlining the materials, equipment, procedures, and quality control measures to be used. By ensuring that every batch is produced and documented according to a standardized protocol, this clause helps maintain product consistency, supports regulatory compliance, and facilitates traceability in the event of quality issues or recalls.
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Master Batch Records. (a) POLYPEPTIDE will prepare Master Batch Records to include directions in sufficient detail to manufacture the bulk drug substance under cGMP guidelines. INTRABIOTICS reserves the right to review and approve the Master Batch Records prior to their use in the production of intermediates or bulk drug substance. (b) POLYPEPTIDE will notify INTRABIOTICS of proposed changes to the Master Batch Record in advance of the proposed implementation. A verbal telephone call outlining significant changes to responsible person is acceptable, but shall be confirmed in writing; telefax transmission is acceptable. INTRABIOTICS acceptance or rejection of the proposed changes will be provided in writing before implementation; telefax transmission is acceptable. (c) INTRABIOTICS shall be notified about proposed deviations in a timely manner. INTRABIOTICS will respond to proposed deviations in writing; telefax transmission is acceptable. (d) Master Batch Record changes shall be finalised in typed written format and approved in writing by representatives of both POLYPEPTIDE and INTRABIOTICS.
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Master Batch Records. 3.1.1 PPL-SD is responsible for creating and amending MASTER BATCH RECORDS. Dipexium will have a time period as mutually agreed to provide written comments to PPL-SD if written comment is required. If written comment is not received within such time period, PPL-SD may proceed without written comment. Documentation changes that are purely administrative and not process related do not require Dipexium’s approval. X X 3.2.2 For those changes required to comply with APPLICABLE LAWS and US regulatory requirements, PPL-SD will notify Dipexium of such requirements after PPL-SD becomes aware of the need for such change. Dipexium’s comment shall not be required for such changes. X X
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Master Batch Records. The Master Batch Records shall be treated as Confidential Information of Company and shall not be used or disclosed by SAFC other than for the purposes of permitting SAFC to exercise its rights or fulfil its obligations under this Agreement (including but not limited to, the provision of the Master Batch Record to Company for quality review) and, where necessary, for disclosure to the relevant Regulatory Agencies in order to comply with regulatory requirements relating to the Manufacturing of Product by SAFC.
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Master Batch Records. The API Manufacturing Procedures contained in the Master Batch Records shall, except to the extent based on or reflecting methods, techniques, processes and standard operating procedures covered by Cempra Licensed Patents or Cempra’s know-how related thereto provided by Cempra to FFFC, be based upon applicable FFFC technology, and any applicable API Improvements. The Master Batch Records shall contain such items and requirements as typical and customary in the industry for manufacturing processes applicable to similar bulk pharmaceutical manufacturing, and shall be set forth in a written document. The API will be Manufactured to the then-current API Specifications at the time of manufacturing. If appropriate during the Term (such as, to include new API Improvements that are useful to Manufacturing the API), the Parties will agree on appropriate amendments or modifications to the API Specifications and/or the Master Batch Record. The details of the procedure for amending the API Specifications and/or the Master Batch Records shall be as specified in the Quality Agreement. FFFC will, at its cost, provide all documents required under the Quality Agreement or this Agreement to be provided to Cempra, in English. FFFC shall not have any obligations to disclose any information maintained in the DMF as confidential to Cempra or any Third Parties, provided that, if (i) either Party or any Affiliate is required by Applicable Law or to satisfy any obligation thereunder, (ii) either Party or any Affiliate thereof is requested by a Regulatory Authority, or (iii) it is reasonably necessary to satisfy any requests of any Regulatory Authority, in the case of (i), (ii) or (iii), to disclose any information maintained in the DMF as confidential, (X) Cempra and FFFC shall promptly use reasonable efforts to, as quickly as possible, determine the reasonable plan for satisfying such requests by mutual good-faith and reasonable consultation based on the careful study of confidentiality of such information maintained in the DMF and (Y) FFFC shall in any event be required to disclose such information if and as reasonably necessary to satisfy, or enable Cempra, any Affiliate thereof, or any licensee or sublicensee of either of the foregoing with respect to Drug Product in the Territory to satisfy, any such requests or requirements. For clarity, in this case, such information maintained in the DMF which is disclosed hereunder shall be used and disclosed only to the extent necessary ...
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Master Batch Records. The license holder has to approve the master batch records for commercial production of its product. All changes of the batch records which impact regulatory filings identified by BI QA require written approval of the license holder prior to revision of the batch records and implementation of the changes.
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Master Batch Records. Emergent shall prepare and maintain the Master Batch Records for the Manufacturing of Products at the Manufacturing Facility. Subject to Section 4 of the Quality Agreement, Emergent may make changes to a Master Batch Record that (i) Emergent believes in its good faith judgment are required to maintain the Manufacturing Facility’s compliance with GMP or (ii) are required by the applicable Regulatory Authority (if Emergent is so informed of such requirement by written notice from Aptevo or a Regulatory Authority). Emergent will use commercially reasonable efforts to make changes to the Master Batch Record with ample time and consideration for required filings, as applicable, to ensure Aptevo’s relevant biologics license applications remain in compliance.
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Master Batch Records. Within sixty (60) days after the approval by both Parties of the validation summary report, as evidenced by signature thereof, the Parties shall develop and agree upon the Master Batch Records.
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Master Batch Records. ▇▇▇▇▇▇ may transcribe the manufacturing information into its own format and will obtain written approval from Halozyme for each document version before manufacturing. However, agreed upon changes to documentation will be handled as outlined by Change Management (see Section 10).
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Master Batch Records. The Parties shall develop and agree upon the Master Batch Records no later than one (1) month before the start of the manufacturing campaign for the commercial supply of the API Compound.
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Related to Master Batch Records

  • Project Records Borrower shall: Make and keep books, records, and accounts, in such reasonable detail, so as to fully, accurately, and fairly reflect the activities of Borrower. Record the Project’s assets, liabilities, revenues, expenses, receipts and disbursements in separate accounts from any other assets, liabilities, revenues, expenses, receipts and disbursements of Borrower so as to permit the production of a Statement of Financial Position, a Statement of Profit and Loss (Statement of Activities), and a Statement of Cash Flows for Borrower in which the activities of Borrower are separately identifiable from the activities of the Operator, unless Borrower is also Operator. Devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances that: Transactions are executed, and access to assets is permitted, only in accordance with ▇▇▇▇▇▇▇▇’s authorization; Transactions are accurately and timely recorded to permit the preparation of quarterly and annual financial reports in conformity with applicable Program Obligations; Transactions are timely recorded in sufficient detail so as to permit an efficient audit of the Borrower’s books and records in accordance with Generally Accepted Auditing Standards (GAAS), Generally Accepted Government Auditing Standards (GAGAS), and other applicable Program Obligations; and Transactions are timely recorded in sufficient detail so as to maintain accountability of the Borrower’s assets. The recorded accountability for assets shall be compared with the existing assets at reasonable intervals, but not less than annually, and appropriate action shall be taken with respect to any differences. Make the books, records and accounts of Borrower available for inspection by HUD or its authorized representatives, after reasonable prior notice, during normal business hours, at the Project or other mutually agreeable location or, at HUD’s request, shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes a request for such documents. Include as a requirement in any operating or management contract that the books, records, and accounts of any agent of Borrower, as they pertain to the operations of the Project, shall be kept in accordance with the requirements of this Section 19 and be available for examination by HUD or its authorized representatives after reasonable prior notice during customary business hours at the Project or other mutually agreeable location or, at HUD’s request, the Management Agent shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes the request.

  • 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).

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

  • Education Records Educational Records are official records, files and data directly related to a student and maintained by the school or local education agency, including but not limited to, records encompassing all the material kept in the student’s cumulative folder, such as general identifying data, records of attendance and of academic work completed, records of achievement, and results of evaluative tests, health data, disciplinary status, test protocols and individualized education programs. For purposes of this DPA, Education Records are referred to as Student Data. Personally Identifiable Information (PII): The terms “Personally Identifiable Information” or “PII” has the same meaning as that found in U.C.A § 53E-9-301, and includes both direct identifiers (such as a student’s or other family member’s name, address, student number, or biometric number) and indirect identifiers (such as a student’s date of birth, place of birth, or mother’s maiden name). Indirect identifiers that constitute PII also include metadata or other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty. For purposes of this DPA, Personally Identifiable Information shall include the categories of information listed in the definition of Student Data.