GMP Documentation definition

GMP Documentation means all GMP documentation owned by Seller or its Affiliates that relates exclusively to the Product

Examples of GMP Documentation in a sentence

  • GMP Documentation Preparation (Product Batch Records) (September 2007) 7.

  • For the avoidance of doubt, prior to delivering or making available any files, documents, instruments, papers, books and records constituting Assigned Contracts, Regulatory Documentation or GMP Documentation, to Buyer, Seller shall be entitled to redact from such files, documents, instruments, papers, books and records any information to the extent that it does not relate to the Operation.

  • Including GMP Documentation and Stability Program for Regulatory Filing between Accelerated Pharma Inc.

  • However, This Is Less Of A Factor With The Advent Of High Resolution Scanners And Colour Copiers.Consistent Use Of Blue And Black Ink On GMP Documentation Provides A More Professional Perception Of Your Organisation.Legible Handwritten Entries:A Document Is Unusable If It Cannot Be Read, So Care Must Be Taken To Ensure That Handwriting Is Legible.

  • American United Life Insurance Company® (AUL) certifies that the Person whose enrollment card is on file with the Participating Unit as being eligible for insurance and for whom the required premium has been paid is insured under the above numbered Group Policy for group insurance benefits as designated in the Schedule of Benefits.

  • SGMA and AB 3030 GMP Documentation The Sacramento Groundwater Authority (SGA) is a joint powers authority originally formed in 1998 to manage the North Basin (SGA, 2014) in response to descending groundwater levels.

  • GMP Documentation RequirementsThese documents are required if the amount claimed exceeds the auto pay threshold or is requested as part of a quarterly post-audit.

  • Generation of GMP Documentation [*] Encap’s activities under this work stage include approval of raw materials (ID testing to USP only) and generating and revising Drug Product specifications and manufacturing master batch documents for review and approval by Client.

  • Dor t7e reasons stated 7erein5 t7e \oint Parties urge t7e Commission to grant t7e Imended \oint Petition as eepeditiously as possible and limit application of t7e Disc7arge Re`uirement to IKS systems coupled wit7 wind tec7nologies only and amend t7e Disc7arge Re`uirement for IKS systems coupled wit7 ot7er SGIP-eligible tec7nologies as followsRZt7e ability to cycle5 or c7ange t7e flow of energy5 multiple times per day.

  • Content The dossier must be compiled in the following order:Inhalt Introduction 1Section 00F Fo Submission Form 4Section 01CL Cover Letter 6Section 02EC EC Correspondence 7Section 03RA Foreign Regulatory Authorities 8Section 04P Trial Protocol 9Section 05S Safety Documentation 10Section 06G GMP Documentation 12Section 07Q Quality Documentation 16Section 08LA Labels 20Section 09PM Pharmacy Manual 23Section 19 Toxicology Reports 24 Section 00F Fo Submission Form‌ 1.

Related to GMP Documentation

  • Design Documentation means all:

  • Related Documentation means, with respect to Software, all materials, documentation (including control documentation utilized in connection with an audit), specifications, technical manuals, user manuals, flow diagrams, file descriptions and other written information that describes the function and use of such Software, but excluding source code.

  • Product Documentation means the specific materials listed under “Documentation” at xxx.xxxxxx.xxx/xxxxx, as updated by Vocera from time to time.

  • User Documentation means that documentation regarding the operation, guidelines and features and functionality of Clover Insights that is made available to you from time to time at the website, by internet link or otherwise. User Documentation may be modified from time to time by First Data or its third party provider(s).

  • Technical Documentation means designs, reports, photographs, drawings, plans, specifications, computer software, surveys, calculations and other data, information and material collected, computed, drawn or produced, including computer print-outs.

  • Program Documentation refers to the user manuals, help windows, readme files for the Services and any Oracle Software. You may access the documentation online at xxxx://xxxxxx.xxx/contracts or such other address specified by Oracle.

  • Software Documentation means software information, being technical information used, or useful in, or relating to the design, development, use or maintenance of any version of a software programme.

  • Limited Documentation Program The guidelines under which the Seller generally originates Mortgage Loans principally on the basis of the Loan-to-Value Ratio of the related Mortgage Loan and the creditworthiness of the Mortgagor.

  • Service documentation means all records and information on one or more documents, including documents that may be created or maintained in electronic software programs, created and maintained contemporaneously with the delivery of services, and kept in a manner as to fully disclose the nature and extent of services delivered that shall include the items delineated in paragraph (E) of this rule to validate payment for medicaid services.

  • Acquisition Documentation collectively, the Acquisition Agreement and all schedules, exhibits and annexes thereto and all side letters and agreements affecting the terms thereof or entered into in connection therewith.

  • Account Documentation means any and all Account information, credit applications, Cardholder Agreements and change in terms notices, Charge Transaction Data, charge slips, credit slips, payments, credit information and documents or forms of any type and in any media relating to the Program, excluding materials used for advertising or solicitations.

  • Supporting Documentation means the documents listed in Schedule A of this Certificate which forms part of this

  • ISM Code Documentation includes, in respect of a Ship:

  • RFP Documents means the following documents to be entered into by the parties to the respective agreements in connection with the supply of power:

  • Flood Documentation means, with respect to each Mortgaged Property located in the United States of America or any territory thereof, (i) a completed “life-of-loan” Federal Emergency Management Agency standard flood hazard determination (to the extent a Mortgaged Property is located in a Special Flood Hazard Area, together with a notice about Special Flood Hazard Area status and flood disaster assistance duly executed by the Borrower and the applicable Loan Party relating thereto) and (ii) a copy of, or a certificate as to coverage under, and a declaration page relating to, the insurance policies required by Section 5.02(c) hereof and the applicable provisions of the Security Documents, each of which shall (A) be endorsed or otherwise amended to include a “standard” or “New York” lender’s loss payable or mortgagee endorsement (as applicable), (B) name the Collateral Agent, on behalf of the Secured Parties, as additional insured and loss payee/mortgagee, (C) identify the address of each property located in a Special Flood Hazard Area, the applicable flood zone designation and the flood insurance coverage and deductible relating thereto and (D) be otherwise in form and substance reasonably satisfactory to the Collateral Agent.

  • Security Documentation means all documents and information made available by Google under Section 7.5.1 (Reviews of Security Documentation).

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • Computer software documentation means owner's manuals, user's manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

  • Participant Documentation means the agreements (together with any applicable schedules, exhibits or appendices thereto required by BSEF) in form and substance acceptable to BSEF, that are required to be executed and delivered to BSEF before a Person may access the SEF operated by BSEF as a Participant. Participant Documentation shall not include DMA Customer Documentation.

  • DIP Documents means the DIP ABL Documents and the DIP Term Loan Documents.

  • Co-Documentation Agent as defined in the preamble hereto.

  • Definitive Documentation means the definitive documents and agreements governing the Restructuring Transactions as set forth in the Restructuring Support Agreement.

  • Design Development Documents means the Drawings, Specifications and other documents prepared by the Trade Contractor that establish and describe the size and character of the Trade Contractor Work as to architectural, civil, structural, mechanical and electrical systems, graphics and signage, and other elements, and which include typical construction details, equipment layouts and specifications that identify major materials and systems.

  • RfS Document means the bidding document issued by MSEDCL including all attachments, clarifications and amendments thereof.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Co-Documentation Agents as defined in the preamble hereto.