Validation Protocol definition

Validation Protocol means the written protocol which will be mutually approved by the parties in writing prior to the manufacture of the first Validation Batch and which will set forth the tests and acceptance criteria to demonstrate that a process used by Supplier in the manufacture of the Drug does what it purports to do and yields quantities of the Drug which consistently meet the Specifications. The Validation Protocol may be amended from time to time during the term of this Agreement upon mutual agreement of the parties hereto, giving due consideration to applicable legal and regulatory requirements pertaining to the Drug.
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Validation Protocol means a written plan stating how validation will be conducted,
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Validation Protocol means a document describing the activities to be performed in a validation exercise;
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Examples of Validation Protocol in a sentence

  • Development of Validation Protocol for analytical and assay methods to defining product manufacturing control, performance, potency and product stability indication.

  • Within two (2) years of Executive Board interim approval of the Emergency Use Method, the entire Single Lab Validation Protocol should be submitted.

  • Technical Methods of Data Collection and Analysis The CMS Performance Measure Validation Protocol identifies key types of data that should be reviewed as part of the validation process.

  • The Laboratory Methods Review Committee will report to the Executive Board on the status of the Single Lab Validation Protocol data submission.

  • A documentation request, which consisted of the ISCAT or Appendix Z of the CMS Performance Measure Validation Protocol.

  • HSAG prepared a documentation request, which included the Information Systems Capabilities Assessment Tool (ISCAT), Appendix V of the CMS Performance Measure Validation Protocol.

  • Measure-specific worksheets based on Attachment I of the CMS Performance Measure Validation Protocol.

  • Validation Protocol Table 3: Resolution of Corrective Action and Clarification RequestsDraft report clarifications and corrective action requestsRef.

  • The Laboratory Committee will report to the Executive Board on the status of the Single Lab Validation Protocol data submission.

  • Bajaj (2015) “Computational Refinement and Validation Protocol for Proteins with Large Variable Regions Appl.


More Definitions of Validation Protocol

Validation Protocol a written plan describing the process to be validated.
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Validation Protocol means the protocols developed by PONIARD and Heraeus setting out predetermined specifications and quality attributes to be met and the procedures to be adopted for any validation activities hereunder;
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Validation Protocol means the protocol which has been or will be mutually agreed upon by the Parties hereto, which describes the tests and acceptance criteria used to demonstrate that a process yields a given Product which consistently meets the Specifications. A *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Validation Protocol may be amended from time to time upon mutual agreement by the parties hereto with respect to a Product, giving due consideration to Legal Requirements.
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Validation Protocol means the validation of lots of API under a validation protocol prepared in accordance with the Quality Agreement.
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Validation Protocol means the protocol for the production of the Validation Campaign of API, set forth in Exhibit 1.20 attached to and included in this Agreement, as may be amended from time to time by written agreement of the Parties.
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Validation Protocol means a document [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. developed by Mikart and approved by Transcept which shall: (i) describe the manufacturing process, (ii) describe objective and measurable criteria for control of the manufacturing process, (iii) define the length and duration of the validation, and (iv) describe the equipment used in the manufacturing process.
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Related to Validation Protocol

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

  • Step therapy protocol means a protocol or program that establishes the specific

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Kyoto Protocol means the protocol to the UNFCCC adopted at the Third Conference of the Parties to the UNFCCC in Kyoto, Japan on 11 December 1997 as may be amended;

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Drug use test means a scientifically substantiated method to test for the presence of illegal or performance-enhancing drugs or the metabolites thereof in a person’s urine.

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Manufacturing Process means any process for—

  • ERCOT Protocols means the document adopted by ERCOT, including any attachments or exhibits referenced in that document, as amended from time to time, that contains the scheduling, operating, planning, reliability, and settlement (including customer registration) policies, rules, guidelines, procedures, standards, and criteria of ERCOT. For the purposes of determining responsibilities and rights at a given time, the ERCOT Protocols, as amended in accordance with the change procedure(s) described in the ERCOT Protocols, in effect at the time of the performance or non-performance of an action, shall govern with respect to that action.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Interoperability means the ability of a CenturyLink OSS Function to process seamlessly (i.e., without any manual intervention) business transactions with CLEC's OSS application, and vice versa, by means of secure exchange of transaction data models that use data fields and usage rules that can be received and processed by the other Party to achieve the intended OSS Function and related response. (See also Electronic Bonding.)

  • 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;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Distribution Protocol means the plan for distributing the Settlement Amount and accrued interest, in whole or in part, as approved by the Courts.

  • Aircraft Protocol means the official English language text of the Protocol to the Convention on International Interests in Mobile Equipment on Matters Specific to Aircraft Equipment, adopted on November 16, 2001, at a diplomatic conference in Cape Town, South Africa, and all amendments, supplements, and revisions thereto (and from and after the effective date of the Cape Town Treaty in the relevant country, means when referring to the Aircraft Protocol with respect to that country, the Aircraft Protocol as in effect in such country, unless otherwise indicated).

  • Acceptance Testing mean the tests, reviews and other activities that are performed by or on behalf of Agency to determine whether the Deliverables meet the Acceptance Criteria or otherwise satisfy the Agency, as determined by the Agency in its sole discretion.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • Project Implementation Manual or “PIM” means the manual setting out the measures required for the implementation of the Project, as the same may be amended from time to time, subject to prior approval of the Association;

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Study means the investigation to be conducted in accordance with the Protocol.