Process Performance Qualification definition

Process Performance Qualification or “PPQ” means the process agreed by the Parties for the collection and evaluation of data, from the process design stage through repeated production at final scale, which establishes scientific evidence that a Manufacturing Process is capable of consistently and reproducibly delivering Product meeting Specifications.
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Process Performance Qualification means the collection and evaluation of data, from the Process design stage through repeated production at final scale, which establishes scientific evidence that a manufacturing process is capable of consistently and reproducibly delivering a Product meeting Specifications, as described in the FDA’s Guidance for Industry, Process Validation: General Principles and Practices, January 2011 (Rev. 1), as amended or updated from time to time.
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Process Performance Qualification means the program by which it is established that the process equipment, ancillary systems, and the Process are effective and reproducible.
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Examples of Process Performance Qualification in a sentence

  • FDA generally expects a minimum of three Process Performance Qualification (PPQ) lots per manufacturing facility to support the consistency of vaccine quality.

  • A specific process will consistently produce a product meeting its predetermined specifications and quality attributes (Process Validation {PV} also called Process Performance Qualification {PPQ}).

  • The aim of Process Performance Qualification activities are to performing a robustness manufacturing activity such a constantly produces medicinal product having minimum inconsistency that meeting its quality standard for pureness, identification and effectiveness.

  • If the firm states that it has completed the process validation activities necessary to distribute the finished drug product (i.e., completion of Stage 2, Process Performance Qualification), fully audit and assess these studies and conclusions.

  • During the Term, Customer may request that Brammer provide certain services related to Products that are outside the scope of Brammer's manufacture and supply obligations under this Agreement, such as the conduct of Process Performance Qualification or services related to Process development in connection with a Product and the like (“Development Services”).

  • During the Term, Brammer shall manufacture and supply Product to Customer for clinical trial and commercial supply purposes and for purposes of Process Performance Qualification pursuant to the provisions of this Agreement, the Quality Agreement and any applicable Product Addendum that are mutually agreed to and executed by the Parties in writing.

  • This decision enabled the Company to discuss the best possible path forward for LUMEVOQ® with the EMA, aiming at submitting a new application addressing remaining objections as soon as possible, in Europe and other countries.Given our decision to withdraw the EMA application, there is no immediate need for a Process Performance Qualification ("PPQ") campaign until a new Marketing Authorisation Application ("MAA") is submitted.

  • The usable lifetimes of such materials should be confirmed by an ongoing PPQ (Process Performance Qualification) protocol during commercial manufacture.”The acceptable limits of this variability must be examined, and from these results, optimized operating parameters chosen.

  • As described herein, Eagle conducts pH testing at various stages during the life of a batch including: (1) during compounding, (2) during in-process testing, (3) during release testing, and (4) during stability testing for batches subject to a stability protocol, and Eagle additionally conducted non-routine testing on batches SVA011-013 per its Process Performance Qualification (“PPQ”) Protocol.

  • A validation campaign, or Process Performance Qualification (PPQ) campaign, consists of at least 3 successful GMP (Good Manufacturing Practice, required standards for human use outside of a clinical trial) batches manufactured sequentially to demonstrate and document the robustness, control, consistency and reproducibility of the commercial manufacturing process at the designated commercial facility.


More Definitions of Process Performance Qualification

Process Performance Qualification or “PPQ”). In the event of any conflict between the Scope of Work and this Agreement, the terms of this Agreement shall prevail, except to the extent the Scope of Work expressly deviates from one or more terms of this Agreement and the Parties agree in writing to such deviation.
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Process Performance Qualification or “PPQ” means the collection and evaluation of data, from the Process design stage through repeated production at final scale, which establishes scientific evidence that a manufacturing process is capable of consistently and reproducibly delivering the Product meeting Specifications, as described in the FDA’s Guidance for Industry, Process Validation: General Principles and Practices, January 2011 (Rev. 1), as amended or updated from time to time. Certain confidential information contained in this document, marked by [**], has been omitted because the information (i) is not material and (ii) would likely cause competitive harm to the Company if disclosed.
Sample 1
Process Performance Qualification or “PPQ” means the collection and evaluation of data, from the Process design stage through repeated production at final scale, which establishes scientific evidence that a manufacturing process is capable of consistently and reproducibly delivering the Product meeting Specifications, as described in the FDA’s Guidance for Industry, Process Validation: General Principles and Practices, January 2011 (Rev. 1), as amended or updated from time to time.
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Related to Process Performance Qualification

  • pre-qualification means the first stage of the Bidding Process involving the submission, opening and evaluation of the Qualification Documents submitted by the Prospective Bidders.

  • Minimum Qualifications Qualifications mandated for the position and which must be possessed by an employee before the employee can be considered for employment in a specific classification.

  • Pre-Qualifying Criteria means the criteria set out in clause 27.3 of this Part C.

  • Energy Performance Score means the numeric rating generated by Portfolio Manager that compares the Energy usage of the building to that of similar buildings.

  • the qualifying period means the period of 12 years immediately preceding the date of publication of the advertisements referred to in paragraph (A)(iv) above or of the first of the two advertisements to be published if they are published on different dates; and

  • Index Performance means, in relation to an Index and an Auto-Call Valuation Date or the Valuation Date, as the case may be, a percentage calculated by the Calculation Agent in respect of such date in accordance with the following formula: Index Performance =Final Index Level × 100% Initial Index Level

  • Statement of Qualifications means a written statement submitted to a procurement unit in response to a request for statement of qualifications.

  • Qualified Performance-Based Compensation means any compensation that is intended to qualify as “qualified performance-based compensation” as described in Section 162(m)(4)(C) of the Code.

  • Impermissible Qualification means, relative to the opinion or certification of any independent public accountant as to any financial statement of the Borrower, any qualification or exception to such opinion or certification:

  • Additional Performance Security means the Bank Guarantee to be submitted by Successful Bidder in accordance with Clause 8.7 of this RFP Document

  • Qualifying Performance Criteria means any one or more of the following performance criteria, either individually, alternatively or in any combination, applied to either the Company as a whole or to a business unit, Parent, Subsidiary or business segment, either individually, alternatively or in any combination, and measured either annually or cumulatively over a period of years, on an absolute basis or relative to a pre-established target, to previous years’ results or to a designated comparison group, and on a pre-tax or after-tax basis, in each case as specified by the Committee in the Award: (i) cash flow (including operating cash flow or free cash flow); (ii) earnings (including gross margin, earnings before interest and taxes, earnings before taxes, and net earnings); (iii) earnings per share; (iv) growth in earnings or earnings per share; (v) stock price; (vi) return on equity or average stockholders’ equity; (vii) total stockholder return; (viii) return on capital; (ix) return on assets or net assets; (x) return on investment; (xi) revenue; (xii) income or net income; (xiii) operating income or net operating income; (xiv) operating profit or net operating profit; (xv) operating margin; (xvi) return on operating revenue; (xvii) market share; (xviii) contract awards or backlog; (xix) overhead or other expense reduction; (xx) growth in stockholder value relative to the moving average of the S&P 500 Index or a peer group index; (xxi) credit rating; (xxii) strategic plan development and implementation (including individual performance objectives that relate to achievement of the Company’s or any business unit’s strategic plan); (xxiii) improvement in workforce diversity; (xxiv) expenses; (xxv) economic value added; (xxvi) product quality; (xxvii) number of customers; (xxviii) objective customer indicators; (xxix) customer satisfaction; (xxx) new product invention or innovation; (xxxi) profit after taxes; (xxxii) pre-tax profit; (xxxiii) working capital; (xxxiv) sales; (xxxv) advancement of the Company’s product pipeline; (xxxvi) consummation of strategic transactions; (xxxvii) reduction in cash utilization; and (xxxviii) addition of technologies and products. The Committee may appropriately adjust any evaluation of performance under a Qualifying Performance Criteria to exclude any of the following events that occurs during a performance period: (A) asset write-downs; (B) litigation or claim judgments or settlements; (C) the effect of changes in tax law, accounting principles or other such laws or provisions affecting reported results; (D) accruals for reorganization and restructuring programs; and (E) any gains or losses classified as extraordinary or as discontinued operations in the Company’s financial statements.

  • Data qualifier means a specified character (or string of characters) that immediately precedes a data field that defines the general category or intended use of the data that follows.

  • Qualification Period means the period of time in which the List of Approved Suppliers shall be valid in accordance with the Tender; in which the Company shall have the right, at any time to issue Purchase Order(s) for Goods and/or to approach any or all of the Approved Suppliers and invite them, by way of RFQ to supply Goods, all in accordance with the terms and conditions of the Contract.

  • Qualified Performance-Based Award means an Award intended to qualify for the Section 162(m) Exemption, as provided in Section 11.

  • Performance-based contracting means the structuring of all

  • Qualifying Energy Efficiency Measures (EEMs) means either (i) standard gas or electric EEMs (i.e., measures found on any of the Standard Initiative applications); or (ii) measures eligible under the Custom Initiative approved by Ameren Illinois; or (iii) measures found in the Streetlighting or Retro-commissioning Initiative as identified in official program materials found on the Ameren Illinois Energy Efficiency website. The following technologies are not Qualifying EEMs: (i) technologies that do not demonstrate measurable and verifiable energy savings, including power conditioning; (ii) technologies that displace electrical energy use or natural gas to another fuel (i.e. fuel switching); or (iii) renewable energy projects (solar, wind power, etc.). Eligible gas measures do not include propane or butane measures.

  • Performance Measure means one or more of the following selected by the Committee to measure Company, Affiliate, and/or business unit performance for a Performance Period, whether in absolute or relative terms (including, without limitation, terms relative to a peer group or index): basic, diluted, or adjusted earnings per share; sales or revenue; earnings before interest, taxes, and other adjustments (in total or on a per share basis); basic or adjusted net income; returns on equity, assets, capital, revenue or similar measure; economic value added; working capital; total shareholder return; and product development, product market share, research, licensing, litigation, human resources, information services, mergers, acquisitions, sales of assets of Affiliates or business units. Each such measure shall be, to the extent applicable, determined in accordance with generally accepted accounting principles as consistently applied by the Company (or such other standard applied by the Committee) and, if so determined by the Committee, and in the case of a Performance Compensation Award, to the extent permitted under Code Section 162(m), adjusted to omit the effects of extraordinary items, gain or loss on the disposal of a business segment, unusual or infrequently occurring events and transactions and cumulative effects of changes in accounting principles. Performance Measures may vary from Performance Period to Performance Period and from Participant to Participant, and may be established on a stand-alone basis, in tandem or in the alternative.

  • Extreme performance coating means coatings designed for harsh exposure or extreme environmental conditions.

  • Annual performance report means a written appraisal of the teaching staff member's performance prepared by the teaching staff member’s designated supervisor based on the evaluation rubric for his or her position.

  • energy performance contracting means a contractual arrangement between the beneficiary and the provider of an energy efficiency improvement measure, verified and monitored during the whole term of the contract, where investments (work, supply or service) in that measure are paid for in relation to a contractually agreed level of energy efficiency improvement or other agreed energy performance criterion, such as financial savings;

  • Performance Measurement Period has the meaning set forth in Section 3.1(e)(ii).

  • Control Performance Standard or “CPS” shall mean the reliability standard that sets the limits of a Balancing Authority’s Area Control Error over a specified time period.

  • Total Performance means that the entire Work, except those items arising from the provisions of any warranty, have been performed in accordance with the Contract;

  • Basket Performance means a decimal number calculated by applying the following formula: BP = ∑ W ×iX ⎛⎜⎜i=1 ⎝ Underlyingi,FINAL ⎞⎟⎠Underlyingi,INITIAL ⎟ where: BP = Basket Performance X = 8 Wi = Weighting of the relevant Underlying Underlying i,FINAL Underlying i,INITIAL= Arithmetic mean of the Reference Prices of the relevant Underlying with respect to all Averaging Dates = Initial Price of the relevant Underlying

  • Performance-Based Cash Award means a cash Award under Article XI of this Plan that is payable or otherwise based on the attainment of certain pre-established performance goals during a Performance Period.

  • Request For Qualifications (RFQ means the written solicitation, including all Addenda thereto, issued by the Department seeking SOQs in order to identify and Short-List the Proposers to receive the RFP for the Project.