Process Performance Qualification definition

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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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 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.

  • Catalent will perform the Product qualification, validation and stability services as described in and in accordance with Process Performance Qualification Protocol No. KP2016-144, as separately agreed by the parties.

  • For clarity, other than the performance of manufacturing activities to supply the Product(s) ordered by Customer hereunder following a successful Process Performance Qualification campaign, all other activities or services of Brammer shall be considered “Development Services” for purposes of this Agreement and this Section 2.1(ii).

  • 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.

  • Following establishment of the Process for a Product pursuant to the Process Performance Qualification, Customer shall be required to purchase at least the minimum number of Batches of Product per quarter, (the “Minimum Purchase Commitment”) as specified in Appendix C.

  • Such Process Performance Qualification may include, but is not limited to, the following tasks which are more fully described in the Scope of Work: [*].

  • If the data following completion of the Process Performance Qualification supports a minimum yield that is lower than [***], the Parties agree to work together in good faith to determine the root cause of the problem.

  • The Scope of Work attached hereto under Exhibit B shall contain pricing for any applicable Development Services, cGMP Manufacturing Runs and Process Performance Qualification activities to be performed by Catalent under this Agreement.

  • The aim of this validation level is to show that product specifications are met in a reliable way through a series of manufacturing consistency lots at commercial scale to demonstrate consistent and reproducible production (i.e., FDA´s Conformance Batches as part of the Process Performance Qualification or PPQ stage).

  • If made part of the Scope of Work as part of Passage Bio’s pre-Commercialization activities of a Passage Bio Product, Catalent shall perform Process Performance Qualification in support of Passage Bio’s BLA submission to the FDA for such Passage Bio Product in accordance with cGMPs, the Specifications, the Quality Agreement, any applicable Laws, and otherwise in accordance with this Agreement.


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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Related to Process Performance Qualification

  • Monthly Qualification Cycle means a period beginning one (1) Business Day prior to the first day of the current Statement Cycle through one (1) Business Day prior to the close of the current Statement Cycle.

  • pre-qualification means a screening process designed to ensure that invitations to bid are confined to capable providers;

  • Minimum Qualifications means the requirements of education, training, experience and other basic qualifications for a job.

  • 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 shall have the meaning set forth in Clause 7.1;

  • 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 a CDC Owner, Operator or a Qualified Colocation Tenant is eligible for Program benefits and means specifically (a) in respect to a CDC Owner or Operator, as defined in subsection IX.A. and (b) in respect to a CDC Qualified Colocation Tenant, as defined in subsection IX.B.

  • 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.

  • energy performance certificate means a certificate which complies with regulation 6 of the Energy Performance of Buildings (Scotland) Regulations 2008,

  • 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.

  • proof of B-BBEE status level of contributor means:B-BBEE Status level certificate issued by an authorized body or person;A sworn affidavit as prescribed by the B-BBEE Codes of Good Practice;Any other requirement prescribed in terms of the B-BBEE Act;

  • 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;