GMP Guidelines definition

GMP Guidelines means then-current applicable Good Manufacturing Practices guidelines and regulations of the FDA.
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GMP Guidelines means Volume 4 of the Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Process for Medicinal Products for Human and Veterinary Use.
Sample 1

Examples of GMP Guidelines in a sentence

  • Talecris GmbH shall provide to Xxxxx a written report for each production batch (each a “Manufacturing Record”) for the purpose of complying with the registration and the documentation requirements of applicable Regulations, including without limitation, ED GMP Guidelines and of ED directive 91/356 article 9, as each may be amended from time to time, and any successors thereto.

  • IDENIX and NOVARTIS are defining their roles and responsibilities according to the intentions of the EU/PIC GMP Guidelines.

  • This QTA must be modified if any item fails to meet future revisions of US 21 CFR Part 11 and Parts 210 and 211, Canadian Good Manufacturing Practices (GMP) Guidelines 2009 Edition (GUI-0001) and EU Directives including Volume IV of the rules governing medicinal products in the European Community, and other applicable regulations and guidelines, if revisions to this QTA are required other than to the Contact List (Appendix 2) both parties must approve changes in writing.

  • MANUFACTURING GMP COMPLIANCE 2 5.1 General 2 5.2 Premises 2 5.3 GMP Guidelines 3 5.4 Materials 3 5.5 Master Production Records 4 5.6 Standard Operation Procedures and documentation 4 5.7 Methods Validation/Certification 4 5.8 Batch Numbers 4 5.9 Dates of Manufacture and Expiration 4 5.10 Manufacturing and Equipment Data 5 5.11 Storage and Shipment 5 6.

  • MANUFACTURING GMP COMPLIANCE 2 5.1 General 2 5.2 Premises 2 5.3 GMP Guidelines 2 5.4 Materials 2 5.5 Materials procured by ORPHAN 3 5.6 Materials Provided by ORPHAN for LONZA 3 5.7 Master Production Records 3 5.8 Standard Operating Procedures 3 5.9 Methods Validation 4 5.10 Batch Numbers 4 5.11 Dates of Manufacture and Expiration 4 5.12 Manufacturing and Equipment Data 4 5.13 Storage and Shipment 5 6.

  • All Ingredient manufactured by Can-Fxxx or its contract manufacturers for SKK under the Supply Agreement will be manufactured in accordance with the Specifications (which will include reference to the then-current good manufacturing practices under the rules and regulations of the FDA or such other rules as updated by ICH GMP Guidelines and regulations in the Territory).

  • SUPPLY 5 9.1 Premises 5 9.2 API Specification and Master Production Records 5 9.3 GMP Guidelines 6 9.4 Materials 6 9.5 Master Production Record Approval 7 9.6 Production 7 9.7 Methodology 7 9.8 Standard Operating Procedure 7 9.9 Dates of Manufacture and Expiration 7 9.10 Manufacturing and Equipment Data 7 10.

  • FG represents and warrants that the Lead Compounds to be supplied to Astellas under this Agreement shall conform to the Product Specifications and shall, as appropriate, be manufactured in compliance with GMP Guidelines.

Related to GMP Guidelines

  • 2%/25% Guidelines has the meaning set forth in Section 13.

  • Program Guidelines means any and all GLO-approved documents reflecting specific rules and regulations governing the implementation of the Program.

  • ECB €STR Guideline means Guideline (EU) 2019/1265 of the European Central Bank of 10 July 2019 on the euro short-term rate (€STR) (ECB/2019/19), as amended from time to time;

  • Design Guidelines means the Fernkloof Estate architectural design guidelines to control all aspects of design and landscaping of any development within the Fernkloof Estate dev elopment, as amended from time to t ime in terms of the constitution of the MPOA or as required by the Council , a copy of the current draft which i s av ailable for inspection at the offices of the Association;

  • Procurement Guidelines means the “Guidelines: Procurement under IBRD Loans and XXX Credits” published by the Bank in May 2004 and revised in October, 2006.

  • Applicable Guidelines means the policies of the Bank governing the selection and Contract award process as set forth in this RFP.

  • Guidelines means the Instructions to Authors available on the Xxxxxxx Science website, as well as the Aims & Scope applicable to the relevant Xxxxxxx Science publication). Xxxxxxx Science’s nominated service provider, Xxxxxxx Science, offers English language support services which Assignor may elect to utilise in respect of the Work by completing the applicable box in Schedule 1: Details of the Work. The provision of such services by Xxxxxxx Science shall be subject to Xxxxxxx 2 [v.122016] Science’s prevailing terms and rates relating to such type of optional support.

  • Operating Guidelines means the guidelines for the creation and redemption of Units of a class as set out in the schedule to each Participation Agreement as amended from time to time by the Manager with the approval of the Trustee, and where applicable, with the approval of HKSCC and the Conversion Agent, and following consultation, to the extent reasonably practicable, with the relevant Participating Dealers subject always, in respect of the relevant Operating Guidelines for a Participating Dealer, any amendment being notified in writing by the Manager in advance to the relevant Participating Dealer. Unless otherwise specified, references to the Operating Guidelines shall be to the Operating Guidelines for the relevant Sub-Fund applicable at the time of the relevant Application.

  • Federal poverty guidelines means the poverty guidelines published annually in the Federal Register by the United States Department of Health and Human Services under its authority to revise the poverty line under section 673(2) of subtitle B of title VI of the omnibus budget reconciliation act of 1981, 42 USC 9902.

  • Fitch Guidelines means the guidelines, as may be amended from time to time, in connection with Fitch’s ratings of the VMTP Shares.

  • Modification Guidelines has the meaning provided in Section 2.1(a) of this Single Family Shared-Loss Agreement.

  • Consultant Guidelines means the “Guidelines: Selection and Employment of Consultants by World Bank Borrowers” published by the Bank in May 2004 and revised in October 2006.

  • Valuation Guidelines means the valuation guidelines adopted by the Board, as amended from time to time.

  • Treasury guidelines means any guidelines on supply chain management issued by the Minister in terms of section 168 of the Act;

  • User Guide means such user guide or document issued or prescribed by us, through any medium, setting out instructions on the use of the EB Services;

  • Investment Guidelines means the investment guidelines approved by the Board, a copy of which is attached hereto as Exhibit A, as the same may be amended, restated, modified, supplemented or waived pursuant to the approval of a majority of the entire Board (which must include a majority of the Independent Directors).

  • Program Guide The Residential Funding Seller Guide for mortgage collateral sellers that participate in Residential Funding's standard mortgage programs, and Residential Funding's Servicing Guide and any other subservicing arrangements which Residential Funding has arranged to accommodate the servicing of the Mortgage Loans.

  • Consulting Guidelines means the Guidelines on the Use of Consultants by Asian Development Bank and its Borrowers (2010, as amended from time to time);

  • Credit Guidelines means the policies of Credit Acceptance, relating to the extension of credit to automobile, light-duty truck, minivan and/or sport utility dealers and consumers in respect of retail installment contracts for the sale of automobiles, light-duty trucks, minivans and/or sport utility vehicles including the policies for determining creditworthiness of such dealers and consumers and otherwise relating to the extension of credit to dealers and consumers and the maintenance of installment sale contracts, as in effect on the Cut-off Date and as amended from time to time in accordance with the Basic Documents or in accordance with Applicable Law, attached hereto as Exhibit H.

  • User Guides means Sprinklr materials made available to Customer through the support portal to assist users of the Platform, as such materials may be updated during the Term.

  • Bidding Guidelines means the “Tariff Based Competitive-Bidding Guidelines for Transmission Service” and “Guidelines for Encouraging Competition in Development of Transmission Projects” issued by Government of India, Ministry of Power dated 13th April 2006 under Section – 63 of Electricity Act and as amended from time to time;

  • Anti-Corruption Guidelines means the “Guidelines on Preventing and Combating Fraud and Corruption in Projects Financed by IBRD Loans and XXX Credits and Grants”, dated October 15, 2006.

  • Environmental Guidelines means the environmental guidelines and occupational health and safety standards of the World Bank Group as in effect on [Bid Date].

  • Program Requirements means that Partner has to fulfill certain program requirements as described in detail in the applicable SAP PartnerEdge Model and the PartnerEdge Program Guide.

  • Policies and Procedures means the written policies and procedures of the Client in any way related to the Services, including any such policies and procedures contained in the Organic Documents and the Offering Documents.

  • Rating Agency Guidelines means the Fitch Guidelines and any Other Rating Agency Guidelines as they exist from time to time.