GMP Guidelines definition

GMP Guidelines means then-current applicable Good Manufacturing Practices guidelines and regulations of the FDA.
View Source
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.
View Source

Examples of GMP Guidelines in a sentence

  • Talecris GmbH shall provide to ▇▇▇▇▇ 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.

  • 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.

  • 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.

  • 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.

  • All Ingredient manufactured by Can-F▇▇▇ 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).

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;

  • Poverty guidelines means the poverty guidelines for the 48 contiguous states and the District of

  • 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;