Applicable GMP Standard Sample Clauses

Applicable GMP Standard. Supplier shall manufacture all products manufactured for Client (listed in Appendix 2) in compliance with current Good Manufacturing Practices (cGMP). For the purposes of this agreement; cGMP shall mean the principles (i) described in the ICH Q7 and FDA CFR 21 Parts 11 and 211, and (ii) promulgated by any Governmental Authority having jurisdiction over the manufacture of all products manufactured for Client, in the form of laws or guidance documents, where the guidance documents are to be implemented within the pharmaceutical manufacturing industry for such products.
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
Applicable GMP Standard. SUPPLIER shall manufacture the SUBSTANCE(s) listed in Appendix X in compliance with the ICH Q7 Guide.
Sample 1
Applicable GMP Standard. Euticals shall manufacture the SUBSTANCE(s) listed in section I.2 in compliance with the ICH Q7 Guide Directive 2001/83/EC and amendments of the European Union together with its Guidelines “The Rules governing medicinal products in the European Union, Volume IV – Good Manufacturing Practice (“GMP”) for medical products, the Guidelines on Principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use (2015/C 95/01) (“GDP”) and as Switzerland is concerned the Federal Act on Therapeutic Products (Heilmittelgesetz, HMG; SR 812.21) the Ordinance on Establishment Licences (Arzneimittel-Bewilligungsverordnung, AMBV; SR 812.212.1)
Sample 1
Applicable GMP Standard. SUPPLIER shall manufacture the PRODUCT in compliance with United States (US) 21 Code of Federal Regulations (CFR) Part 210 and 211 and guidance(s); United States Pharmacopeia (USP) Convention, International Conference on Harmonization, and Division 2 of Part C of the Food and Drug Regulations (Canada) together with the latest Health Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time and as interpreted by relevant ICH guidelines. General Considerations Any communications about the subject matter of this Agreement will be directed, in the first instance, to the person(s) identified in Section 23. If any provision of this Agreement should be or found invalid, or unenforceable by law, the rest of the Agreement will remain valid and binding and the parties will negotiate a valid provision which meets as close as possible the objective of the invalid provision. If this Agreement requires modification such that either party affected cannot be reasonably expected to continue to perform under this Quality Agreement, then the parties will negotiate and revise the Quality Agreement accordingly. Any revision of this Quality Agreement will be made in writing and signed by both parties.
Sample 1
Applicable GMP Standard. CONTRACT ACCEPTOR shall manufacture the SUBSTANCE(s) listed in Appendix X in compliance with cGMP.
Sample 1
Applicable GMP Standard. HOVIONE shall manufacture the Product in compliance with current Good Manufacturing Practices of all applicable health authorities including without limitation, the FDA applicable rules, regulations, guides and guidance, such as 21 CFR Parts 11, 210-211, the EU GMP Guide Part I and/or Part II and respective guidance documents and ICH respective guidance including but not limited to ICH Q7 and legislation of other countries, as applicable.
Sample 1

Related to Applicable GMP Standard

  • Applicable Standards The requirements and guidelines of NERC, the Applicable Regional Entity, and the Control Area in which the Customer Facility is electrically located; the PJM Manuals; and Applicable Technical Requirements and Standards.

  • Meets Standard The school materially complies with applicable laws, rules, regulations and provisions of the charter contract relating to financial reporting requirements, including but not limited to: • Complete and on-time submission of financial reports, including annual budget, revised budgets (if applicable), periodic financial reports as required by the authorizer and any reporting requirements if the board contracts with an Education Service Provider (ESP) • On-time submission and completion of the annual independent audit and corrective action plans, if applicable • No charging of tuition • Adequate management and financial controls • All reporting requirements related to the use of public funds Measure 2b Is the school following Generally Accepted Accounting Principles (GAAP)?

  • Service Level Standards In addition to all other requirements in this Agreement, and in accordance with the Best Claims Practices & Estimating Guidelines, Vendor shall use reasonable and good faith efforts to meet the Service Level Standards set forth below.

  • Policies, Guidelines, Directives and Standards Either the LHIN or the MOHLTC will give the HSP Notice of any amendments to the manuals, guidelines or policies identified in Schedule C. An amendment will be effective in accordance with the terms of the amendment. By signing a copy of this Agreement the HSP acknowledges that it has a copy of the documents identified in Schedule C.

  • Conformance to Applicable Requirements All work prepared by Consultant shall be subject to the approval of City.

  • Standards Compliance DNS. Registry Operator shall comply with relevant existing RFCs and those published in the future by the Internet Engineering Task Force (IETF), including all successor standards, modifications or additions thereto relating to the DNS and name server operations including without limitation RFCs 1034, 1035, 1123, 1982, 2181, 2182, 2671, 3226, 3596, 3597, 4343, and 5966. DNS labels may only include hyphens in the third and fourth position if they represent valid IDNs (as specified above) in their ASCII encoding (e.g., “xn--ndk061n”).

  • Accounting System Requirement The Contractor shall maintain an adequate system of accounting and internal controls that meets Generally Accepted Accounting Principles or “GAAP.”

  • Child Abuse Reporting Requirement Grantee will:

  • Standards Any additions, modifications, or replacements made to a Party’s facilities shall be designed, constructed and operated in accordance with this Agreement, NYISO requirements and Good Utility Practice.

  • DBE/HUB Compliance The Engineer’s subcontracting program shall comply with the requirements of Attachment H of the contract (DBE/HUB Requirements).

Time is Money Join Law Insider Premium to draft better contracts faster.