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.
Applicable GMP Standard. SUPPLIER shall manufacture the SUBSTANCE(s) listed in Appendix X in compliance with the ICH Q7 Guide.
Applicable GMP Standard. CONTRACT ACCEPTOR shall manufacture the SUBSTANCE(s) listed in Appendix X in compliance with cGMP.
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.
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.
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)
