cGMP Compliance. The principles detailed in the US Current Good Manufacturing Practices (21 CFR 200, 211, and 600) and “The Rules Governing Medicinal Product in The European Community—Volume IV Good Manufacturing Practice for Medicinal Products” CGMP Guidelines will cover the standards of QC for the PRODUCTS, including the product specifications and any applicable product license or pharmacopoeia or formulatory requirements.
cGMP Compliance. In the event of any audit of Supplier's --------------- compliance with CGMP, GWI shall submit to Supplier a written report of GWI's findings within thirty (30) days of completion of the audit. Within thirty (30) days after receipt of this report, Supplier shall submit its written response to the report.
cGMP Compliance. Where the German Pharmaceuticals Act, the German Regulation for Manufacturing of Medicinal Products and Active Ingredients and the Guidelines to Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use of the European Union (“EU cGMP Guidelines”) or the applicable Purchase Order or other Applicable Law requires Xxxxxxxxxx to do so, Xxxxxxxxxx shall comply with cGMP as regulated under the EU cGMP Guidelines and under Title 21, Parts 210, 211, 600 and 610 of the Code of Federal Regulations of the United States of America, as amended from time to time, and the International Committee on Harmonization and other comparable guidelines, directives or standards required by governmental authorities in the United States and European Union. If Customer requests Xxxxxxxxxx to comply with cGMP as regulated under other jurisdictions, Customer will provide Xxxxxxxxxx with information required to comply with such cGMP rules and the Parties will mutually agree prior to the Manufacture of Product under such cGMP rules, if and how the additional requirement can be met.
cGMP Compliance. AMSINO shall Manufacture the Product in accordance with the Specifications, with applicable cGMP’s and with such other applicable laws and regulations as shall be set forth in the Quality Agreement.
cGMP Compliance. SELLER shall develop, manufacture, assemble and package the Device in accordance with the Device Specifications and applicable cGMP.
cGMP Compliance. Organichem shall at all times maintain its facility for the production of API in compliance with cGMP, the FD&C Act, all FDA Rules and the DMFs. Organichem shall at all times manufacture API in compliance with cGMP, the FD&C Act, all FDA Rules and the DMFs.
cGMP Compliance. All manufacturing under this Agreement will be conducted in accordance in all respects with cGMP;
cGMP Compliance. SMITHS shall Manufacture the Product in accordance with the Specifications, with applicable cGMP’s and with such other applicable laws and regulations as shall be set forth in the Quality Agreement.
cGMP Compliance. Manufacturer agrees that all Products made hereunder shall be manufactured in accordance with cGMP Compliance standards. In particular, Manufacturer agrees to comply with cGMP batch record keeping standard as set forth by German Good Manufacturing Practice standards for foodstuffs. The Parties agree the resulting Product or Blended Product shall also be in specific compliance with the standards set forth in Exhibits C and D, respectively.
cGMP Compliance. 5.3 Master Controlled Documents 5.4 Variance Investigations 5.5 Lot Disposition 5.6 Product Complaints 5.7 Product Recalls
