cGMP Requirements definition

cGMP Requirements means the FDA’s current good manufacturing practice requirements as promulgated under the FFDCA at 21 C.F.R. (parts 11, 210 and 211), and as further defined by FDA guidance documents, as such may be amended from time to time.

cGMP Requirements means the current Good Manufacturing Practices standards required under ICH Q7A guideline and/or any similar standards of applicable governmental and/or regulatory authorities as defined in the Quality Agreement;

cGMP Requirements means the requirements of cGMP.

Examples of cGMP Requirements in a sentence

• The Manufacturer shall use commercially reasonable efforts to assist the Company, during the Term to (i) locate and qualify a new supplier of API that meets cGMP Requirements, the API Specifications and applicable Law (“Compliant API”) for the Products and (ii) provide such documents and take such other actions as are necessary to allow the Company to list and obtain FDA approval for the new supplier as an alternate supplier of API in the NDA.

• Supplier shall ensure that all Product held in storage is stored in accordance with the Product Specifications until shipped to Customer under this Agreement and that all storage areas meet cGMP Requirements.

• Manufacturer shall maintain traceability records in accordance with the applicable Governmental Rules, including cGMP Requirements, and in accordance with any written instructions or guidelines provided to Manufacturer by the Buyer, necessary to permit a recall, field correction or other notification to the field, of the Supply Products.

• Supplier shall maintain adequate books and records and retention samples consistent with cGMP Requirements and any other Applicable Law and requirements of applicable governmental or regulatory authorities, in respect of test records, samples and associated support data for all batches of Product Manufactured by Supplier sufficient to substantiate and verify Supplier’s duties and obligations under this Agreement for [* * *] from the expiration date of the respective Product batch.

• All Supply Products delivered pursuant to this Supply Agreement by the Manufacturer (or any sub-contractor thereof) to the Buyer or its designee during the Term will at shipment be in compliance in all material respects with this Supply Agreement, the Specifications, the Quality Agreement and applicable Governmental Rules, including the cGMP Requirements, and the Manufacturing of such Supply Products will have been in accordance with the cGMP Requirements.

More Definitions of cGMP Requirements

cGMP Requirements means the current Good Manufacturing Practices standards required by the FDA (as set forth in the FDCA), the Therapeutic Products Directorate Organization of Health Canada ("TPD"), and the European Medicines Evaluation Agency ("EMEA") and any other jurisdiction as mutually agreed between the Parties together with their applicable regulations, policies or guidelines which are in effect for the manufacture and testing of pharmaceutical materials, active ingredients, or excipients for use in Phase I, Phase II, and Phase III clinical trials, as applicable.

cGMP Requirements means the current Good Manufacturing Practices standards required by the FDA, the Therapeutic Products Directorate Organization of Health Canada ("TPD") and the equivalent Regulatory Authority(ies) elsewhere in the Territory, and the applicable regulations, policies or guidelines of each of them in effect for the manufacture and testing of pharmaceutical materials, active ingredients, or excipients, as applicable.

cGMP Requirements means both CGMP and the CGMP provisions of this Decree.

cGMP Requirements means the FDA’s current Good Manufacturing Practice requirements as promulgated under the FFDCA at 21 CFR (Parts 210 and 211), CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT MARKED [***] HAVE BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION. and as further defined by FDA guidance documents, as such may be amended from time to time, applicable to the Manufacturing, processing and packaging of the Products.

cGMP Requirements means the requirements of the US CGMP.

cGMP Requirements means: the current Good Manufacturing Practices standards required under ICH Q7 guideline;

cGMP Requirements means those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices, including, without limitation, each of the following as in effect on the Effective Date of this Agreement and as amended or revised from time to time thereafter: (a) the FDA Act, including 21 C.F.R. parts 11, 210 and 211, and other FDA regulations, policies and guidelines governing the manufacturing, testing, storage and/or quality control of active pharmaceutical ingredients for use in human drug pharmaceutical products; and (a) all ICH guidance documents as appropriate, including EU Directives 2003/94IEC code of GMP and 2001/83IEC as amended by 2004/27/EC code of practice for the QP, and ICH Tripartite Guidance Q7A entitled “ICH Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”, as applied to active pharmaceutical ingredients for use in human drug pharmaceutical products.