current GMP definition

current GMP or “cGMP” means then current Good Manufacturing Practices promulgated by the United States Food & Drug Administration (FDA) and its counterpart governmental agencies in the Territory outside the United States, in the form of laws, regulations or guidance documents, including those practices and standards set forth in Current Good Manufacturing Practice Regulations of the US Code of Federal Regulations Title 21 (21 CFR §§210 and 211) in relation to the production of pharmaceutical products and those practices and standards provided for (as amended from time to time) in the European Community Directive 91/356/EEC, as interpreted by the ICH Harmonized Tripartite Guideline, and any arrangements, additions or clarifications agreed from time to time between the Parties.
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current GMP means the GMP practices in effect at a particular time, including in the United States the requirements set forth in the FDA's current Quality System Regulation, as it may be amended from time to time.
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current GMP means current good manufacturing practices as determined by the World Health Organization;
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Examples of current GMP in a sentence

  • These records will be stored by appropriate means, including without limitation, optical disk or microfilm in a secure manner in compliance with current GMP with duplicate copies submitted to CUMBERLAND promptly after the creation thereof and shall be made available on request of the FDA or any other authorized regulatory body.

  • Each person engaged in the manufacture, packaging, testing, storage, and shipping of the Product will have the education, training, and experience necessary, consistent with current GMP and safety training requirements.

  • The Products sold by the Business during the Relevant Period have complied in all material respects with all applicable product specifications and have been Manufactured in all material respects in accordance with applicable requirements of then current GMP and any Applicable Law, except for any such non-compliance that is not, and would not reasonably be expected to have, a materially adverse impact on the relevant Product.

  • All the documents must be archived according to manufacturer’s and/or CTSU SOPs and current GMP.

  • The CTSU out source, manufacture and pack the IMP in accordance with current GMP.

  • All Product supplied by Spolana shall be manufactured in accordance with current GMP manufacturing and record keeping procedures and ISO 9000 regulatory requirements and record keeping procedures at Spolana's plant located at 27711 Neratovice, Czech Republic (the "Facility").

  • The Parties note that the current GMP requirements for veterinary medicinal products in Australia are not equivalent to those that apply in the European Community.

  • It is understood that as of the Effective Date Vivus has engaged Forum (Holdings) Limited ("Forum") pursuant to that certain agreement dated September 26, 1996 pursuant to which Forum agreed to assist Vivus in ensuring, by aiding Spolana, that Spolana meets and maintains current GMP and requirements necessary for the sale of Product throughout the world.

  • Antibody Raw Material, in the case of the Manufacturing Lead, and Antibody Products in Finished Form, in the case of Amgen, shall be manufactured in accordance with current GMP in manufacturing processes and facilities as described in the applicable Regulatory Filings submitted to and approved by the Regulatory Authority.

  • Subject to ¶¶ V(B)(4)(a) and (d) herein, the Design-Builder may adjust individual line-items to reflect actual costs incurred in performing the Work provided that other line-items are commensurately adjusted in order to maintain the then- current GMP.


More Definitions of current GMP

current GMP means the GMP practices in effect at a particular time.
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current GMP or “cGMP” means then current Good Manufacturing Practices promulgated by the United States Food & Drug Administration (FDA) or its counterpart governmental agencies in the Territory in the form of laws, regulations or guidance documents.
View Source