EU cGMP definition

EU cGMP means the current Good Manufacturing Practices as set out in Directive 2003/94 as effective of Nov. 2003, of the Commission of the European Communities and further elaborated in The Rules Governing Medicinal Products in the European Community, Volume IV - Guide to Good Manufacturing Practice for Medicinal Products, Contract Manufacture and Analysis, as such may be amended from time to time.
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EU cGMP has the meaning set forth in Section 1.16 (“cGMP”).
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Examples of EU cGMP in a sentence

  • BDU Biotherapeutics Development Unit CA Contract Acceptor CG Contract Giver GMP Good Manufacturing Practice EU European Union EU GMP European Union current Good Manufacturing Practice as defined in directive 2003/94/EC IMP Investigational Medicinal Product = drug product (unless otherwise stated IMP means manufactured to EU cGMP or its equivalent) MCB [***] QP Qualified Person Retention A sample of a packaged unit from a batch of finished sample product for each packaging run/trial period.

  • Kamada shall comply in all material respects with all Applicable Laws and Guidelines applicable to the design, manufacture, labeling, packaging, storage, testing, release, shipping and handling of the Product in the Territory, including maintaining qualified manufacturing and quality facilities and/or procedures in accordance with EU cGMP pharmaceutical standards.

  • Products shall be supplied to DISTRIBUTOR accompanied by the appropriate certificate of analysis, attesting that the Products have been manufactured and tested in compliance with the EU cGMP requirements and with the related Marketing Authorizations as known to BIOCODEX.

  • The PQR will be for a twelve (12) month period and contain, at the minimum, the contents required by the [EU cGMP Guidelines][FDA cGMP].