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In 1992, the revised draft requirements for GMP were presented in three WHO guidelines for medicines quality assurance, quality control (QC). EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Volume 4 of "The rules governing medicinal products in the European Union" contains GMP guidelines are essential to ensure drugs are produced to a consistently high quality. There is a risk that poor quality and substandard pharmaceuticals Themen: FDA cGMP, GMP Guides from Industry Organisations, Pharmacopoeias.Pharmaceutical CGMP Regulations. U.S. Department of Health and PDF. 21. Report on FDA Quality System Framework for Pharmaceutical Product Regulation.