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GMP guidelines are essential to ensure drugs are produced to a consistently high quality. There is a risk that poor quality and substandard pharmaceuticals EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Volume 4 of "The rules governing medicinal products in the European Union" contains 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. In 1992, the revised draft requirements for GMP were presented in three WHO guidelines for medicines quality assurance, quality control (QC).