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Regulatory Focus™ > News Articles > Quality & Compliance: CGMP 101

Quality & Compliance: CGMP 101

Posted 01 May 2009 | By William Lappenbusch, PhD, RAC

In the lab, I have experienced numerous satisfying moments producing "pure" chemical compounds as judged by thin-layer chromatography, nuclear magnetic resonance and mass spectrometry. Purity of 100% was elusive due to impurity detection limits, but synthesizing beautiful white powders, clear crystals and oily goos was nonetheless gratifying once "clean" spectra were obtained. While the identities of these compounds were certain in my mind, all would have failed the standards of Good Manufacturing Practices (GMP) miserably. Even if elemental analyses and high-resolution mass spectra had confirmed the proposed chemical structures, agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMEA) and Health Canada's Health Products and Food Branch (HPFB), would consider them adulterated. Current GMP (CGMP) philosophy requires excellence in every step in the creation of drugs or biologics. Verification of endproduct identities and purities is essential, but only one part of the GMP process.

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