Significant violations of GMP are published by the US FDA in Warning Letters. The GMP complaints always refer to the relevant section of the American GMP rules CFR 21 Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals. Actually, parts of two Warning Letters address in detail problems in connection with computerised systems. The point of reference 211.68 deals with "Automatic, mechanical, and electronic equipment". 1. Compania Internacional de Comercio, S.A. de C.V. under point 5: Author:
Dr Andreas Mangel
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