The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations


Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,

This guidance describes a comprehensive quality systems model, which, if implemented, will allow manufacturers to support and sustain robust, modern quality systems that are consistent with CGMP regulations

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