The European Commission (EC) Directive, which sets forth the principles and guidelines of GMP for m edicinal products for hum an use (91/356 /E E C ), states in Article 6, “Quality Manage­ m ent”, “The m anufacturer shall establish and implement an effec­ tive pharm aceutical quality assurance system, involving the active participation o f the managem ent and personnel of the different services involved”. In the Code o f Federal Regulations (CFR), the U.S. counterpart o f EC Directives, there is no explicit requirem ent for such a quality system, but companies must nonetheless estab­ lish a system which assures the production of quality.