ABSTRACT
Quality Assurance (QA) Systems (sometimes also called “Quality M anagement” in G erm an laws, European Economic Community (EEC), European Commission (EC) and European Union (EU) and other international directives, guidelines and guidances are playing an increasingly im portan t role in the pharm aceutical industry. Legal and o ther prescribed conditions which should be observed, such as EC Good M anufacturing Practice (GMP) direc tives (EC-GMP Directive 1991), O peration O rdinance for Phar maceutical Entrepreneurs Pharm BetrV (B etriebsverordnung fur Pharm azeutische U nternehm er 1994), In ternational Inspection Convention (PIC) Docum ent PH 1/97 , W orld H ealth Organiza tion (WHO) GMP (WHO 1992) and CFR 21 parts 200 to 299 (CFR 21 1998) dem and a QA System that ensures the medicinal product is of the required quality for its in tended use.
