(1999; 168 pages) [Spanish]
5. Selected references
Code of practice for qualified persons. In: Rules and guidance for pharmaceutical manufacturers. London, Medicines Control Agency, 1993.
Current good manufacturing practice for finished pharmaceuticals. 21 CFR Part 211.
Current good manufacturing practice in manufacturing, processing, packing or holding of drugs. General. 21 CFR Part 210.
Guideline on preparation of investigational new drug products. March 1991.
Guidelines for developing quality manuals. International Standard ISO 10013. Geneva, International Organization for Standardization, 1995.
Guide to good manufacturing practice for medicinal products. In: The rules governing medicinal products in the European Union, Volume IV. Brussels, European Commission, 1992.
Model for quality assurance in design, development, production, installation and servicing. International Standard ISO 9001. Geneva, International Organization for Standardization, 1994.
Quality management and quality assurance - vocabulary. International Standard ISO 8402. Geneva, International Organization for Standardization, 1994.
Quality management and quality system elements. International Standard ISO 9004. Geneva, International Organization for Standardization, 1994.
Second Council Directive on the approximation of provisions laid down by law: regulation of administrative action relating to proprietary medicinal products. Brussels, European Commission, 1975 (75/319/EEC).