(1999; 168 pages) [Spanish]
4. Education and training
The pool of expertise drawn upon for candidates for the position of authorized person may differ from country to country. The basic qualifications of a scientific education and practical experience for key personnel, including authorized persons, are outlined in the GMP guidelines published by WHO (section 10, Personnel).
Additional requirements may include subjects such as principles of quality assurance and GMP, principles of good laboratory practice as applicable to research and development as well as to quality control, detailed knowledge of the authorized/qualified person's duties and responsibilities, of International Standards ISO 9000-9004 and relationships with suppliers, principles and problems of formulation of pharmaceutical preparations, pharmaceutical microbiology, and principles and practice of sampling and testing of starting materials, packaging components and finished dosage forms. For a more detailed list of issues consult the selected references.