Quality Design of Medicinal Products in Light of Current European Community Regulations

Quality in pharmaceutical development follows European Community (EC) directives and their associated guidelines with the aim of establishing documentation for chemical, pharmaceutical, and biological tests for marketing authorization in accordance with Part II of the Notice to Applicants. The quality concept is introduced as early as possible in the development process (eg, preclinical and clinical trials). An international pharmaceutical company develops quality into a product taking into consideration regulations outside of the EC community such as the quality standards of the United States, Japan, and World Health Organization (WHO) in order to guarantee quality on a worldwide basis. Therefore, international harmonization is needed for the concept of quality design during development and the results must be incorporated in the registration documents for international use. Many ideas within the International Council on Harmonization (ICH) procedures are being looked at and some further aspects need to be harmonized, such as the documentation of the manufacturing procedure and quality/process controls during the manufacturing of a new drug substance. In addition to the regulations for setting up the quality documentation to be submitted to the registration authorities, drug substances and drug products have to be manufactured in accordance with good manufacturing practices (GMP) throughout the development phases of the clinical trials. To guarantee these requirements, accompanying GMP aspects have to be considered, such as the quality assurance system, premises and equipment, sanitation and hygiene, the validation concept, and documentation. The pharmaceutical companies located in Europe have to follow primarily ECGMP regulations but also have to consider other GMP guidelines (eg, WHO, US, and Japan) insofar as their drug products are exported to countries outside of Europe. Many GMP aspects in the existing guidelines are comparable but there is a need for harmonization to some extent. Besides the GMP regulations in the pharmaceutical field, the Commission European de Normalisation Electrique (CEN/CENELEC) Common Rules (Deutsche Industrie Norm [DIN] ISO 9000–9004 and EN 29000–29004) should be investigated with a view to adoption by the pharmaceutical sector within the framework of overall harmonization.