(1999; 168 pages) [Spanish]
2. Implementation of the quality system
Authorized persons have a personal and professional responsibility for ensuring that each batch of finished products has been manufactured in accordance with the marketing authorization, GMP rules and all related legal and administrative provisions. This does not necessarily mean that they must have directly supervised all manufacturing and quality control operations. They must be satisfied either directly or, more usually, by proper operation of quality systems, that manufacturing and testing have complied with all relevant requirements. Therefore it is recommended that the manufacturer establishes and maintains a comprehensive quality system, covering all aspects of GMP.
Useful reference material, in addition to rules and regulations on GMP, may be found in the International Standards ISO 9000 family (9000-9004). These standards describe quality systems requirements that can be used for external quality assurance purposes. The important element of these documents is a quality manual, describing the quality policy and objectives (commitment to quality) of the company, the organizational structure, responsibilities and authorities, together with a description of or references to documented quality system procedures.
Research and development activities and the transfer of results of the developmental work to routine manufacture, including original product design, formulation, processes development and validation, should observe GMP principles as guidance. Batches produced for clinical trials must follow applicable GMP. It is of vital importance that the quality of routine production batches corresponds to a specification derived from the composition of development batches. The quality and safety of a pharmaceutical product depend on the application of appropriate procedures, based on GMP, leading to a product within the recognized specification. Standard procedures and recognized specifications cannot be separated.