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Sistemas de Calidad ISO 9000


 
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¿Deseas obtener, para tu sistema de garantía de calidad GMP, la certificación ISO 9000?
SEV puede ayudarte en la integración de tu sistema de calidad con los requisitos de las normativas ISO 9000, acompañandote en la definición de un plan de acción, la construción del Manual de la Calidad, la creacción de los procedimientos necesarios para la integración y los tramites para obtener la certificación.

Referencias

Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

21 CFR Part 211, Sec 211.63

Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying.

EU GMP, Annex 11, Computerized Systems

The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments.

COMMISSION DIRECTIVE 2003/94/EC, Article 6

It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.

EU GMP, Annex 15, Qualification and validation