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Quality

Shire is committed to the development, manufacture, assembly, control and distribution of safe and effective pharmaceutical products in compliance with current regulatory requirements.

During the various phases of drug development and drug registration, emphasis will be placed upon quality safety and efficacy assessed from sound scientific data generated in compliance with internationally recognised standards and codes of practice and with the preparation of high quality regulatory dossiers for review by worldwide health authorities.

Robust technology transfer mechanisms will be established and maintained to ensure that products intended for commercial use continue to be manufactured, packaged and controlled using validated processes in qualified environments capable of meeting our high quality standards.

Effective communications will be maintained with our suppliers to enable the timely distribution of products meeting with customer requirements and business objectives.

To achieve these objectives Shire forms strong partnerships with reputable contract research organisations, manufacturing and packaging companies and analytical testing laboratories also committed to the same high quality principles.

Contracts and Technical Agreements will be maintained which clearly define responsibilities in providing assurance that product quality, safety and efficacy will not be compromised whilst operations continue to comply with all regulatory requirements.

To ensure that these quality principles are achieved and maintained Shire will continue to develop effective quality management systems and organisations that are adequately resourced with personnel of the appropriate background, knowledge, training and experience.

Quality standards will be maintained and management responsibilities defined as part of a Group Quality Manual in order to provide guidance in achieving the company’s quality objectives. These will be communicated to all Shire personnel and to the relevant staff located at contractor and supplier organisations.

Shire personnel have a collective responsibility for quality and must comply with the requirements of the Quality Policy and Quality Standards, where applicable, in the performance of their daily duties.

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