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An organisation chart by function should show inter-departmental relationships as well as relationships to top management of the company. Personnel who have an impact on excipient quality should have job descriptions.

5.5.2

Management Representative The excipient manufacturer should appoint a management representative with sufficient authority to ensure that the provisions of this Guide are properly implemented. The representative should periodically report to top management on conformance to the quality management system, including changing customer and regulatory requirements.

5.5.3

Internal Communication The excipient manufacturer should ensure appropriate systems are established to communicate GMP and regulatory requirements, quality policies, quality objectives and procedures throughout the organisation. The communication should also provide information about the effectiveness of the quality management system.

Top management should be notified in a timely manner of quality-critical situations, such as product retrievals, in accordance with a documented procedure.

    • 5.6

      Management Review

      • 5.6.1

        General

The top management of the company should hold periodic reviews of the quality management system to confirm the organisation’s continued conformance to this Guide.

The review should be recorded and include assessing opportunities for improvement and the need for changes to the quality management system.

5.6.2

Review Input Management review inputs should include for example:

    • results of internal and external audits,

    • customer feedback of the company performance,

    • product conformity and process performance,

    • action items from the previous management review,

    • customer complaints,

    • status of corrective or preventive actions,

    • changes that could affect the quality management system.

      • 5.6.3

        Review Output

The management review should identify the resources needed and opportunities presented for improvement of the quality management system and improvement of product conformance to customer and regulatory requirements. A record should be made of actions recommended and taken.

RESOURCE MANAGEMENT 6.1 Provision of Resources

There should be sufficient qualified personnel and resources (for example equipment, materials, buildings and facilities) to implement, maintain and improve the quality management system and to produce, package, test, store and release each excipient in a manner consistent with this Guide.

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

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