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5.3 Quality Policy

Top management should demonstrate its commitment to the corporate quality policy and ensure that it is implemented within the operational unit. The quality policy should support continual improvement of the quality management system. Management should participate in the development of the company's quality policy and provide the resources necessary for its development, maintenance and deployment.

    • 5.4

      Planning

      • 5.4.1

        Quality Objectives

Top management should set objectives for adherence to GMP to ensure that the excipient manufacturer maintains and improves its performance. Objectives should be deployed throughout the organisation and should be measurable and consistent with the quality policy.

5.4.2

Quality Management System Planning Top management should provide adequate resources to ensure conformance to the provisions of this Guide. There should be a process for the identification of resources needed for adherence to GMP. A gap analysis based on audits by internal personnel, customers, regulatory agencies or outside contractors and this Guide could be used for the purpose of identifying resource requirements.

Top management should ensure that the integrity of the quality management system is maintained when changes are planned and implemented.

5.5 Responsibility, Authority and Communication

5.5.1

Responsibility and Authority Responsibility and authority should communicated within the organisation.

be

clearly

defined

by

top

management

and

It should be the responsibility of a unit independent of production, such as the quality unit, to:

  • ensure quality-critical activities are undertaken as defined,

  • approve suppliers of quality-critical materials and services,

  • approve or reject raw materials, packaging components, intermediates and finished excipients,

  • ensure that there is a review of production records to ensure that no errors have occurred or, if errors occur, that they are fully investigated,

  • participate in reviewing and authorising changes to processes, specifications, procedures and test methods that potentially affect quality (see also 4.3) and in investigating failures and complaints,

  • retain responsibility for approval or rejection of the excipient if it is produced, processed, packaged or held under contract by another company,

  • develop and implement a self inspection programme of the quality management system.

The excipient manufacturer may delegate some of the quality unit’s activities to other personnel if appropriate controls (for example periodic audits, training and documentation) are in place.

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

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