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be derived from customer complaints, product reviews, process capability studies, internal and customer audits. The analysis of such data may be used as part of the management review (see also 5.6).

A periodic review of key indicators such as product quality attributes, customer complaints and product nonconformities may be conducted to assess the need for improvements.

    • 8.5

      Improvement

      • 8.5.1

        Continual Improvement

The excipient manufacturer should take proactive measures to continuously improve manufacturing and quality management system processes. To identify opportunities for continual improvement, analysis of the following performance indicators may be considered:

    • causes of nonconforming product,

    • results of internal and external audits,

    • customer returns and complaints,

    • process and operational failures.

      • 8.5.2

        Corrective Action

The excipient manufacturer should establish, document and maintain procedures for:

    • determining the root causes of nonconformities,

    • ensuring that corrective actions are implemented and effective,

    • implementing and recording changes in procedures resulting from corrective action.

      • 8.5.3

        Preventive Action

The excipient manufacturer should establish, document and maintain procedures for:

  • initiating preventive actions to deal with problems at a level corresponding to the

risks,

  • implementing and recording changes in procedures resulting from preventive action.

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

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