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calibration of instruments and equipment at suitable intervals in accordance with an established documented program. This program should contain specific directions, schedules, limits for accuracy and precision and provisions for remedial action in the event that accuracy and/or precision limits are not met. Calibration standards should be traceable to recognised national or Compendial standards as appropriate.

Instruments and equipment not meeting established specifications should not be used and an investigation should be conducted to determine the validity of the previous results since the last successful calibration. The current calibration status of quality-critical equipment should be known and verifiable to users.

MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General

The organisation should plan and implement the monitoring, measurement and improvement activities required to demonstrate conformity of the excipient to customer requirements and to ensure conformity of the quality management system to this Guide.

The organisation should evaluate opportunities for improvements through the measurement and analysis of product and process trends.

    • 8.2

      Monitoring and Measurement

      • 8.2.1

        Customer Satisfaction

The excipient manufacturer should establish measurement activities to assess customer satisfaction. Such measurements can include customer complaints, return of excipients and customer feedback. This information should drive activities that strive to continuously improve customer satisfaction.

8.2.2

Internal Audit The excipient manufacturer should carry out a comprehensive system of planned and documented internal quality audits. These should determine whether quality activities comply with planned arrangements and the effectiveness of the quality management system. Audits should be scheduled on the basis of the status and importance of the activity. Audits and follow-up actions should be carried out in accordance with documented procedures.

Audit results should be documented and discussed with management personnel having responsibility in the area audited. Management personnel responsible for the area audited should take corrective action on the nonconformities found.

Appendix A, Auditing Considerations will be of assistance in establishing an internal audit program.

8.2.3

Monitoring and Measurement of Processes The excipient manufacturer should identify the tests and measurements necessary to adequately control manufacturing and quality management system processes. Where critical to excipient quality, techniques that are used to verify that the processes are under control should be established.

Corrective action should be taken to ensure the excipient meets requirements when deviations from planned results occur.

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

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