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There should be a documented procedure defining how the retrieval of an excipient from distribution should be conducted and recorded.

Procedures should exist for the evaluation and subsequent disposition of nonconforming products. Nonconforming product should be reviewed in accordance with documented procedures to determine if it may be:

  • reprocessed/reworked to meet the specified requirements,

  • accepted by the customer with their agreement,

  • re-graded for other applications,

  • destroyed.

      • 8.3.1


Repetition of an activity that is a normal part of the manufacturing process (reprocessing) should only occur when it has already been documented that the excipient may be made in that manner. In all other cases, the guidance for reworking should be followed.


Reworking An activity that is not a normal part of the manufacturing process (reworking) should only be conducted following a documented review of risk to excipient quality and approval by the quality unit. As appropriate, when performing the risk assessment, consideration should be given to:

  • new impurities that may be introduced as a result of reworking,

  • additional testing to control the reworking,

  • records and traceability to the original batches,

  • suitable acceptance criteria for the reworked excipient,

  • impact on stability or the validity of the re-evaluation interval,

  • performance of the excipient.

When the need to rework an excipient is identified an investigation and evaluation of the cause is required.

The equivalence of the quality of reworked material to original material should also be evaluated and documented to ensure that the batch will conform to established specifications and characteristics.

Batches of excipients that do not conform to specifications individually must not be blended with other batches that do conform in an attempt to hide adulterated or sub- standard material.


Returned Excipients Returned excipients should be identified and quarantined until the quality unit has completed an evaluation of their quality. There should be procedures for holding, testing reprocessing or reworking of the returned excipient. Records for returned products should be maintained and should include the name of the excipient and the batch number, reason for the return, quantity returned and ultimate disposition of the returned excipient.

8.4 Analysis of Data

The excipient manufacturer should develop methods for evaluating the effectiveness of its quality management system and use those data to identify opportunities for improvement. Such data can

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

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