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Periodic reviews of key indicators such as process quality attributes and process failures should be conducted to assess the need for improvements.

Monitoring and Measurement of Product The excipient manufacturer should establish the test methods and procedures to ensure the product consistently meets specifications.

Analytical methods should be fit for purpose. The analytical methods may be those included in the current edition of the appropriate pharmacopoeia or another accepted standard. However, the methods may also be non-Compendial.

If the excipient manufacturer claims that their product is in compliance with a pharmacopoeia or an official compendium, then:

    • non-Compendial analytical tests should be demonstrated to be equivalent to those in the compendia,

    • it should comply with applicable general chapters and notices.


          Laboratory Controls

Laboratory Controls should include complete data derived from tests necessary to ensure conformance with specifications and standards including:

  • a description of the sample received for testing together with the material name, batch number or other distinctive code and date the sample was taken,

  • a statement referencing each test method used,

  • a record of raw data secured during each test including graphs, chromatograms, charts and spectra from laboratory instrumentation, identified to show the specific material and batch tested,

  • a record of calculations performed in connection with the test,

  • test results and how they compare with established specifications,

  • a record of the person who performed each test and the date(s) the tests were performed.

There should be a documented procedure for the preparation of laboratory reagents and solutions. Purchased reagents and solutions should be labelled with the proper name, concentration and expiry date. Records should be maintained for the preparation of solutions including the name of the solution, date of preparation and quantities of material used. Volumetric solutions should be standardised according to an internal method or by using a recognised standard. Records of the standardisation should be maintained.

Where used, primary reference reagents and standards should be appropriately stored and need not be tested upon receipt provided that a certificate of analysis from the supplier is available. Secondary reference standards should be appropriately prepared, identified, tested, approved and stored. There should be a documented procedure for the qualification of secondary reference standards against primary reference standards. The re-evaluation period should be defined for secondary reference standards and each batch should be periodically re- qualified in accordance with a documented protocol or procedure.

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

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