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8.2.4.2 Finished Excipient Testing and Release Finished excipient testing should be performed on each batch to ensure that the excipient conforms to documented specifications. There should be a procedure to ensure that appropriate manufacturing documentation, in addition to the test results, is evaluated prior to release of the finished excipient. The quality unit should be responsible for the release of the finished excipient.

For excipients produced by continuous processes assurance that the excipient conforms to documented specifications may be achieved through the results of in-process testing or other process control records.

8.2.4.3 Out-of-Specification Test Results Out-of-specification (OOS) test results should be investigated and documented according to a documented procedure.

Retest sample results may only be used to replace the original test result if it is demonstrated that the original result is erroneous based on a documented investigation.

When statistical analysis is used both the original and retest data must be included. The OOS procedure should define which statistical techniques are to be used and under what circumstances.

These same principles apply when the sample is suspected of not being representative of the material from which it was taken.

8.2.4.4 Retained Samples Where practical, a representative sample of each batch of the excipient should be retained. The retention period should be appropriate to the expiry or re- evaluation date. The retained samples should be stored and maintained in such a manner that they are readily retrievable in facilities that provide a suitable environment. The sample size should be at least twice the amount required to perform complete specification testing.

8.2.4.5 Certificates of Analysis The organisation should provide certificates of analysis to the required specification for each batch of excipient. More details on the suitable contents of a certificate of analysis can be found in the IPEC-Americas Certificate of Analysis Guide for Bulk Pharmaceutical Excipients and the UK Guidance on Certificates of Analysis from The Rules and Guidance for Pharmaceutical Manufacturers and Distributors.

8.2.4.6 Impurities Where possible, excipient manufacturers should identify and set appropriate limits for impurities. The limits should be based upon appropriate safety data, limits as described in official compendia or other requirements and sound GMP considerations. Manufacturing processes should be adequately controlled so that the impurities do not exceed such established limits.

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

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