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identifiable with the product involved. Pertinent subcontractor quality data should be an element of these records.

Entries in records should be clear, indelible, made directly after performing the activity (in the order performed), signed and dated by the person making the entry. Corrections to entries should be signed and dated, leaving the original entry legible.

Records should be kept for a defined period. This period should be appropriate to the excipient, its expiry date or re-evaluation interval. Records should be stored and maintained in such a manner that they are readily retrievable, in facilities that provide a suitable environment to minimise deterioration or damage.

4.3 Change Control

The excipient manufacturer should establish and maintain procedures to evaluate and approve changes that may have an impact on the quality of the excipient. For example this may include changes to:

  • raw materials or packaging and their sources,

  • material specifications,

  • test methods,

  • manufacturing and analytical equipment,

  • production processes,

  • manufacturing or packaging sites etc.

A function that is independent from production (such as regulatory affairs, quality assurance, etc.) should have the responsibility and authority for the final approval of changes.

Customers and, if necessary, regulatory authorities (for example for Drug Master Files (DMFs) or Certificates of Suitability to the European Pharmacopoeia (CEPs)) should be notified of significant changes from established production and process control procedures that may affect excipient quality (see also 7.2.3 and Appendix C). The IPEC-Americas Significant Change Guide for Bulk Pharmaceutical Excipients provides criteria that the excipient manufacturer can use to determine when to involve the pharmaceutical customer, based on the likelihood that a proposed change will impact their drug product.


Top management should demonstrate to the organisation the importance it places on customer satisfaction and compliance with the appropriate regulations and standards. This should be accomplished through the development of a quality policy and establishment of quality objectives. Progress towards the documented quality objectives should be reviewed at planned intervals.

5.2 Customer Focus

It is the responsibility of top management to ensure that customer requirements are determined and met.

The excipient manufacturer should permit the customer or their representative to conduct audits to review its quality management system, manufacturing processes, buildings and facilities.

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

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