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Record Document stating results achieved and/or providing evidence of activities performed. The medium may be paper, magnetic, electronic or optical, photographic etc. or a combination thereof.

Re-evaluation Date (Retest Date) The date when the material should be re-examined to ensure that it is still in conformance with the specification.

Reprocessing Repetition of an activity that is a normal part of the manufacturing process and that has been documented previously.

Retrieval Process for the removal of an excipient from the distribution chain.

Reworking Subjecting previously processed material that did not conform to standards or specifications to processing steps that differ from the normal process.

Specification A list of tests, references to analytical procedures and appropriate acceptance criteria that are numerical limits, ranges or other criteria for the tests described for a material.

Stability Continued conformance of the excipient to its specifications.

Top Management Person or group of people who direct and control an organisation at the highest level. The highest level can either be at the site or corporate level and will depend on the way that the quality management system is organised.

Traceability Ability to determine the history, application or location that is under consideration, for example origin of materials and parts, processing history or distribution of the product after delivery.

Validation A documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting predetermined acceptance criteria.

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

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