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Commissioning The introduction of equipment for use in a controlled manner.

Contamination The undesired introduction of impurities of a chemical or microbiological nature or foreign matter into or onto a raw material, intermediate or excipient during production, sampling, packaging or repackaging, storage or transport.

Continuous Process A process that continually produces material from a continuing supply of raw material.

Critical A process step, process condition, test requirement or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the excipient meets its specification.

Cross-Contamination Contamination of a material or product with another material or product.

Customer The organisation receiving the excipient once it has left the control of the excipient manufacturer; includes brokers, agents and users.

Deviation Departure from an approved instruction or established standard.

Drug Master File (DMF) Detailed information about the manufacture of an excipient that is submitted to the United States Food and Drug Administration.

Drug (Medicinal) Product The dosage form in the final immediate packaging intended for marketing.

Excipient Substances other than the API which have been appropriately evaluated for safety and are intentionally included in a drug delivery system.

Expiry (Expiration) Date The date designating the time during which the excipient is expected to remain within specifications and after which it should not be used.

Impurity A component of an excipient that is not intended to be present but arises as a consequence of the manufacturing process.

In-process Control/Testing Checks performed during production to monitor and, if appropriate, to adjust the process and/or to ensure that the intermediate or excipient conforms to its specification.

Intermediate Material that must undergo further manufacturing steps before it becomes an excipient.

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

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