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APPENDIX B

DEFINITIONS AND GLOSSARY

As used throughout this Guide, the terms below have the following meaning. Wherever possible definitions used by the International Conference on Harmonisation have been used as the basis for this glossary.

Acceptance criteria Numerical limits, ranges or other suitable measures of acceptance for test results.

Active Pharmaceutical Ingredient (API) Any substance or mixture of substances, intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or any function of the body of man or animals.

Adulterated Material A material that has been contaminated with either a foreign material or not manufactured using GMP. This does not pertain to a material that simply does not meet physical or chemical specifications.

Batch (Lot) A specific quantity of material produced in a process or series of processes so that it can be expected to be homogeneous. In the case of continuous processes, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.

Batch Number (Lot Number) A unique combination of numbers, letters and/or symbols that identifies a batch and from which the production and distribution history can be determined.

Batch Process A process that produces the excipient from a discrete supply of raw materials that are present before the completion of the reaction.

Batch Record Documentation that provides a history of the manufacture of a batch of excipient.

Calibration The demonstration that a particular instrument or measuring device produces results within specified limits by comparison with those produced by a reference or traceable standard, over an appropriate range of measurements.

CEP (Certificate of Suitability to the European Pharmacopoeia) Certification granted to individual manufacturers by the European Directorate for the Quality of Medicines (EDQM) when a specific excipient or active ingredient is judged to be in conformity with a Ph. Eur. monograph.

Certificate of Analysis A document listing the test methods, specification and results of testing a representative sample from the batch to be delivered.

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

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