Quality Management System for Active pharmaceutical

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Quality Management System - integrating GMP into ISOC. GlossaryPrincipleThis glossary covers the meaning of the words used in this guide.Active Pharmaceutical Ingredient (API)Any pharmaceutically active material from organic, inorganic, microbiological, animal or plantorigin, including that produced by recombinant DNA methods, intended for use in themanufacture of a medicinal product for human and or veterinary use.AuditSystematic and independent examination to determine whether quality activities and relatedresults comply with quality policy and if this policy has been implemented effectively.Batch (or lot)A defined quantity of a material produced in a process or series of processes so that it isexpected to be homogeneous within specified limits. In the case of continuous production thebatch (or lot) may be defined by a fixed quantity or time.Batch number (or lot number)A distinctive combination of numbers and/or letters which specifically identifies a batch or lotand from which the production history can be determined.CalibrationComparison of measuring instrument performance against an approved standard leading, ifappropriate, to correction of performance of the instrument.ChangeAny deliberately introduced modification to existing documents, processes, equipment, systemsor testing methods.5
Quality Management System - integrating GMP into ISOChange controlFormal system to evaluate effects of any change.Computer systemA system including the input of data, electronic processing and the output of information to beused either for reporting or automatic control.Computerised systemA system including computer system, all sensors, transmitters, actuators and wiring needed tocontrol the process.Conditional statusStatus given to a material waiting to be fully tested and formally released.ConformityFulfilment of specified requirements.ContaminationThe unintended, non-process related, introduction of impurities of a chemical ormicrobiological nature, or of foreign matter, into or onto a material during production,sampling, packaging or repackaging, storage or transport.Continuous productionA process in which a material is continuously produced in a step or series of steps. In acontinuous process the batches of raw materials and the process parameters can be statistically,but not necessarily, correlated to the material produced in a given window of time.Contract reviewSystematic activities carried out by the supplier before signing the contract to ensure thatrequirements are adequately defined, free from ambiguity, documented and achievable.6
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Quality Management System for Active pharmaceutical

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