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Lot See Batch.

Manufacture/Manufacturing Process All operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release and storage of excipients and related controls.

Master Production Instruction (Master Production and Control Record) Documentation that describes the manufacture of the excipient from raw material to completion.

Material A general term used to denote raw materials (starting materials, reagents and solvents), process aids, intermediates, excipients, packaging and labelling materials.

Model Product A product that represents a group of similar products with respect to composition, functionality or specification.

Mother Liquor The residual liquid that remains after crystallisation or isolation processes.

Packaging Material A material intended to protect an intermediate or excipient during storage and transport.

Production Operations involved in the preparation of an excipient from receipt of materials through processing and packaging of the excipient.

Quality Assurance The sum total of the organised arrangements made with the object of ensuring all excipients are of the quality required for their intended use and that quality systems are maintained.

Quality Control Checking or testing that specifications are met.

Quality-critical Describes a material, process step or process condition, test requirement or any other relevant parameter that directly influences the quality attributes of the excipient and which must be controlled within predetermined criteria.

Quarantine The status of materials isolated physically or by other effective means pending, a decision on their subsequent approval or rejection.

Raw Material A general term used to denote starting materials, reagents and solvents intended for use in the production of intermediates or excipients.

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

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