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    • labelling control records,

    • description of excipient product containers and closures,

    • description of sampling performed,

    • failures, deviation and their investigations,

    • results of final product inspection.


          Equipment Cleaning

The manufacturer should design and justify cleaning and sanitisation procedures and provide evidence of their effectiveness. In multi-purpose plants the use of the “model product approach” (groups of product of similar type) may be used in justifying a suitable procedure.

Cleaning and sanitisation procedures should be documented. They should contain sufficient detail to allow operators to clean each type of equipment in a reproducible and effective manner. There should be a record confirming that these procedures have been followed.

Equipment and utensils should be cleaned and sanitised where critical to excipient quality and at appropriate intervals to prevent contamination and cross- contamination of the excipient. The cleaning status of equipment should be recorded appropriately.

Where multi-purpose equipment is in use it is important to be able to determine previous usage when investigating cross-contamination or the possibility of such contamination (see also

During a production campaign incidental carry-over frequently occurs and is acceptable usually since clean-up between successive batches of the same excipient is not normally required to maintain quality levels. Products that leave residues that cannot be effectively removed should be produced in dedicated equipment.

For continuous processing the frequency of equipment cleaning should be determined by the manufacturer and justified. Recovery of Solvents, Mother Liquors and Second Crop Crystallisations Where solvents are recovered and reused in the same process or different processes they should meet appropriate standards prior to reuse or mixing with other approved material.

Mother liquors or filtrates containing recoverable amounts of excipient, reactants or intermediates are frequently reused. Such processes should be documented in the production records or logs to enable traceability. In-process Blending or Mixing In process blending or mixing to assure batch uniformity or to facilitate processing should be controlled and documented. If the intent of the operation is to ensure batch uniformity it should be performed so as to assure homogenous mixing of materials to the extent feasible and should be reproducible from batch to batch.

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

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