Quality Management System for Active pharmaceutical

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Quality Management System - integrating GMP into ISO- special care should be taken to avoid contamination of other equipment, otherproducts, or the environment- if local dust extraction alone is used, a subsequent clean up should be performedto minimise contamination or cross contamination9.2.4 Where highly toxic or highly active API are being processed, isolation, drying andblending should be performed in a closed system or a separate dedicated area.9.2.5 Filling and packaging operations should be performed in facilities which preventcross contamination either of the material being handled or of other materials by thatmaterial.9.3 Specific requirements9.3.1 The process should be controlled in compliance with quality plans, manufacturinginstructions and Good Manufacturing Practice principles.9.3.2 Suitable monitoring and control parameters should be chosen to ensure that theprocess is performing as intended by the process design.9.3.3 Monitoring of appropriate in-process controls and parameters will be required togive the necessary level of confidence in the quality of the finished product.9.3.4 If materials are recovered for re-use in future manufacturing processes, there shouldbe written evidence that the use of these materials will result in a product that meetsspecification.9.3.5 Solvents may be recovered and should be monitored for suitability of use.9.3.6 If the working up of mother liquors or similar materials to obtain further materials oran API is performed, the action should be specifically described in writing andrecorded.9.3.7 The practice of blending out-of-specification API with material that meetsspecification, in order to disguise the defects and create a composite that meetsspecification, is not acceptable.31
Quality Management System - integrating GMP into ISO9.4 Criteria of workmanshipThere should be documentation available that describes in clear detail the standard ofworkmanship required. For training purposes, the use of diagrams, illustrations,reference standards and / or pictures showing the expected results are recommended.9.5 MaintenanceThere should be a maintenance policy established to ensure that equipment ismaintained to a standard sufficient to ensure that it is capable of performing itsintended function (see Annex B).32
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Quality Management System for Active pharmaceutical

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