Quality Management System for Active pharmaceutical

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Quality Management System - integrating GMP into ISO15.2.2 Receipt into and despatch from storage should be authorised and recorded and theprinciple of FIFO (first in, first out) or FEFO (first expired, first out) isrecommended.15.2.3 The condition of stored material should be assessed at appropriate intervals.15.2.4 Storage conditions for API should be based upon stability studies taking intoaccount time, temperature, humidity, light etc.15.2.5 Materials requiring special storage conditions (temperature, humidity, light etc.)should be clearly labelled and held in a suitable environment.15.2.6 Storage procedures should ensure physical (or an effective alternative) segregationof materials to avoid mix-ups occurring. Materials which have been rejected, recalledor returned should be physically segregated from other stock until their finaldisposition has been determined unless adequate control can be ensured by validatedelectronic systems.15.3 Packaging15.3.1 Labelling and packaging processes should be defined and controlled to ensure thatcorrect packaging materials are used correctly and other specified requirements aremet.15.3.2 Printed labels should be securely stored to avoid mix-ups arising.15.3.3 Marking and labelling should be legible and durable, provide sufficient informationfor accurate identification and indicate, if appropriate, required storage conditions,retest and/or expiry date.15.4 PreservationPrecautions should be taken to maintain the quality of materials and APIs.15.5 Delivery15.5.1 If necessary the supplier should ensure that released material is transported underadequately controlled conditions such that quality is maintained upon delivery to thecustomer.45
Quality Management System - integrating GMP into ISOControls should include, but may not be limited to, the following:- Vehicles should be checked to ensure that they are clean and dry with noevidence of chemical contamination or infestation, and offer adequate protectionfrom the weather.- Materials should be clearly and securely identified, adequately segregated fromother materials, protected from breakage and theft and subject to appropriateenvironmental controls.15.5.2 Records of distribution should be maintained so that, if necessary, users can bereadily contacted.46
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Quality Management System for Active pharmaceutical

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