Quality Management System for Active pharmaceutical

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Quality Management System - integrating GMP into ISOChapter 8: Product and equipment identification and traceabilityPrincipleIt should be possible to identify and trace any material from receipt through production anddelivery to the customer. All quality critical equipment should also be identified and its use betraceable.8.1 Materials and equipment identification8.1.1 Raw materials, auxiliaries, packaging materials, intermediates and API should beassigned a unique code which allows the traceability of materials. Whereappropriate, this code should be included on the label of each container upon receiptor isolation.8.1.2 Each item of equipment influencing product quality should be clearly identified.8.2 Batch (or lot) identificationAny batch (or lot), received or produced should be assigned a unique code to allowfor the traceability of all materials and equipment used in its manufacture.8.3 Labelling8.3.1 There should be a written procedure describing the system for labelling materials andequipment.8.3.2 Each container should be identified by an appropriate label, showing at least theproduct identification and the assigned batch code, or any other easilyunderstandable combination of both. Other data, such as weight, storage conditions,safety or transport instructions can also be included on the label.8.3.3 Control should be exercised over labels used during the manufacture and filling ofAPI, including label reconciliation, to absolutely minimise the risk of label mix-upsor the use of incorrect or out-of-date labels.8.3.4 Containers for external distribution may require additional labels. These should beadequately controlled and contain relevant information to meet user requirements aswell as compliance with applicable safety and transport regulations. If the APIrequires special transport or storage conditions, this should be stated on the labeland complied with.27
Quality Management System - integrating GMP into ISO8.3.5 If containers are reused a check should be performed to ensure that the previouslabels have been removed or adequately defaced.8.3.6 Quality critical equipment should be clearly and uniquely identified, together with anindication of status (e.g. clean; awaiting cleaning; in use; out of order). When in usethe content of each item of equipment should be identifiable.8.3.7 Material, product, equipment and status information should be recorded to facilitatesubsequent traceability.28
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Quality Management System for Active pharmaceutical

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