Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 15: Handling, storage, packaging, preservation anddeliveryPrincipleLoss, damage or deterioration should be prevented during the handling, storage, packaging andpreservation of material from receipt through manufacture, final release to despatch and, ifappropriate, delivery to the customer. The application of relevant procedures should beadequately controlled and monitored.15.1 Handling15.1.1 Plant and handling procedures, including equipment maintenance and cleaning,should be properly identified, planned and designed for use by trained staff.15.1.2 Incoming materials should not be mixed with existing stocks (e.g. solvents or stocksin silos) until they have been inspected and/or tested and released.15.1.3 Sampling of API should be performed in an appropriate area and using proceduresdesigned to prevent contamination. Containers should be opened carefully andsubsequently resealed in an approved manner.15.1.4 Weighing or subdivision of material prior to use should be performed in anappropriate area to minimise the risk of cross-contamination.15.1.5 Pure and final API should be handled in an environment giving adequate protectionagainst contamination.15.1.6 Highly sensitising material such as penicillins and cephalosporins should be handledin separate production areas.15.1.7 Highly active or toxic API (e.g. certain steroids, cytostatic substances) should bemanufactured in a dedicated area and using dedicated equipment.15.2 Storage15.2.1 Secure storage facilities should be designated for use to prevent damage ordeterioration of materials. These should be kept clean and tidy and subject toappropriate pest control measures. Environmental conditions should be recorded.44