(e) all personnel shall bear clean body covering appropriate to their duties. Smoking, eating, drinking, chewing or keeping food and drink shall not be permitted in production, laboratory and storage areas. 7.0 Product realisation 7.1 Planning of product realization The manufacturer shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system. In planning product realisation, the manufacturer shall determine the following, as appropriate:— (a) quality objectives and requirements for the product; (b) the need to establish processes, documents, and provide resources specific to the product; (c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;