Infrastructure The organisation shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable:— (a) buildings, workspace and associated utilities, (b) process equipment (both hardware and software), and (c) supporting services (such as transport or communication). The manufacturer shall establish documented requirements for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality. Records of such maintenance shall be maintained. 6.4 Work environment: The organisation shall determine and manage the work environment needed to achieve conformity to product requirements. Following requirements shall apply, namely:— Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 142 of 248 (a) the manufacturer shall establish documented requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could adversely affect the quality of the product; (b) if work environment conditions can have an adverse effect on product quality, the manufacturer shall establish documented requirements as per Annexure-'A' of this Schedule for the work environment conditions and documented procedures or work instructions to monitor and control these w'ork environment condition; (c) the manufacturer shall ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are appropriately trained and supervised by a trained person; (d) if appropriate, special arrangements shall be established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel; (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.