(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;