Section 108.5 - Preparation of legendsA brief description of the activities performed in each room or area shall be prepared as provided in this section and shall be referred to as a legend. Legends shall be provided for each plot plan and each blueprint or drawing. All pages of the legends shall be numbered, identified with corresponding plot plan or blueprint, and submitted in booklet form either stapled together or clipped into a suitable folder.
(a) Plot plan legends shall show the following:(1) Number of each building and the functions performed in each: Provided, That if it is a multiple-story building in which biological products are prepared or handled, briefly describe functions performed on each floor.(2) A practical and nontechnical description of construction materials used throughout those buildings used entirely or partially for production and handling of biological products.(b) Blueprint legends shall show the following:(1) A listing of all rooms by identifying letters or numbers and the fractions prepared in each. Exceptions may be listed for general purpose areas or rooms. Functions performed in each area and room shall be described, whether the licensed or unlicensed products. In rooms where products are exposed to the surroundings, a description of decontamination procedures and other precautions against cross contamination shall be included.(2) A listing of the coded stationary equipment.(3) A general listing of other essential biological equipment such as mills, centrifuges, mixing tanks, bottling and sealing equipment, and the like, which are not regarded as stationary but are maintained in certain rooms.39 FR 16854, May 10, 1974, as amended at 40 FR 51413, Nov. 5, 1975; 50 FR 50764, Dec. 12, 1985