E. BUILDINGS AND
FACILITIES
(a) FACILITY MAPS
Provide the following
maps:
1. Aerial view of the facility
including surrounding roads, open air storage, all buildings and parking lots;
and
2. A layout of each area of each
floor used for production, storage and/or labeling of drug products and
intermediates. This layout should indicate rooms and their use, reactors, tanks,
dryers, columns, centrifuges, filters and any other fixed piece of production
equipment.
(b) DESIGN AND CONSTRUCTION
FEATURES
Describe how and when each
buildings was constructed. Give details on design and construction features
including the following:
a. Building materials of walls, floors and ceilings, platforms, mezzanines,
etc.;
b. Electrical power and source, and type of lighting in different
areas;
c. Air ventilation exhaust/intake, special purpose air filtration systems,
heating/air conditioning, etc.;
d. Water supply. We highlight this subject because FDA has made it clear
that there are strict limits on water used in the production of bulk
pharmaceuticals;
1. Water used in the production of bulk pharmaceuticals must be at
least potable grade in initial steps of
production.
2. Water used in final steps, including washings, should be
deionized.
Include a description of the different kinds of water used, e.g.,
deionized, ultra-filtered, potable, etc. . Cite the SOPs for the control of the
different systems. Betterchem can refer you to experts on this subject.
e. Sewer system and drainage. Make certain that the system complies with 21
CFR 211.48.
f. Washing and toilet facilities.
(c) MAINTENANCE
Describe protocol for the routine and periodic maintenance the items
described in (b). Include the following:
1. Who (title) is responsible for cleaning and maintenance for each area of
the facility, e.g., who cleans the warehouse, the wash rooms, the production
areas, the common areas, etc;
2. Pest control protocol and documentation. The responsibility for pest
control belongs to Quality Control. Give reference to a SOP and describe where
the "Pest Control Logbook" can be found;
3. GMP self-inspection program and documentation. Describe who (title)
is in charge and the location where the records may be found;
4. Documentation protocol for repair work done internally or by outside
contractors. Describe who (title) is in charge and the location where the
records may be found;
5. Is there a uniform program for the workers? Describe this and give
reference to a SOP; and
6. Describe the protocol for safety equipment use.
Type 2 DMF Guide
