21
Code of Federal Regulations
Parts
211
Subpart
D-Equipment
§
211.63 Equipment design, size, and location.
Equipment
used in the manufacture, processing, packing, or holding of a drug product
shall be of
appropriate
design, adequate size, and suitably located to facilitate operations for its
intended use and for its cleaning and maintenance.
§
211.65 Equipment construction.
(a)
Equipment shall be constructed so that surfaces that contact components,
in-process materials, or drug products shall not be reactive, additive, or
absorptive so as to alter the safety, identity, strength, quality, or purity of
the drug product beyond the official or other established requirements.
(b)
Any substances required for operation, such as lubricants or coolants, shall
not come into contact with components, drug product containers, closures,
in-process materials, or drug products so as to alter the safety, identity,
strength, quality, or purity of the drug product beyond the official or other
established requirements.
§
211.67 Equipment cleaning and maintenance.
(a)
Equipment and utensils shall be cleaned, maintained, and sanitized at
appropriate intervals to
prevent
malfunctions or contamination that would alter the safety, identity, strength,
quality, or purity of the drug product beyond the official or other established
requirements.
(b)
Written procedures shall be established and followed for cleaning and
maintenance of equipment, including utensils, used in the manufacture, processing,
packing, or holding of a drug product. These procedures shall include, but are
not necessarily limited to, the following:
(1)
Assignment of responsibility for cleaning and maintaining equipment;
(2)
Maintenance and cleaning schedules, including, where appropriate, sanitizing
schedules;
(3)
A description in sufficient detail of the methods, equipment, and materials
used in cleaning and maintenance operations, and the methods of disassembling
and reassembling equipment as necessary to assure proper cleaning and
maintenance;
(4)
Removal or obliteration of previous batch identification;
(5) Protection of clean equipment
from contamination prior to use;
(6) Inspection of equipment for cleanliness immediately before
use.
(c) Records shall be kept of maintenance, cleaning, sanitizing,
and inspection as specified in §§
§
211.68 Automatic, mechanical, and electronic equipment.
(a)
Automatic, mechanical, or electronic equipment or other types of equipment,
including computers, or related systems that will perform a function
satisfactorily, may be used in the manufacture, processing, packing, and
holding of a drug product. If such equipment is so used, it shall be routinely
calibrated, inspected, or checked according to a written program designed to
assure proper performance. Written records of those calibration checks and
inspections shall be maintained.
(b)
Appropriate controls shall be exercised over computer or related systems to
assure that changes in master production and control records or other records
are instituted only by authorized personnel. Input to and output from the
computer or related system of formulas or other records or data shall be
checked for accuracy. The degree and frequency of input/output verification shall
be based on the complexity and reliability of the computer or related system. A
backup file of data entered into the computer or related system shall be
maintained except where certain data, such as calculations performed in
connection with laboratory analysis, are eliminated by computerization or other
automated processes. In such instances a written record of the program shall be
maintained along with appropriate validation data. Hard copy or alternative
systems, such as duplicates, tapes, or microfilm, designed to assure that
backup data are exact and complete and that it is secure from alteration,
inadvertent erasures, or loss shall be maintained.
[43
FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]
§
211.72 Filters.
Filters
for liquid filtration used in the manufacture, processing, or packing of
injectable drug products intended for human use shall not release fibers into
such products. Fiber-releasing filters may not be used in the manufacture,
processing, or packing of these injectable drug products unless it is not
possible to manufacture such drug products without the use of such filters. If
use of a fiber-releasing filter is necessary, an additional non-fiber-releasing
filter of 0.22 micron maximum mean porosity (0.45 micron if the manufacturing
conditions so dictate) shall subsequently be used to reduce the content of
particles in the injectable drug product. Use of an asbestos-containing filter,
with or without subsequent use of a specific non-fiber-releasing filter, is
permissible only upon submission of proof to the appropriate bureau of the Food
and Drug Administration that use of a non-fiber-releasing filter will, or is
likely to, compromise the safety or effectiveness of the injectable drug
product.
Comments
Post a Comment