FDA Guide to Equipment design, size, and location 211.63
Subpart D--Equipment
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.
In order to properly
specify equipment and systems, the pharmaceutical manufacturer needs to
identify the manufacturing process. This requires that during the development
of the product, the critical quality attributes (CQA) of the product, and the
associated critical process parameters (CPP) that directly affect the
attributes, be identified and the effort of the parameters on the attributes be
understood. These requirements are to be included in a user requirements
specification (URS) of the equipment/system. This specification is to focus
only on the manufacturing requirements, for example, range of critical
processing parameters, sensitivity of the control system to maintain these
parameters, and so on. The purpose of this focus is to ensure that the
qualification testing is limited only to the equipment capabilities that are
required to manufacture an effective product.
In the past it was
common to have qualification testing address all equipment’s/system
capabilities. However, this type of testing is normally addressed during the
start-up and commissioning of the equipment/system. Only capabilities that the
manufacturing characteristics are tested during qualification. Therefore,
commissioning tests the equipment/system against the requirements of the
purchased specification, whereas the qualification testing address those
requirements in the URS.
An important tool
used during the selection of equipment is to perform an impact assessment. The impact
assessment provides a scientific rationale to the effect the equipment system
has on the quality attributes of the product being manufactured. The assessment
segregates equipment system into three categories: direct impact, indirect impact,
and no impact. This categorization enables the appropriate attention to be
directed towards the specification, installation, and qualification of equipment
system.
Once the use of equipment
system has been properly identified, as indicated in the previous edition,
several parameters are to be considered when evaluating the equipment:
1.
Availability of
spares and servicing
2.
The frequency and
ease of maintenance will significantly impact on productivity and even quality.
Equipment breakdown during processing could adversely affect quality. Included
in the maintenance evaluation should be the cleanability of the equipment. This
will involve accessibility to the
parts to be cleaned and the relative ease of disassembly.
3.
Environmental issues are important constructions. Is the design of
the equipment conducive to the application? Such attributes as the ability to
contain toxic products, the ability to contain dust, the ability to maintain
aseptic conditions, etc. need to be reviewed.
4.
Construction materials and design (see 211.65)
5.
The type of process controls such as automatic weight adjustment on
tablet presses and temperature recorders on ovens. The use of these controls
has become a routine and is expected in today’s manufacturing environment. The PAT
initiative depends upon these controls to demonstrate that the manufacturing
process is under control and to facilitate a continuous improvement program.
New equipment should
not be used for commercial production until it has been qualified and the proceeds
in which it is to be used has been validated; this applies equally to laboratory
and other test equipment. All equipment should be appropriately identified with
a unique number, to allow reference in maintenance programs and in batch
records (see also 211.105(a)).
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The location of the equipment
in the facility must enable an efficient flow of the manufacturing process. Manufacturing
trains should be uni-directional whenever feasible. Back flow or cross flow within the process are to be minimised, as these incidences inherently have a
high capability to cause mistakes.
The equipment system
is to be placed in such a manner so as to enable all parts requiring maintenance,
instrumentation, and calibration to be easily accessible. The key is easily
accessible. Locating equipment in areas that are inaccessible usually means the
maintenance and cleaning operational are not performed adequately, and thus leads
to errors during the manufacturing of products.
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