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Saturday, March 10, 2018

FDA Guide to Equipment design, size, and location 211.63

FDA Guide to Equipment design, size, and location 211.63
Subpart D--Equipment

Sec. 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.

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.



Good Manufacturing Practices for Pharmaceuticals, Sixth Edition edited by Joseph D. Nally GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.


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