GMP Equipment Design, Size, and Location

By: Pharma Tips | Views: 6628 | Date: 24-Apr-2011

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.

GMP 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.

The effectiveness of equipment, like the quality of a product, starts at the design stage. Most pharmaceutical companies are not directly involved with the designs and construction of equipment but hey can contribute indirectly. They can, and don, provide information on requirements and feedback on existing equipment.

GMP Equipment Design, Size, and Location


 When evaluating alternate types of makes of equipment, several parameters need to be considered:

1.    Operating criteria are adequate for the process-size, speed, effectiveness (of, say, a mixer).
2.    Availability of spares and servicing. This can result in using different makes of equipment in different parts of the world.
3.    Maintenance. 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 needing to be cleaned and the relative ease of disassembly and reassembly.
4.    Environmental issues. Does the equipment disseminate dust, with the potential for contaminating other products or making it necessary
      for operators to wear additional protective clothing and facilities to be cleaned more frequently? The possible impact of noise and energy
      use and dissipation should be considered.
5.    Construction materials, and design.
6.    Availability of process controls such as automatic weight adjustment on tablet presses and temperature recorders on ovens.  Although
       initially more expensive they could prove to be very economic overall by providing more consistent product quality and better records.
7.    Cost. A comprehensive cost should, if possible, be compiled which will include the base price plus any additional costs associated with
       points 2-4 above.
8.    Availability of design and maintenance manuals from the supplier that are important for validation/qualification and maintenance
       programs.

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 operations, 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.

    This requirement affects the design, construction, and placement of manufacturing equipment. Motors, drive belts, gears, and other potential sources of lubricant contamination should be located away from vessel or package openings that could result in product contamination. For equipment where this is not possible, such as some mixers and tablet and encapsulating machines, lubrication needs to be controlled and monitored; buildup of lubricant and powdered product should be regularly removed and lubricants should be of food grade.

    Gaskets and other connecting surfaces should be monitored to ensure they don't break down, thereby allowing environmental contamination or gasket particles into the product.


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 .

    The importance of cleaning was further emphasized by the publication of FDA "Guide to Inspections of Validation of Cleaning Procedures" in July 1993. This guide suggests that FDA investigators evaluate key areas including:

1.    Availability of approved validation protocols.
2.    Approved validation reports.
3.    Equipment design and cleanability.
4.    Defined, reproducible cleaning procedures that address difficult to clean areas. Different cleaning procedures are acceptable products.
       For manual cleaning operations, it is essential that sufficient detail is provided to give a high level of assurance that the procedure will be
       performed essentially the same way by different operators. For example, "wash with water" would be totally unacceptable. Repeat
      cleaning until test results are acceptable is considered indicative of a nonvalidated process.
5.    Time scales between use and cleaning and between cleaning and reuse.
6.    Operator training.
7.    Specificity and sensitivity of analytical methods – which must be validated, along with recovery levels. Although specific analytical
       methods are most frequently used, another alternative is a general method such as total organic carbon, which will evaluate all carbon-
       containing materials.
8.    Sampling methods.

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 date 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.

FILTERS
Filters for liquid filtration used in the manufacture, processing, or packing of injectable of 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 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 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.

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