Equipment Specifying, manufacturing operating

The P IDs will identify the major equipment components to be modified or procured for the new process. It will outline the new equipment and associated controls required to run the process. The API manufacturer may have preferred suppliers of this equipment because of operability or maintenance issues. Most of the vessel and component suppliers in the industry are capable of supplying cGMP compliant equipment. The design firm or the API manufacturer will specify the equipment to include the necessary appurtenances to make the equipment cleanable. 

Plant-operating personnel shall regularly check the conditions at which the equipments are actoally operated and the actoal load on various drive motors for the process units and machinery. The observed values shall be always compared with maximum limits permitted with design values/specified by manufacturer. 

Operation without outriggers. If the work area or the terrain precludes the use of outriggers, the equipment may be operated only within its maximum load ratings specified by the equipment manufacturer for the particular configuration of the equipment without outriggers. 

Other Types of Pallets. In addition to using forklift trucks or hand-operated equipment for major movements in the plant, there are other handling requirements for movement of materials within and between manufacturing operations. Generally there is very httle standardization in this area, since the carrier surfaces have to be specified to be compatible with equipment or product. 

These systems have been operated in extremely low quality (and radioactivity contaminated) industrial environments for the past several years without any major equipment or component failures. Utilizing specialized operating/warm-up procedures, they have operated in low grade, out-of-doors, dust ridden, rain-soaked, industrial environments at temperature ranges which greatly exceed the original equipment manufacturers (OEM) specified limits. The systems have been successfully operated at ambient temperatures of minus 10 to plus 103 degrees Fahrenheit without any pre-mature or un-anticipated equipment failures. 

Inspection. While work on the contract of the purchaser is being performed, the purchaser s inspector shall have reasonable access to the appropriate parts of the manufacturer s works concerning the manufacture of the equipment ordered hereunder. Inspection shall be made at the works prior to shipment, unless otherwise specified, and shall be conducted so as not to interfere unnecessarily with the works operation or production schedules. 

All instrumentation should be operated in accordance with operating instructions as supplied by the manufacturer, unless otherwise specified in the work plan. Equipment checkout and calibration activities should be done and documented prior to site characterization. 

All personnel involved in GMP production of drugs have to take ownership of quality. It is a requirement that processes and equipment for drug manufacturing must be approved and operated by trained, qualified personnel. Quality-related activities have to be recorded to enable traceability of data and information. Deviations and excursions of processes and results from specified conditions or criteria have to be reported, investigated, and resolved. Drug products have to be tested and must meet specifications before being... 

Scheduled prevenhve maintenance is performed to prevent breakdowns or mal-fiinchons, to prolong the hfe of an instrument, and to maintain ophmum operating characlerishcs. For automated immunostainers, the performance and documentahon of maintenance/funchon checks should be done as defined by the manufacturer with (at least) the frequency as specified. In general, common laboratory equipment such as pipets, centrifuges, and balances need to be serviced or cahbrated twice yearly. 

It is important to note that the small-scale agitator operations may be described in terms of impeller diameter and agitator speed, while manufacturing process equipment is more conveniently specified by horsepower and fluid velocity. For most standard turbine configurations, power number correlations are available to convert impeller diameter and agitator speed into a horsepower value for given fluid properties. Most laboratory bench equipment is designed to provide a torque measurement that can be readily converted to horsepower directly from the conditions of the pilot batches. 

The parameters selected should be appropriate for the process, in those cases where the manufacturing process has been controlled and validated as specified in the foregoing discussion, batch scale-up, changes in site of manufacture, allowance for equipment change (where the operating principle is the same), minor formulation changes, etc., should be determined on the basis of the comparability of both the blend/granulation and the final product as assured by (1) appropriate tests, (2) specifications, (3) process validation, and (4) comparative accelerated stability . 

Installation Qualification After equipment selection, it is necessary to assure that the equipment is installed well. The IQ document describes and validates the procedure of the equipment installation. It establishes confidence that the process equipment and ancillary systems are capable of consistently operating within established limits and tolerances [10]. The equipment manufacturer and pharmaceutical company must agree and check the IQ, which must be approved by the pharmaceutical company at the end. This document certifies that equipment was installed as specified by the manufacturer and the purchaser. 

Installation qualification is an exercise that shows the equipment has been installed properly, as specified either by the equipment manufacturer or by the purchaser. Operation qualification demonstrates that the equipment operates as intended. The operation of the equipment is compared to the equipment manufacturer s specification or the excipient manufacturer s design specification. Finally, the performance qualification shows that the equipment performs as intended. Where production equipment is involved, performance qualification usually involves running a trial substance such as water or a production batch. 

In the case of a computer system applied to a live manufacturing process and integral with plant equipment and the process itself, the project validation plan should specify the relationship of the computer system qualification activities and documentation with that of the corresponding plant equipment qualification and process validation. Indeed, the qualification activities and documentation of these elements of a computerized operation are sometimes combined. 

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