Equipment identification

Each piece of equipment shown on the flow-sheet must be identified with a code number and name. The identification number (usually a letter and some digits) will normally be that assigned to a particular piece of equipment as part of the general project control procedures, and will be used to identify it in all the project documents. 

If the flow-sheet is not part of the documentation for a project, then a simple, but consistent, identification code should be devised. The easiest code is to use an initial letter to identify the type of equipment, followed by digits to identify the particular piece. For example, H—heat exchangers, C—columns, R—reactors. The key to the code should be shown on the flow-sheet. 

Laboratory equipment is sometimes stolen. Most popular are smaller items of relatively high value, such as electronic balances. Permanent identification marks definitely discourage theft. One stolen microscope was quickly returned to its owner when it appeared on the used equipment market. It was easily identifiable because its owner had engraved marks not only on the body, but also on objectives and eye pieces. The thief, fortunately, had ignored them. 

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The P and I diagram will resemble the process flow-sheet, but the process information is not shown. The same equipment identification numbers should be used on both diagrams. 

Labelling and Calibration Check calibration certificate, indicate equipment identification details ... 

Process vessels and equipment should be provided with identification in the field that is legible from approximately 30 meters (100 ft.) away. It should be viewable from the normal access points to the facility or equipment and is of colors contrasting with the surrounding background. The identifications normally consist of the equipment identification number and the common name of the equipment, e g., "V-200, Propane Surge Drum". This is beneficial during routine and emergency periods where the quick identification of process equipment is critical and necessary from a distance. 

Written procedures deviations Charge-in of components Calculation of yield Equipment identification... 

Production and Process Controls Critical Manufacturing Steps, Equipment Identification, In-Line and Bulk Testing, Actual Yield, Personnel Habits... 

Several method performance indicators are tracked, monitored, and recorded, including the date of analysis, identification of equipment, identification of the analyst, number and type of samples analyzed, the system precision, the critical resolution or tailing factor, the recovery at the reporting threshold level, the recovery of a second reference weighing, the recovery for the control references (repeated reference injections for evaluation of system drift), the separation quality, blank issues, out of spec issues, carry over issues, and other nonconformances. The quantitative indicators are additionally visualized by plotting on control charts (Figure 23). 

Include specific equipment identification, because omission can cause problems for readers in other process units or facilities who may have the same equipment and remain imaware of its hazards. Avoid downplaying human performance factors when drafting the report. There is a natural hesitancy to criticize or address normally encountered performance limitations or errors. Effects of fatigue from working excessive overtime are not always addressed in the written report. If these human performance factors are neglected, the error may be repeated. All facts of the incident must be considered relevant. 

Calibration records The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shah be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment. 

EQUIPMENT IDENTIFICATION Mixer manufactured by (vendor), with an approximate volume of 20 Gallons Coater/Dryer/Laminator manufactured by (vendor), Slitter/Rewinder manufactured by (vendor) and, Pouching Machine (with Die Cutter) manufactured by (vendor). Equipment numbers are identified in the appropriate section of this document. 

Testing/calibration equipment identification (e.g., traceable to national standards)... 

Written procedures are required to be established and followed for production and process controls as specified in 21 CFR Part 211.100. Because the specific requirements regarding handling of changes, deviations, and equipment identification are addressed in other sections of this article, and all other provisions of Subpart F are required in order to meet CGMP requirements for clinical supplies, this section will focus on the other aspects of Subpart F that provide unique challenges during clinical supply manufacture. 

This section focuses again on the need for written procedures and formal authorization by the quality control unit for any deviation from written procedures. Areas covered are addition of components calculation of yield equipment identification sampling and testing of in-process materials and drug products time limitations on production control ofmicrobiological contamination and reprocessing. 

Perform Installation Qualification. Verify equipment identification, required documents, utilities, manual, and drawings. 

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