Management of measuring instruments in the production and inspection of pharmaceuticals include the following:
1. Measuring instruments selection and acquisition management
In accordance with the production and inspection of pharmaceuticals required, accuracy, resolution, working range of factors such as selecting the appropriate measuring instruments, and to establish Acquisition of measuring instruments management system, strict implementation of relevant government regulations.
2. Measuring instruments acceptance management
After the purchase of measuring instruments, it is necessary to accept them. Including anti-counterfeiting verification, shape, size, accuracy and other aspects of the test. Need to record the validation data in detail and establish a file.
3. Measuring instruments use and maintenance management
To ensure that the use of measuring instruments in the environment meets the requirements of use, carry out regular maintenance and repair. The establishment of measuring instruments and the use of specifications (standard operating procedures) SOP document to ensure that each measuring instrument to receive standardized maintenance and use.
4. Calibration and inspection of measuring instruments management
The establishment of measuring instruments should be regularly calibrated or inspected program to ensure that the instrument is always in a normal and accurate state. Calibration of measuring equipment need to follow standard procedures, and record and inventory of calibration results.
5. Measuring instruments update elimination management
When the measuring instruments exceed the limited service life, or can no longer be repaired, they need to be eliminated. At the same time, it is necessary to formulate a renewal plan for the integration and elimination of old equipment, and timely update the import of relevant machinery and equipment.
6. Measuring Instrument Records Management
The use of all key instruments and equipment and verification, calibration, etc. should be archived and filed. In the pharmaceutical industry, the integrity and credibility of the quality labeling is particularly important, when the quality of products have objections, measuring instruments records will be used as evidence for compensation or investigation.
7. Safety management of measuring instruments
Compliance with electrical / mechanical and other safety norms, to ensure the safety of workers' operations. And strengthen the locking of cabinets, temperature control, anti-dulling equipment, ventilation and other facilities maintenance, to ensure that no accidents occur in the production process.
The stability and accuracy of the management of measuring instruments in the production and inspection of pharmaceutical products is very important to solve the following problems:
1) Accuracy: to ensure the precision and effectiveness of product quality.
2) Economy: through the development of the renewal program, try to ensure that the equipment of the long-term value of each.
3) reliability: to reduce the instrument failure rate and the possibility of accidents caused by poor operation.