But now a little more standardized enterprises, ordinary drugs are basically not much cash transactions.
Expanded Information
GSP Pharmaceutical Management Standard
According to the State Food and Drug Administration's Bulletin No. 38 of the five appendices in the fifth appendix of the validation of the management of the validation of the requirements of the provisions of the pharmaceutical business unit requires the pharmaceutical warehouses, cold storage, refrigerated boxes and refrigerated boxes. The cold storage, refrigerator and warming box for temperature and humidity verification or temperature verification, confirm that the relevant facilities, equipment and systems can meet the prescribed design standards and requirements, can be safe, effective and normal operation and use, to ensure that refrigerated, frozen drugs in the storage, transportation process of the quality of drugs. Cold chain validation is divided into "pre-use validation, special validation, periodic validation and validation of out-of-service time exceeding the specified time limit".
The requirements for verification equipment are as follows:
The temperature equipment used for verification should be calibrated by the statutory measurement organizations, and a copy of the calibration certificate should be used as a necessary annex to the verification report. Verification of the use of temperature equipment should be applicable to the measurement range of the equipment being verified, the maximum allowable error of its temperature measurement is ± 0.5 ℃.
I, drug GSP verification program is generally divided into:
1, GSP cold storage verification;
2, GSP refrigerated truck verification;
3, GSP refrigerated warming box verification;
4, GSP drug warehouse temperature and humidity monitoring system verification.
Second, the new version of the GSP drug cold chain validation program;
1, cold storage temperature validation program;
2, refrigerated truck temperature validation program;
3, holding tanks, refrigerated box temperature validation program;
4, drug warehouse temperature and humidity validation program.
Three, the new version of the GSP verification of the deployment requirements:
(a) in the facilities and equipment to be verified by a one-time synchronization of the deployment, to ensure that the measurement of the data collected by the synchronization of the point, effective.
(ii) in the validated facilities and equipment, uniformity of the distribution point, special projects and special location of the special distribution point.
(c) the number of uniformity points in each warehouse shall not be less than nine, the warehouse corners and the center of the position are required to arrange the measurement point, the horizontal spacing of each of the two measurement points shall not be greater than 5 meters, the vertical spacing shall not exceed 2 meters.
(d) each operation of the warehouse and fan outlets at least five measurement points, each group of shelves in the warehouse or the building structure of the wind direction of the dead center position at least three measurement points.
(e) each refrigerated truck box the number of measurement points in the body shall not be less than 9, each increase of 20 cubic meters to increase the number of 9 measurement points, less than 20 cubic meters of 20 cubic meters according to 20 cubic meters. (F) the number of measurement points in each refrigerated box or insulation box shall not be less than 5.
Four, the new version of the GSP validation time requirements:
(a) in the warehouse parameters and conditions of use in line with the specified requirements and to achieve operational stability, the data shall not be less than 48 hours of effective and continuous collection time.
(ii) in the refrigerated truck to achieve the specified temperature and operational stability, the data effective continuous collection time shall not be less than 5 hours.
(iii) After the reefer or holding tank has been preheated or pre-cooled to the specified temperature and is fully loaded and boxed, the data is collected continuously in accordance with the longest delivery time.
(iv) The interval between validation data collection shall not be greater than 5 minutes.
Answer reference to the Zhihu author: Yang Yuan Refrigeration.