What are the requirements for temperature and humidity transmitters in the new version of GSP for medical warehouses?

New version of GSP drug warehouse temperature and humidity monitoring (part)

The requirements of the "Pharmaceutical Goods Management Practice (Revised in 2012)" (hereinafter referred to as the "Code") are as follows

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Article 1: Enterprises shall, in accordance with the requirements of the "Good Manufacturing Practices for Pharmaceuticals (Revised in 2012)" (hereinafter referred to as the "Specifications"), be equipped with temperature control equipment in the warehouses that store medicines and in the equipment that transports refrigerated and frozen medicines. The humidity monitoring system (hereinafter referred to as the system) performs real-time automatic monitoring and recording of the temperature and humidity conditions during drug storage and the temperature conditions during refrigerated and frozen drug transportation, effectively preventing various types of conditions that may affect drug quality and safety during storage and transportation. risks, ensuring the quality of pharmaceutical products during storage and transportation.

Article 2: The system consists of measuring point terminal, management host, uninterruptible power supply and related software. Each measuring point terminal can collect, transmit and alarm real-time data on the temperature and humidity of the surrounding environment; the management host can collect, process and record the monitoring data of each measuring point terminal and has an alarm function.

Article 3: The measurement standard value of system temperature and humidity data shall be set in accordance with the relevant provisions of Article 85 of the "Specifications".

Article 4 The maximum allowable error of system temperature and humidity measurement equipment shall meet the following requirements:

(1) The measurement range is between 0℃ and 40℃, and the maximum allowable error of temperature is ±0.5℃;

(2) The measurement range is between -25℃~0℃, and the maximum allowable error of temperature is ±1.0℃;

(3) Relative humidity The maximum allowable error is ±3%RH.

Article 5: The system should automatically and continuously monitor and record the temperature and humidity environment during drug storage and transportation. The system should update the temperature and humidity data of the measuring point at least every 1 minute, automatically record the real-time temperature and humidity data at least every 30 minutes during the storage process, and automatically record the real-time temperature data at least every 5 minutes during the transportation process. When the monitored temperature and humidity exceed the specified range, the system should record real-time temperature and humidity data at least every 1 minute.

Article 6 When the monitored temperature and humidity data reaches the set critical value or exceeds the specified range, and the system experiences power supply interruption, etc., the system should be able to implement sound and light alarms on the spot and at designated locations. At the same time, SMS communication and other means will be used to call the police on no less than 3 designated persons.

Article 7: The monitoring data collected by terminals at each measuring point of the system should be true, complete, accurate and effective.

(1) The data collected by the measuring point terminal should be automatically transmitted to the management host through the network for processing and recording, and the data should be saved in a reliable way to ensure that it will not be lost or altered;

(2) The system should have the function of not changing or deleting the recorded data, and should not set up the function of reverse import of data;

(3) The system should not open the temperature and humidity correction parameter adjustment function to users. , to prevent users from arbitrarily adjusting calibration parameters and causing distortion of monitoring data.

Article 8: Enterprises shall back up monitoring data on a daily basis in a safe and reliable manner. The backup data shall be stored in a safe place, and the data storage period shall comply with the requirements of Article 42 of the "Specifications".

Article 9: The system should be connected to the enterprise computer system, automatically store data in the computer system, and conduct real-time data query and historical data query through the computer terminal.

Article 10: The system should have emergency safeguard measures and can operate independently and uninterruptedly. The normal operation of the system or data loss cannot be affected by factors such as power supply interruption, computer shutdown or failure.

Article 11 The system shall maintain independent and safe operation and shall not be linked with temperature and humidity control facilities and equipment to prevent the risk of system failure caused by abnormalities in temperature and humidity control facilities and equipment.

Article 12 The number and location of measuring point terminals installed in pharmaceutical warehouses and transportation equipment should be able to accurately reflect the actual conditions of temperature and humidity. Enterprises should test and confirm the measurement point installation plan for storage facilities, and verify the measurement point terminal installation plan for refrigerated, frozen storage and transportation facilities and equipment.

Article 13 The number and location of measuring point terminals installed in a pharmaceutical warehouse or warehouse shall meet the following requirements:

(1) Each independent pharmaceutical warehouse or warehouse shall install at least 2 measuring point terminals.

(2) At least one monitoring terminal should be installed for every 300 square meters of the flat warehouse, and at least one measuring point terminal should be added for every additional 300 square meters of area. If the area is less than 300 square meters, it will be calculated as 300 square meters.

The installation position of the measuring point terminal in the flat warehouse shall not be lower than 2/3 of the height of the drug shelf or drug stack.

(3) If the shelf height of the elevated warehouse or fully automatic three-dimensional warehouse is between 4.5 meters and 8 meters, at least 2 measuring point terminals should be installed per 300 square meters and evenly distributed on the shelves. , lower position; if the shelf height is more than 8 meters, at least 3 measuring point terminals should be installed for every 300 square meters of area, and evenly distributed at the upper, middle and lower positions of the shelf; if the shelf is less than 300 square meters, it will be calculated as 300 square meters.

The installation position of the measuring point terminal on the upper level of the elevated warehouse or fully automatic three-dimensional warehouse shall not be lower than the highest position of the uppermost shelf where the medicines are stored.

(4) The installed quantity of measuring point terminals in refrigerated and frozen drug warehouses shall comply with the above requirements of this article, and the unit for calculating the installed quantity shall be calculated per 100 square meters of area.

Article 14 The number of temperature measuring point terminals installed on each independent refrigerated or frozen pharmaceutical transport vehicle or compartment shall not be less than 2. If the compartment volume exceeds 20 cubic meters, at least one measuring point terminal will be added for every additional 20 cubic meters. If the compartment volume is less than 20 cubic meters, it will be calculated as 20 cubic meters.

Each refrigerator or incubator should be equipped with at least one movable measuring point terminal.

Article 15 The installation location of measuring point terminals should consider factors such as the structure of the warehouse, air outlets, doors and windows, radiator distribution, etc., to prevent unreasonable installation locations from affecting the accuracy of environmental temperature and humidity monitoring. sex.

Article 16 Measuring point terminals should be firmly installed and reasonably positioned to effectively prevent storage and transportation equipment operations and personnel activities from affecting or damaging monitoring equipment. The installation position of measuring point terminals must not be adjusted at will.

Article 17: Enterprises shall calibrate measuring point terminals at least once a year, conduct regular inspections, repairs, and maintenance of system equipment, and establish files.

Article 18: The system should be able to meet the conditions for relevant departments to implement online remote supervision.

Article 19: Enterprises responsible for the entrusted storage and distribution of drugs shall comply with the provisions of this appendix. Enterprises entrusting drug transportation shall conduct an audit of the quality assurance capabilities of the enterprises to be entrusted in accordance with the requirements of the "Specifications" and this appendix. Those that do not meet the requirements shall not be entrusted with transportation.

(1) The items that need to be verified in drug storage warehouses or warehouses should at least include the following:

1. Testing and analysis of temperature distribution characteristics, and analysis of temperature distribution exceeding the specified temperature limit Location or area, determine the safe location and area suitable for drug storage;

2. Test the operating parameters and usage conditions of temperature control facilities;

3. Temperature monitoring points configured in the temperature control system Confirmation of parameters and installation location;

4. Determine the impact of door-opening operations on temperature distribution and changes in the warehouse according to actual operating conditions;

5. Test experiments on power outage conditions to determine equipment failure or Analysis of warehouse insulation conditions and changing trends when external power supply is interrupted;

6. Verification of the insulation effect under high and low temperature conditions in extreme external environments in the region should be done at least twice a year;

< p>7. Before the warehouse is put into use or after renovation, no-load verification should be carried out, and full-load test verification should be done during regular verification.

3. Overview of the temperature and humidity monitoring system for drug storage

(1) System composition

A comprehensive temperature and humidity monitoring system mainly consists of the following parts (Some products are optional):

1. Temperature and humidity transmitter, power adapter, communication converter, control converter, sound and light alarm, UPS, industrial computer,

Monitors, communication cables and auxiliary facilities required for construction, etc.

2. Temperature and humidity monitoring software: According to actual monitoring needs, temperature and humidity monitoring software that implements various functions is provided.

(2) System functions and features

1. System software functions: Real-time monitoring of temperature and humidity in the monitoring area, data flashing voice alarm, SMS alarm, and phone dialing are realized through monitoring software Alarm, remote automatic control (such as the start and stop control of air conditioners, humidifiers, dehumidifiers, fans and other equipment are optional), real-time curves, historical curves, data reports, data storage, printing, data transfer to TXT, EXCEL, etc.

2. System hardware functions: On-site LCD temperature and humidity measurement value display with backlight, on-site sound and light alarm, air conditioning, humidification/dehumidifier, fan control, other functions can be customized as needed. The system runs on industrial computers with current mainstream configurations. The system supports operating systems from win98 to the latest win7. It has very good compatibility and can run smoothly under different configurations and operating systems.

3. Support multiple networking methods: The system supports various current communication methods such as 485 bus, Ethernet, GPRS wireless network, free band wireless network, etc. One or more of them can be selected for different sites. In this way, flexible and convenient networking can be realized, and the system architecture can be optimized, simplified and practical.

4. Rich user management functions: Set different management permissions according to the user's different operating permissions to realize partitioning, grading, and permission-based software operation management. People with high authority can view various types of software in different areas. parameters, and can modify related parameters. Those with lower authority can only view the data in the specified area and modify the parameter settings.

5. Standardized and vivid software interface: The system is developed using a configuration software platform. It has the characteristics of rich functions, stable performance, vivid and beautiful interface. It can draw electronic maps, monitoring point distribution maps, etc. as needed. , to achieve the effect of accurate monitoring location and clear monitoring objects, ensuring that when an alarm occurs, the alarm location is accurately located as quickly as possible so that timely and effective processing can be made.

6. Convenient system upgrade, system expansion, and maintenance: Modular management facilitates software upgrades, system expansion, and daily maintenance.

7. The system provides an interface (Open Database Interconnection Interface (ODBC)) with other system platforms to easily realize data interaction with other systems and achieve maximum sharing of monitoring information.

8. You can choose an LED electronic screen or a large-area LCD display as needed, which can be placed in the monitoring center or other locations to facilitate viewing of temperature and humidity data or used as a public information billboard.

9. The system is divided into stand-alone version and network version in terms of network access mode. The stand-alone version software does not support network access and only allows monitoring and management of temperature and humidity data on the computer running the monitoring system. Stand-alone version The online version is suitable for relatively independent regional monitoring; the online version supports viewing and managing temperature and humidity data through a remote computer through an internal network or the Internet. The online version is suitable for remote monitoring and management of multiple regions that require decentralized and centralized supervision. application.