Description
Storage Qualification and Temperature Mapping
<> Qualification of warehouses in pharmaceutical companies is carried out to confirm that the storage conditions of products meet the established requirements for temperature and humidity. When introducing a system for continuous monitoring of temperature and humidity, as well as during commissioning, temperature mapping of the warehouse should also be carried out.
Storage engineering systems (heating, ventilation, air conditioning) must maintain temperature and humidity within certain limits throughout the entire warehouse, regardless of external conditions, day of the week or season.
The main regulatory documents governing the qualification of warehouses
WHO Recommendation, Appendix 5 WHO Technical Report Series, No. 992, 2015
Decision of the Council of the EEC dated 03.11.2016 N 80 "On approval of the rules of good distribution practice in the framework of the Eurasian Economic Union"
Order of the Ministry of Industry and Trade of Russia of June 14, 2013 No. 916 “On Approval of the Rules of Good Manufacturing Practice (as amended by Order of the Ministry of Industry and Trade of Russia of December 12, 2015 No. 4148)”.
Order of the Ministry of Health of Russia dated August 31, 2016. No. 646n "On approval of the Rules of Good Practice for the Storage and Transportation of Medicines for Medical Use".
OFS 1.1.0010.15 "Storage of medicines"
Warehouse qualification work
As a rule, the warehouse qualification is held at least twice a year (during the cold and warm period), as well as when making changes in the design of warehouse premises (zones) or operating modes of engineering systems of the year, and includes the stages of DQ, IQ, OQ and Pq.
For new and reconstructed warehouses, the project should be qualified to confirm that the technical solutions incorporated in the project meet the initial requirements and can provide the necessary storage conditions.
At the IQ stage, as a rule, verification of the availability of project documentation, control of installation and verification of the availability and compliance of measuring instruments and other technical solutions of project documentation are carried out.
Qualification of a warehouse in an equipped state (OQ) includes:
control of external conditions (temperature, humidity);
temperature mapping - monitoring the uniformity and stability of maintaining temperature and humidity when the warehouse is loaded - for 72 hours in three repetitions in a row.
Equipment used in warehouse mapping
During the qualification of warehouses, temperature and humidity loggers are used to ensure measurement accuracy in accordance with the recommendations of the World Health Organization (WHO Technical Report Series, No. 992, 2015, Annex 5):
Temperature measurement accuracy: ± 0.5 ° C with a range from –20 ° C to + 70 ° C;
Accuracy of measurement of relative humidity: ± 3% RH (2 - 98% RH).
In addition to the data from the temperature and humidity sensors, a thermal imaging survey of the warehouse can be carried out, clearly showing the places of heat losses and areas with uneven temperature distribution.
Temperature mapping and risk analysis
At the stage of putting storage facilities into operation, as well as to introduce a system for continuous monitoring of temperature and humidity, temperature mapping of the warehouse is carried out, allowing to assess the uniformity of temperature distribution, stability of temperature maintenance, determine critical zones, as well as places for installing sensors of continuous monitoring system.
The cost of work on the qualification of warehouses and temperature mapping
The cost of temperature mapping and qualification of work depends on the size of the warehouse and the types of work required (mapping, risk analysis, qualification, re-qualification). Send a request, and we will quickly calculate the cost of the work.
