Qualification of the refrigerating chamber

There are many international regulations (GMP, GDP, and GSP) stating that storage conditions for pharmaceutical products should be consistently maintained. The purpose of cold chamber qualification is to ensure that storage conditions for pharmaceutical products and materials meet the information indicated on the label. 

Cold chamber qualification is the process of providing documented evidence that storage conditions for products are maintained in all areas of a cold chamber, on each shelf, and in the places where products are stored. Distributors of medicinal products should have a quality system in place ensuring that storage conditions for medicinal products are constantly maintained, including during transportation … 

EC Guidelines on Good Distribution Practice of Medicinal Products for Human Use 

Storage conditions  

4.17 Storage conditions for pharmaceutical products and materials should be in compliance with the labeling, which is based on the results of stability testing and takes into account storage temperature and relative humidity 

WHO Report 908, Annex 9, Guide to good storage practices for pharmaceuticals 

Cold chamber qualification stages  

Installation Qualification (IQ) involves the following activities:  

  • Reviewing operation and maintenance documentation; 

  • Checking calibration of measuring instruments; 

  • Verifying proper installation, appearance, and configuration of cold chamber refrigeration systems. 

Operation Qualification (OQ) involves the following activities: 

  • Verifying that work instructions (SOP) are available. Checking the correctness of documentation and its compliance with the relevant requirements; 

  • Checking control panel components; 

  • Checking established equipment parameters; 

  • Checking operation and performance of critical alarm systems; 

  • Monitoring dynamic temperature distribution during the door opening time. Determination of the optimum time for which a door can remain open and the time taken for temperature recovery after a door opening;  

  • Determining the time taken to maintain the specified temperature range in the case of an emergency (power failure). 

Performance Qualification (PQ) involves the following activities: 

  • Monitoring external conditions and environmental conditions. Determining stability and reliability of cold chamber refrigeration system operation; 

  • Monitoring the ability to maintain stable temperatures (temperature mapping). Calculation of mean kinetic temperature (MKT). Determination of hot and cold spots. Determination of uniformity of the temperature distribution within a cold chamber; 

  • Checking monitoring system operation. Verification (determination) of monitoring points. 

Upon cold chamber validation (qualification), you will receive: 

Qualification protocol is a document describing qualification activities to be performed for testing as well as defining specific parameters to be assessed, acceptance criteria of each of these parameters, assessment criteria, methods of measurement and measuring instruments, including information about their precision, verification and calibration. 

Qualification report is a document in which the results of completed qualification activities, initial information about the qualification object, analysis of obtained data, proposals for conducting requalificationand conclusions are assembled. 

All documents provided comply with the requirements of national and international GMP, GDPand GSP standards. 

Qualification of the installation, operation and maintenance of cold rooms according to international standards

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