The Qualification can be broadly broken down into 4 sections.

Qualification of temperature controlled storage areas, in GMP companies, will most commonly follow ISPE’s GAMP approach where the qualification is divided into 4 stages. Depending upon the complexity of the system some stages can be merged or not even required at all.
  1. Design Qualification (DQ) – To ensure everything is going to meet the end users’ requirements. Not much point in starting to qualify/validated something under the wrong conditions or using the wrong equipment. Write and agree on a URS and protocol.
  2. Installation Qualification (IQ) – Make sure all your equipment (loggers, environmental chambers, Temperature mapping reports, etc) is within calibration limits and in good, reproducible working order.
  3. Operational Qualification (OQ) – Start testing your products under the predefined conditions but empty or “not loaded”. Minimum tests.
  4. Performance Qualification (PQ) – Start testing full systems under predefined conditions. Maximum tests.

Qualification applied to temperature-controlled storage areas

Qualification is commonly used to validate pharmaceutical manufacturing processes but it can also be applied to the pharmaceutical supply chain in general, and to temperature-controlled storage processes and equipment in particular.
In this context, temperature-controlled storage covers any area where sensitive pharmaceutical products have to be stored within a controlled temperature range (e.g. 2.0 °C to 8.0 °C or 15.0 °C to 25.0 °C).

Qualification Protocols

During this phase prepare, review, and approve a detailed and comprehensive protocol before the qualification process begins. It should include, at a minimum the following topics: Description and rationale, Scope and objectives, Key parameters, Procedures, and Qualification report template. It should also include an Approval page and change control history for traceability, transparency, and good record-keeping.

Equipment (IQ)

Electronic data logging monitors (EDLMs), should have a 3-point calibration certificate and have a guaranteed error of no more than ±0.5 °C at each calibration point. This is part of IQ and should be completed after the URS and Protocol are finalized. Environmental chambers (refrigerators, freezers, and other equipment) should be calibrated to acceptable limits before OQ begins. After calibration, these components can be checked with a pass/fail test compliance check before each experiment commences. This can be achieved by temperature mapping to demonstrate that the chamber is capable of controlling and maintaining a uniform temperature when the storage area is empty. Identify any critical components and have backup or contingency plans if these components fail during the experiment.

Operational Qualification (OQ)

The purpose of OQ is to establish that the thermal storage device, all its systems, and sub-systems operate effectively and consistently when the storage area is empty. There should be a comprehensive set of SOPs which cover all relevant aspects of the installation, routine operation, and maintenance of the system/installation. Consider this a simulated test of what the system will experience in the outside real-world environment. As soon as the OQ process has been completed and the exercise has been approved, the next step is the Performance qualification (PQ) stage, with the storage area fully operational.

Performance Qualification (PQ)

The purpose of PQ is to establish that the installation and all its systems and subsystems operate effectively and consistently when the storage area is fully operational (in use, loaded with TTSPPs). Before commencing a PQ the following areas should be inspected:
  1. Check that all controllers and sensors are correctly calibrated.
  2. Carry out a temperature mapping of the storage area loaded as in normal operations.
  3. Test and record temperature recovery following a door opening during normal operation.
PQ is normally carried out immediately after satisfactory completion of the IQ and OQ stages. Once the entire OQ and PQ process has been successfully completed and all deviations have been corrected, the installation can be signed off and fully released for routine operation.

Qualification Report

When the PQ assessment has been completed, prepare a report.
  • Make sure that all of the sections included in the PQ protocol have been completed, signed, and dated.
  • Record all deviations from the installation drawings and specifications in the deviation report section. Make sure that each deviation is cross-referenced to the relevant sections of the PQ protocol.
  • Transcribe any handwritten notes made by the PQ team into the relevant sections of the report.
  • Specify the actions that need to be taken to correct the reported deviations and state the person or organization responsible for completing these actions.
  • List all members of the qualification team and their designations.
To read more about The WHO’s Annex 9 Supplement 7: Qualification of Temperature Controlled Storage Areas, click here. The WHO has written several great informative guidelines on Good Distribution Practices (GDP). Anyone working in the industry should acquaint themselves with these documents. See the list of them here.
CoolPac is a specialist in GMP Cold Chain. We can help you with the qualification of the storage area or simply help you with the qualification by doing the temperature mapping of the area. CoolPac also supplies much of the packing systems needed to transport temperature-sensitive medicines.