The Compliance Paradigm

Rule 2.3.5.3(c) of the Rules relating to good pharmacy practice

The storage area must be kept clean. Internal air temperature distribution must be mapped on installation of the storage area while empty and thereafter fully stocked. This must be done annually under conditions of normal use.  Thermolabile pharmaceutical products must not be stored in areas shown by temperature mapping to present a risk (e.g. in the airflow from the refrigeration unit).

Rule 2.3.5.3(f) of the Rules relating to good pharmacy practice

A suitable number of temperature recording instruments that complies with or meets WHO specifications, being at least a logging device, must be installed to record temperatures and to provide temperature and profiles as per the temperature mapping of the storage area. Monitors that complies with or meets WHO specifications, must be adequate to monitor and record temperature ranges in all parts of the area within the specified temperature range.

Rule 2.3.5.3(l) of the Rules relating to good pharmacy practice

Any recording devices/instruments must be calibrated annually against a certificated standard.

Rule 2.3.5.3(g) of the Rules relating to good pharmacy practice

Temperatures must be monitored and recorded at least twice daily, with a minimum of seven hour interval and the records from such monitoring must be reviewed daily.

Rule 2.3.5.3(k) of the Rules relating to good pharmacy practice

The refrigerator, cold room or freezer must be connected to an alarm system and/or warning system in the event of a power failure or if the storage area temperature limits are exceeded.

Rule 2.3.5.3(a) of the Rules relating to good pharmacy practice

Thermolabile pharmaceutical products must be stored in a storage area, refrigerator or cold room, in a temperature regulated environment as per the information on the manufacturer’s product label indicating which temperature must be maintained at all times.

Rule 2.3.5.3(j) of the Rules relating to good pharmacy practice

The refrigerator, cold room or freezer must be connected to a standby generator or other emergency power system to ensure uninterrupted power supply in the event of power failure.

Rule 2.3.5.3(b) of the Rules relating to good pharmacy practice

The storage area must be large enough to allow for orderly arrangement of products, to permit air circulation especially between shelving and for proper product rotation. If it is filled to capacity, the effect on temperature distribution must be investigated.

Rule 2.3.5.3(m) of the Rules relating to good pharmacy practice

The refrigerator, cold room or freezer must be clearly designated and appropriately signed to store exclusively thermolabile pharmaceutical products.

Rule 2.3.5.3(d) of the Rules relating to good pharmacy practice

All storage areas, such as refrigerators or cold rooms must be properly maintained in order to maintain the factory standards for such storage areas. Proof of maintenance must be provided.

Rule 2.3.5.3(n) & 2.3.5.3(o) of the Rules relating to good pharmacy practice

2.3.5.3(n) Within a community or institutional pharmacy the storage area must be inside the pharmacy and must be easily accessible to the pharmacist and pharmacy support personnel and other authorised healthcare professionals.

2.3.5.3(o) Within a health facility (other than a pharmacy), any storage area for thermolabile pharmaceutical products must be easily accessible to the authorised healthcare professionals.