In handling physical pharmaceutical goods, the very important factor which should be concerned is temperature. Especially for distribution, this means to maintain condition in accordance with result of stability test, started from production process until its usage by patient. 

Cold Chain Product (CCP) especially to occupy the first rank for tight supervision toward temperature condition. Ranging between 2°C until 8°C (chilled temperature) must be met either at storage condition or during transportation.

Referring to GDP (Good Distribution Practice) standard can be seen that to reach fulfillment requirements of handling pharmaceutical products (especially CCP), not only facility and storage facility should be concerned, but also process and handling method, as well as manpower aspect.

Following are some critical points in handling Cold Chain Product

1. Storage 
Storage shall be performed at place with temperature 2°C until 8°C (chilled temperature), such as Cold Storage, Chiller, or refrigerator. In some guidelines issued by the Ministry of Health in another country, local refrigerator is used for long term storage.

Some matters which are usually conducted to maintain temperature at stable condition are:
- Performs qualification and analysis temperature distribution at cold storage place 
- Install insulated strip curtain at chiller / cold storage door to avoid drastic temperature increase when the door is opened
- Install alarm (warning system) to detect temperature deviation 
- Install digital thermostat for regulating cooler engine work more accurate
- To provide checklist and periodical maintenance activity to give assistance to warehouse personnel.

Observation to temperature is very important in storage phase because deviation can mean lessening product storage age or even goods damage. In conducting observation of CCP storage temperature, some matters which can be done among others are:
- Make sure measurement equipment used has been calibrated
- Perform manual recording routinely 
- Perform observation whether there is frozen condition at storage place
- Conduct continual recording so that it can perform analysis toward temperature graphic continually (For example Thermometer

  Chart, Datalogger, etc)
- Conduct analysis toward performance trend of storage place, temperature equalization, min-max temperature and condition      

  during defrost. In process of observation of temperature, choosing, using and maintaining temperature measurement equipment

  also required to take into account the following:
- Annual calibration 
- Maximum deviation from result of annual calibration
- MPE (Maximum Permissible Error; Maximum deviation allowed). MPE is like two knife blade.

 

Figure stipulated for MPE shall be applicable either as criteria of calibration success or as temperature range criteria.
For example.: If we stipulate MPE of 1°C, then:
- Thermometer with maximum deviation of +/- 1°C still can be used 
- Storage temperature range decreases respectively 1°C at upper border and lower border becomes 3°C through 7°C
Too big MPE value shall decrease range allowed significantly, however too small MPE value shall decrease criteria of calibration acceptance.

2. Delivery 
To make sure requirements temperature still satisfied during delivery, then, it should take into account the following aspects:
- Delivery facilities

- Packing materials: Styrofoam box or Coolbox

- Cooling Element: Icepack with gel basic materials 

- Filling Element: Styrofoam sheet, shredded paper, etc

- Delivery temperature measuring equipment 

- Packing method shall be legalized 
- If it uses controlled temperature vehicle, transportation equipment also subject to qualification
- Arrangement transportation type that minimize delivery time 
- Goods procurement process also must be legalized. Maximum tolerance time and upper border temperature allowed during preparing goods relied upon Specific Requirements of handling each product. However, goods procurement process shall be designed in order not too long so that goods lied on deviating condition

3. Quality Control System 
In the field practice, to make sure operational which satisfies requirements continually, quality control system should cover:
- Availability procedure and occupational instruction which remain valid
- Realization periodical audit process toward system, process and infrastructure
- Realization improvement, prevention and sustainable perfection to the system
- Realization proper training which is suitable for worker and make sure appropriateness of qualification of manpower with detail of its work..

Chain power is as big as the weakest eye chain power. Each Party carries out CCP distribution is responsible to perform potential identification and position of deviation gap at throughout distribution points. The more important is human factor, Urgent feeling and awareness is very important to be realized by each personnel, either directly or not directly, involved in CCP distribution. (Rosariwaty Tedjokoesoemo)