A- Handling of material at storage area
1- Stored material should be isolated according to its specified storage conditions mentioned on the label and in line with the risks in case personnel could be subjected to on handling. Inflammable materials should be kept in suitable room, or in a fire resistant safe lock, dangerous substances should be clearly identified and labeled ,this also applies on radioactive , narcotic substances and any substances that can impose a hazard when used improperly.
2- Narcotic ,psychotropic drugs and radioactive substances should be stored in a manner that complies with international regulations and U.A.E laws( federal law number 4 for year 1983 ,federal law 14 for year 1995 for narcotics and federal law No 20 for products derived from natural resources ) and the relevant MOH instructions.
3- All procedures involving the dealing with and distribution of pharmaceuticals should comply with the GMP regulations issued by the drug control department in the year 2000.
4- Starting material and products should be isolated and be properly labeled in a way which prevents mix-up and cross contamination.
5- Stored materials and products should be stored ( kept within containers) that:
Don’t affect the quality of products negatively.
Provide the proper protection from the surrounding environmental factors as well microbial contamination.
6- A system should be in place to ensure that pharmaceutical products due to expire first are sold and/or distributed first (FEFO). Adequate controls should be in place to prevent the distribution of expired products.
7- Broken or damaged items should be withdrawn from usable stock, separated and labeled clearly.
8- Items that require refrigeration should be kept in fridges a way that prevents cross contamination, fridges’ temperature should be recorded periodically to ensure its consistency within the required limits. The location of the storing fridges should be properly chosen.
9- Storage conditions for products and materials should be in compliance with the labeling, which is based on the results of stability testing approved by Drug Control department on the product’s registration.
B- Monitoring and control of storage conditions during storing and transportation
1- It is recommended that temperature monitors be located in areas that are most likely to show fluctuations according to a validated plan.
2- All recorded temperature and humidity monitoring data recorded out of continuous monitoring should be:
Available for review.
Comprise all the results of the regular checks made at suitable predetermined intervals recorded and retained from equipment designated for monitoring temperature degrees.
Kept for at least the shelf-life of the stored material or product plus one year.
Temperature mapping should show uniformity of the temperature across the storage facility or transporting vehicle.
C- Hygiene 1- Storage areas should be clean, and free from accumulated waste and vermin. A written validated sanitation program should be available indicating:
Frequency of cleaning
Methods to be used to clean the premises and storage areas.
Written program for pest control. The pest-control agents used should be safe, and there should be no risk of contamination of the stored materials and products. There should be appropriate procedures.
Written program for disinfection methods mentioning the periodic exchange of used disinfectants in a way prevents microbial resistance.
Written program for maintaining used cleaning tools (utensils) clean.
Procedures for the clean up of any spillage to ensure complete removal of any risk of contamination.
2- Training should be provided for cleaning personnel in a way that ensures their understanding of the importance of the cleaning procedures followed. 3- Washing station in the storing area should not be used for washing hands. 4- An instructions sign should be displayed stating the need for washing hands and the use of hot air and tissues for drying. 5- Toilets should not be used for storage purposes