Good Drugs Storage Practices in Distribution Warehouses

The quality of medical product should be maintained throughout their shelf life and storage play a crucial role in this process. Storage of medicinal product is not only just providing the physical space for keeping the material but it also includes maintaining the environment that would not impact the quality of the medicinal product. It also includes the handling of the material in a way that do no effect its efficacy, integrity, physical safety etc. All the pharma guidelines do discuss a lot about the Good Storage Practices in the warehouses of the manufacturing premises but none discuss majorly about the Good Drugs Storage Practices in the distribution warehouses.

In the present article we will discuss about the various requirements of Good Drugs Storage Practices for distribution warehouses be it a warehouse of marketing firm, Distributor, Stockiest or retailer etc and the advantages it will have when stored as per the good practices.

GOOD STORAGE PRACTICES

A. Premises and Controls:

1. Storage areas should be appropriately designed, constructed, maintained or adapted.
2. Storage areas should be of sufficient capacity to allow orderly storage of the various categories of products. Wherever necessary proper demarcation should be done to store different categories of products separately to avoid mix-ups.
3. Finish Good material should be handled and stored in such a manner as to prevent contamination and mix-ups.
4. Storage areas should be kept clean and there should be sufficient space, ventilation and lighting.
5. Materials and medical products should be stored off the floor using pallets or racks. Appropriate distance should be ensured from walls and ceilings.
6. Suitable pallets should be used and kept in a good state of cleanliness and repair.
7. Materials should be protected from direct sunlight and suitably spaced, to permit ventilation, cleaning and inspection.
8. Provisions for storage of temperature sensitive goods should be provided.
9. Stock should be appropriately rotated. The “first expired/first out” (FEFO) principle should be followed.
10. A record that identifies the location of the stored good should be maintained for easy tracking of the goods.
11. Narcotic medical products should be stored in a secure, clearly identified and segregated area. The list of approved personnel working in the area should be displayed to avoid unauthorized personnel entering the premises. The access to the area should be under Lock and Key every time except when material is being transferred in the area. The Key to the area should be under the direct supervision of Warehouse Manager. Key issuance record shall be maintained if possible.
12. Broken or damaged items should be withdrawn from usable stock and separated.
13. The expired drugs shall be immediately separated from the stock and shall be kept separately under Lock and Key. The list of approved personnel working in the area should be displayed to avoid unauthorized personnel entering the premises. The access to the area should be under Lock and Key every time except when material is being transferred in the area. The Key to the area should be under the direct supervision of Warehouse Manager. Key issuance record shall be maintained if possible.
14. The area where expired goods are stored shall be prominently labelled as “Not for Sale”. The information regarding expired stocks shall be shared with the management. The stocks shall be returned/ disposed off as per the management’s directives.

B. Environmental conditions and monitoring:

1. Storage areas should be maintained within acceptable and specified temperature and humidity limits.
2. The finish product should be stored at the storage condition stated on the label or as described by manufacturer. Various types of storage conditions as mentioned on the label and there generally accepted temperature ranges are enlisted below. However, in case temperature and humidity ranges are specifically mentioned, the said conditions should be followed.

3. Temperature and relative humidity, as appropriate, should be controlled and monitored at regular intervals.
4. Data should be recorded in a log sheet by warehouse supervisor and duly approved by the warehouse manager. Discrepancy if any shall be immediately addressed.
5. In case of any fault in the instrument responsible for controlling temperature and humidity, they shall be immediately repaired or replaced as applicable.
6. All the important instruments/ equipment used for monitoring various parameters such as weight, temperature, humidity, lux meter etc. if applicable should be calibrated regularly. The operating range of all the instruments should be suitable for its intended use.

C. Personnel, Training and Hygiene:

1. Adequate number of personnel with the necessary qualifications and practical experience should be employed. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality and warehouse management.
2. Job responsibilities should be clearly defined for each individual.
3. Training should be imparted to all individuals according to their job profile.
4. All employees should maintain general level of hygiene.
5. General medical tests shall be carried out as per HR policy.
6. Smoking, eating, drinking, chewing, and keeping plants, food, drink, smoking material etc should not be permitted in the storage areas.

D. Ancillary Areas:

1. Facility for changing and storing clothes may be provided as per the company policy
2. Toilets, washing, restrooms and canteen facilities should be separate from areas where products are stored.
3. Food, eating, drinking and smoking should be prohibited in all areas where products are stored or handled.

E. Sanitation and Pest Control:

1. A written sanitation programme should be available, indicating the frequency of cleaning and the methods to be used to clean the premises and storage areas.
2. There should be appropriate procedures for the clean-up of any spillage, to ensure complete removal of any risk of contamination.
3. Premises should be protected from the entry of birds, rodents, insects and other animals.
4. A rodent and pest control programme should be in place.
5. Fly catchers, Roda boxes etc should be installed at the entrances of the warehouse.

F. Safety:

1. There should be a written procedure for fire control, including prevention of fire, fire detection and fire drills.
2. Fire-detection and firefighting equipment should be available and should be serviced regularly.
3. The access in the storage premises should be limited. Where ever necessary list of approved personnel working in the area should be displayed to avoid unauthorized personnel entering the premises.

ADVANTAGES

Storing material as per Good Storage Practices has many advantages and some of them are listed below:

1. Good storage practices helps in Inventory management.
2. As the drugs comes with a shelf life, hence, it is important that the material are dispatched as per the concept of First Expiry First Out. Good storage practices helps in the achievement of the same
3. Good Storage Practices ensures that the drugs are stored as per their requisite storage conditions.
4. Good Storage Practices helps to ensure that the drugs are saved from other damages like fire, water logging etc.
5. Good Storage Practices protects good from tampering and theft.

REFERENCE(S):

1. WHO TRS 1025 – Annex 7: Good storage and distribution practices for medical products.
2. Drugs and Cosmetics Act, 1940