Warehousing & Logistics

Al Jeel’s warehouses are organized according to SFDA requirements for storage and transportation.

Storage of medical devices


1. Storage area:
Storage areas designated for the storage of medical devices are designed as follows:
- The area is clean and dry.
- The area is suitably spaced to allow cleaning and inspection.
- All surfaces and shelves are made of/covered by an impermeable material to enable proper and safe cleaning.
- Areas are adequately lit and ventilated in order for tasks to be performed in a correct and safe manner.
Storage area has the appropriate license from the Ministry of Municipal and Rural Affairs and the General Directorate of Civil Defense.

2. Traceability in the storage area:
In case of a recall by the manufacturer or the SFDA, Al Jeel is able to trace a product in the storage area by its lot/batch/serial number and be able to specify the quantity still available in the storage area of a given lot/batch/serial number.

Al Jeel monitors the expiry dates of products in the storage area through periodic inventories to avoid unintended dispatch of expired products.

3. Damaged, expired or recalled products:
There is physically separate area for keeping damaged, expired or recalled products. This area is clearly labeled and controlled to prevent the use of these products until a final decision is taken on their fate. Other means of segregation shall be considered if proven to effectively prevent mix-up.

Transportation of medical devices


Vehicles used to transport medical devices are properly designed and equipped to ensure protection from different environmental and weather conditions in which it operates.

Manufacturer requirements:


All medical devices are stored, handled and transported under conditions specified by the manufacturer to prevent deterioration. These conditions might be related to one or more of the following:
- Temperature
- Moister and humidity
- Exposure to light
- the direction the package should face
- the maximum number of packages stacked above each other

If the manufacturer require products to be stored or transported at certain conditions (e.g. temperature and humidity), these conditions shall be monitored and periodically recorded. Such records shall be available for review.

If the packaging labels does not include information about the required storage and transportation conditions of a medical device, it is Al Jeel’s responsibility to obtain such information from the manufacturer.

Temperature:
All the products are kept during storage and transportation at temperature ranges specified by the manufacturer. These temperature ranges are maintained in the receiving/preparation areas if the products are to be kept there for more than one hour.

If the manufacturer require products to be stored or transported at certain temperature ranges, these ranges shall be monitored and periodically recorded. Temperature monitors are to be placed where temperatures are most likely to fluctuate or rise.

Sterile products:


In addition to manufacturer-specific requirements, products that are dispatched in a sterile state are generally stored, handled and transported in a manner that protects its packaging from exposure to moisture, direct sun-light and damage to ensure they are still sterile when received by the customer. Sterile products are considered unsterile if packaging loses its integrity

Staff:

Staff involved in the storage, handling and transport of medical devices have appropriate knowledge about the storage, handling and transport requirements of all the products with which they deal. If products with different requirements are to be stored or transported under different conditions, the involved staff is able to sort such products based on their storage and transport requirements.

Written procedures:


Al Jeel has a written procedure that describes the practices taken to ensure the devices are stored, handled and transported based on their manufacturer requirements.

The procedure:
- Is part of a quality management system and includes the records and controls such a system requires;
- identifies a member of staff responsible for ensuring the manufacturer’s requirements for the storage, handling and transport of its medical devices are identified and properly implemented; and that all personnel involved in such activities have the appropriate experience and training to undertake the duties assigned to them;
- where the organization imports or distributes medical devices from more than one
- manufacturer, identifies the range of different requirements and accommodates them all within the procedure;
- ensures that medical devices are stored apart from other goods and under conditions complying with the instructions of the manufacturer, in particular, concerning ambient humidity, temperature and light requirements;
- ensures that storage and transport conditions will prevent damage, deterioration or other adverse effects of the medical devices pending their distribution; and are properly monitored and, where appropriate, recorded;
- specifies the action to be taken in the event of deviations from the required storage or transport conditions;
- describes the storage area, and the method used to include a secure area/s within it for the purpose of storing separately:
- 1. any quarantined medical devices or, where necessary
- 2. devices incorporating dangerous and/or hazardous substances;
- incorporates a system to ensure the medical device inventory is properly rotated (i.e. either ‘first in …… first out’ or ‘expiration date’ driven) and that any device exceeding its expiry date, or shelf life, is quarantined;
- incorporates a procedure to quarantine devices subject to a recall and/or field safety corrective action or to identify non-defective devices that have been returned from a user or other organization from other inventory until a decision on further action has been reached in cooperation with the manufacturer;
- ensures that medical devices are properly packed, handled and stored for transportation as well as transported in a suitably vehicle, taking into account the manufacturer’s instructions with respect to temperature, humidity, vibrations and the risk of physical damage. Ensures that these factors are properly monitored and, where appropriate, recorded during transportation.