Monday, June 22, 2009

Premises, Instruments and vehicles,pharmaceutical store

A- Premises:
1- Design and Layout of the storage site:
1-1 Storage areas should be designed or adapted to ensure the following good storage conditions:
 Proper cleanliness & Hygiene.
 Dry (relative humidity not more than 60%)
 Temperature should be within acceptable limits (8-25 degrees Celsius).
 Stored Goods and Materials should be stored off the floor
 Suitably spaced to permit cleaning and inspection.
 Pallets should be kept in a good state of cleanliness and repair.
1-2 Storing area should be sufficient to allow the storage of different items in orderly and separated avoiding jam packing. In this regards it is essential to designate separate areas for each of the following:
 Raw materials.
 Packaging material.
 Intermediate material.
 Finished product.
 Quarantined substances.
 Approved products.
 Rejected products.
 Recalled products.
 Returned products.
 Dangerous material.
 Inflammable substances.
1-3 Resting areas and areas for having food should be isolated from storing area. 1-4 Toilets and hand washing areas should be made available. 1-5 Toilets should not be opened directly into the storing area.
2- Specifications of the storage area
2-1 Precautionary physical arrangements and measurements should be taken in order to give access for those only authorized personnel to enter the storage area.
2-2 Storing area should have sufficient light to perform tasks in a correct, safe and accurate manner.

2-3 In case of windows presence in the storage area, arrangements should be made to block Sunlight away from the stored items.
2-4 All surfaces, shelves, cupboards used should be covered with an impermeable and easy to clean smooth layer.
3- Receiving and dispatching area:
 Receiving and dispatch bays should protect products from the weather.
 Reception areas should be designed and equipped to allow containers of incoming pharmaceutical products to be cleaned, if necessary, before storage.
4- Quarantine area:
Quarantined material and Pharmaceutical products should be kept in specified quarantine areas until approved. This area should be:
 Well isolated, separated and clearly labeled.
 Restricted only for authorized personnel.
 Any system replacing physical quarantine should provide equivalent security, isolation and prevention of mixing up, provided that it is validated to demonstrate its effectiveness and security of access.
5- Sampling area:
There should be a designated area for sampling of primary material provided that it is:
 Isolated and of controlled and monitored environment.
 Sampling should be done in a certain manner to avoid contamination and cross contamination and according to a documented procedure.
 There should be a written cleaning procedure for cleaning of the sampling area effectively.
6- Rejected product area:
There should be a physical separation for defected products, rejected products, expired or recalled products so that it should be:
 Well controlled and prevent their use until a final decision is taken on their fate.
 It should be clearly labeled.
 Locked and restricted only to authorized personnel.

B- Instruments:
 Equipment available in the storage area should only be used for its intended purpose only and to be used only in those licensed activities compliant with its license issued by Drug Control dept.
 All equipment should be calibrated and validated periodically including temperature monitoring devices, humidity monitoring devices and scales.
 Vehicles and equipment used to distribute, store, or handle concerned materials and products should be properly designed and equipped to insure protection from different environmental and weather conditions that it is operating in. proper policies and written procedures should be in hand to insure the above objective.
 The design and use of vehicles and equipment must aim to minimize the risk of errors and permit effective cleaning and/or maintenance, in order to avoid contamination, build-up of dust or dirt and/or any adverse effect on the quality of pharmaceutical products being distributed. To make available clear and detailed written procedures and documenting records for the cleaning methods with specified frequency for each vehicle in use.
 The use of any vehicle other than of those designated should be avoided under any circumstance, and in case this has to happen there should be a written standard procedure for the vehicle’s cleaning instructions along with other instructions that specifies the acceptable type of items or materials that could be transported within the same vehicle. In this regard it is reminded that this choice is not recommended and should be kept only for unavoidable and limited cases.
 The use of vehicles with defects that could affect the quality of the product or transferred materials should be avoided. Defected vehicle if any should be fixed while being clearly labeled with its condition until defect removal is accomplished.
 Written standard procedures should be made available for operating and maintenance of transporting vehicles clarifying the frequency of each maintenance measure. Records signed by a qualified party contracted for maintenance should be made available and used to provide maintenance history evidence of the concerned vehicle.
 Special protective precautions should be followed for transporting products or materials which not provided with any protective packaging.
 Storage conditions (e.g. temperature and/or relative humidity) required for maintaining the quality of transported products or material ( as mentioned on their label) should be provided, checked, monitored and recorded. All monitoring records should be kept and made available for review at any time. Recorded

monitoring data should be reviewed on receipt of pharmaceutical products to assess whether required storage conditions have been met.
 Vehicles and containers should be of sufficient capacity to allow orderly storage of the various categories of pharmaceutical products during transportation.
 Where possible mechanisms should be available to allow for the segregation during transit of rejected, recalled and returned pharmaceutical products as well as suspected to be counterfeits.
 Effective measures should be in place to prevent unauthorized persons from entering and/or tampering with vehicles and/or equipment, as well as to prevent the theft or misappropriation thereof.

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