Monday, June 22, 2009

Concerned establishments and Scope,pharmaceutica store

A) Establishments concerned
Any pharmaceutical or health establishment which deals in handling, storing or distributing pharmaceutical or healthcare products has to be concerned by the guidelines and instructions mentioned in this issue. These establishments could be:
 Medical stores.
 Stores as part of pharmaceutical and medical devices manufacturing establishments.
 Nutrition & Health Dietary Supplements food stores.
 Herbal pharmaceutical stores.
 Private pharmacies and hospital pharmacies.
 Stores designated for storing pharmaceuticals and medical products at health establishments like hospitals and Public Healthcare institutions.
B) Management and Personnel:
1- There should be an adequate organizational structure defined with the aid of an organizational chart. The responsibility, authority and interrelationships of all personnel should be clearly defined and documented through clear job descriptions.
2- At each storage site (e.g. that of a manufacturer, distributor, wholesaler, and community or hospital pharmacy) there should be an adequate number of qualified personnel available at all working hours to achieve pharmaceutical quality assurance objectives.
3- A designated person should be appointed at each distribution point who should have defined authority and responsibility for ensuring that a quality management system is implemented and maintained. This person should be qualified according to the set requirements mentioned in the relevant administrative decision (circular).
4- All personnel (pharmacists and others) in the storage area should be provided by proper initial and continuous training related to the Good Distribution and Storage Practice, related rules and regulations, and safety regulations, in addition to be capable of meeting these requirements. The training records should be kept for review if needed.

5- All members of staff should be trained in, and observe high levels of, personal hygiene and sanitation. Clear instructions for personal Hygiene should be distributed and observed.
6- Personnel employed in storage areas should wear suitable protective or working garments appropriate for the activities they perform.
7- First-aid procedures and equipment for dealing with emergencies involving personnel should be available.
8- There should be arrangements in place to ensure that management and personnel are not subject to commercial, financial and other pressures or conflicts of interest that may have an adverse effect on the quality of service provided.
9- Codes of practice and disciplinary procedures should be in place to prevent and address situations where persons involved in the distribution of pharmaceutical products are suspected of, or found to be implicated in, the misappropriation and/or theft thereof.
B- Contracting with third party:
1- Contracting (outsourcing) of certain storing or distribution services or activities is acceptable, given that these are outsourced from qualified and legitimate parties.
2- Any activity relating to the distribution of a pharmaceutical product which is delegated to another person or entity should be performed in terms of a written contract which is agreed upon by the contract giver and the contract accepter. The contract should define the responsibilities of each party including observance of the principles of GS &DP.

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