Raheeg Medical

Our Quality Manual

Introduction:

• We have to work in a manner that satisfies the Pharmacy Act.

• Also we have to exert our utmost efforts to operate at a high level of quality assurance & adopt WHO Guidelines on Good Distribution and Storage Practice of Medicinal Products for Human Use.

• Self inspections should be conducted (and recorded) in order to monitor the implementation of and compliance with the WHO guidelines.

Our quality management system tries to ensure that:

• customer requirements and expectations are met.

• activities comply with regulatory requirements.

• storage conditions are observed.

• contamination by other products is avoided.

• adequate turnover takes place.

• the right products are delivered, on time.

• there is an effective recall procedure.

Suppliers:

• We have to obtain products only from authorised suppliers .

• We import only from reliable suppliers who had been inspected by our local authorities. The inspection visit from our authorities aims at ensuring pharmaceutical quality objectives by observing Good Manufacturing Practice-GMP- of all our suppliers. This policy ensures that products released for distribution in our country are of the appropriate quality.

• We abide by the regulatory authority laws to ensure that this level of quality should be maintained throughout the distribution network so that authorized medicinal products are distributed to retail pharmacists and other persons entitled to sell medicinal products to the general public without any alteration of their properties.

• Receipt and checking of deliveries by sales department.

Storage

• Medicinal products should normally be stored apart from other goods and under the conditions specified by the manufacturer in order to avoid any deterioration by light, moisture or temperature.

• Temperature should be monitored and recorded. Records of temperature should be reviewed regularly. Our Warehouse degree of temperature is controlled by a sufficient number of air conditions.

• The storage facilities should be clean and free from litter, dust and pests (animal & insects)

• There should be a system to ensure stock rotation (‘first in first out’) with regular and frequent checks that the system is operating correctly.

• Products beyond their expiry date or shelf- life should be separated from usable stock .

• Medicinal products with broken seals, damaged packaging or suspected of possible contamination should be withdrawn from saleable stock, and if not immediately destroyed, they should be kept in a clearly separated area so that they cannot be sold in error or contaminate other goods.

Documentation

• All documentation should be made available on request of competent authorities.

• Records should be kept of each purchase and sale, showing the date of purchase or supply, name of the medicinal product and quantity supplied and the name and address of the supplier or consignee.

• Records should ensure the traceability of the origin and destination of the products, e.g. by use of batch numbers, so that all the suppliers of, or those supplied with a product can be identified

Distribution

• All our distribution vans are equipped with air-conditioning.

• Deliveries should be made only to other authorized wholesalers or to persons authorized to supply medicinal products.

• Permit the Licensing Authority to carry out inspections.

• Retain documents necessary to facilitate product recall or withdrawal

• Medicinal products should be transported in such a way that:

1. Their identification is not lost.

2. They do not contaminate and are not contaminated by, other products or materials.

3. Adequate precautions are taken against spillage, breakage or theft.

4. They are secure and not subjected to unacceptable degrees of heat, cold, light, moisture or other adverse influence, or to attack by micro-organisms or pests.

5. Medicinal products requiring controlled temperature storage should also be transported by appropriately specialised means.

Personnel

• Our technical department, to be headed by a pharmacist, controls all the issues related to registration of products, good storage conditions and distribution. He has defined authority and responsibility for ensuring that a quality system is implemented and maintained.

• The technical manager has to provide information as requested by the Licensing Authority

• Should also inform the licensing Authority of any proposed structural alterations or discontinuance of use of licensed premises.

• Our key personnel involved in the warehousing of medicinal products should have the appropriate ability and experience to guarantee that the products or materials are properly stored and handled.

• Personnel should be trained in relation to the duties assigned to them and the training sessions recorded.

Raheeg's Organigram.