Monday, June 22, 2009

Instructions for receiving supplied materials or products

1- On receipt each incoming consignment and their invoices should be checked to match against the relevant purchase order made by the establishment in regard with all specifications (quantities, batch numbers etc.). Each container should be physically verified to ensure its compliance with all legal and regulations given as label description, expiry date , batch numbers quantities , etc…) 2- Each container received should be carefully inspected for uniformity of containers, any clear defects, for possible, tampering and damage. In case of any suspect containers or, if necessary, the entire delivery should be quarantined for further investigation. 3- Received Items or goods should be subdivided according to brand, the supplier’s batch number should the delivery comprise more than one batch in all the storage areas (Quarantine and final storage area). 4- In warehouses where samples of the received goods should be drawn (Manufacturing sites warehouses and similar establishments), the sampling should be carried out by competent and trained personnel. 5- Received consignments should be kept at the quarantine area until ensuring its compliance with all technical specifications required based on either quality control lab reports, an authorized official legal release or rejection is obtained. 6-Effective measures should be in place to ensure that rejected; defected or expired materials and pharmaceutical products cannot be used or bypassed. They should be stored separately from other materials and pharmaceutical products while awaiting their disposal either by destruction or return to the supplier. 2- Stock Rotation and control.
1- Periodic stock reconciliation should be performed by comparing the actual and recorded stocks.
2- All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue.

3- In case of partly used containers , should be securely re-closed and resealed to prevent spoilage and/or contamination during subsequent storage. Care should be taken to use first Containers which have been opened or partly used before those in unopened containers.
4- Damaged containers should not be issued unless the quality of the material has been shown to be unaffected.
5- Regular checks should be carried out for all stocks to identify and remove obsolete and outdated materials or products.
3- Stock Dispatch procedures and instructions:
1- The concerned management should establish and endorse written standardized procedures for dispatching and handling of stock taking into account the nature of the materials and products for any special precautions might be required.
2- Care should be taken on selling or distributing pharmaceutical products only to parties or entities that are legally licensed and entitled to acquire such products. Written proof of such entitlement must be obtained prior to the dispatch of products to any party.
3- Measures should be taken to only dispatch those batches of a valid quality certificate available. This certificate based on approved quality control testing should ensure the compliance of the batch with pre-set specifications according to recognized scientific references. If such a proof doesn’t exist or the batch is out of specifications then the establishment should refrain from its selling or distribution. In such a case the establishment should transfer all quantities of that batch to quarantine and apply the quarantined stock procedures in hand.
4- The establishment should refrain from selling, distribution or dealing with any material or product after their expiry date or so close to the expiry date that this date is likely to occur before the products are used by the receiving party.
5- The dispatch of pharmaceutical products should be commenced only after the receipt of a valid and documented delivery order.
6- Records for the dispatch of material and products should be prepared and should include at least the following information:
 date of dispatch
 name, address and status of the intermediate (if applicable) and final receiver (e.g. retail pharmacy, hospital, community clinic)
 A description of the products including, e.g. brand name, INN name, dosage form, strength (if applicable), packing and presentation of pack units size of pack unit and number of units per pack.
 Quantity of the products, i.e. number of containers and quantity and size per container.
 assigned batch number and expiry date or retest date for starting materials
 required transport and storage conditions
 Unique serial number to allow identification and traceability of the delivery order.

7- Records of dispatch should contain enough information to enable traceability of the pharmaceutical product from the point of its dispatch by the manufacturer until reach of the final user. Such records should facilitate the recall of a batch of a product from markets or users if necessary. The records and documents of the received and dispatched consignments should be available and kept in a way that enables its quick review on need or on the request of relevant official authorities.
8- Each party involved in the distribution chain has a responsibility to ensure traceability for dispatched materials or products.
9- Transportation and delivery of consignments to the receiving party should only be carried out only after taking in and checking receiving orders to be matched against dispatch orders which should be kept as part of documentation.
10- The dispatching party should ensure that the receiving party owns the required resources and is capable of storing the received consignment in a manner that preserves its quality. Delivered quantities should be proportionate to the storage area size provided by the receiving party.
1. Materials and pharmaceutical products should be transported in such a manner that doesn’t allow:
 The loss of their identity.
 Its contamination by weather, surrounding environment r by other products.
 Its spillage, breakage or spoilage.
 Misappropriation and theft.
 Exceeding of appropriate temperature and relative humidity conditions in the case of pharmaceutical products, as appropriate which could negatively affect the quality.
2. Packaging materials and transportation containers should be of certain specifications and organized throughout shipping process in manner which provides protection for the shipped goods from external factors and prevent damage of pharmaceutical products during transport.
3. To ensure communicating all relevant conditions and precautions for storage and transportation to the entity(-ies) responsible for the transportation of pharmaceutical products.
4. Transportation for material and pharmaceutical products should be carried carefully in a manner that corresponds to the special storage precautions for each product’s nature:
 Care should be given for products that require special precautions such as radioactive, flammable or internationally controlled substances. Security and safety should be provided through validated procedures.

 In case of shipping rejected, counterfeit or expired products, transported items should be clearly labeled to how its status and should be secured against tampering or theft.
5. transported consignment components should be labeled and documented with their storage requirements to be followed during transportation.
6. Proper and identifying documents should be accompanied during transportation available for review by authorities or similar entities.
7. The transporting vehicle or containers should be effectively cleaned according to the approved and validated written standard operation procedures prior to its loading Extra care should be taken when designing delivery schedules, loading and unloading in order to prevent possible physical damage (Ex: to organize bigger containers and those to be delivered later in the back and so on).
8. Storage conditions as temperature degrees should be recorded periodically. Such records should be available for review on request.
9. Special care should be used when using dry ice in containers. It must be ensured that the pharmaceutical product does not come into contact with the dry ice, as it may have an adverse effect on the quality of the product due to freezing.
10. Any case of spoilage or breakage should be reported by a documented report to the receiving party and to the dispatching party. use it can effect the stability of some them due to freezing

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