Monday, June 22, 2009

Complaints handling and product recall

1- Complaints handling:
1- The establishment’s management should be put in a place a written procedure for the handling of complaints which clarify procedures to be followed for information collection, investigating facts and follow up corrective actions. A distinction should be made between complaints about a product or its packaging and those relating to distribution.
2- In the case of a complaint about the quality of a product or its packaging the original manufacturer and/or marketing authorization holder should be informed as soon as possible and not wait until full investigation is performed.
3- Any received complaint, investigation carried out and their results should be documented.
4- To consider the possibility of recurrence of the same defect at other batches for the same when investigating any quality complaint.
5- There should be a written documented procedure in place for procedures to be followed in case of possible investigation results reached and actions to be taken through classifying type of results according to level of hazards that could be caused.
2-Recalled products:
1- Recalled products for quality reasons should be handled according to approved and documented procedures.
2- A qualified person should be appointed to be in charge of recall or pull out procedures.
3- Set procedures and arrangements should guarantee prompt and effective actions in case that a suspected quality defect which requires recall and suspension of batch/es is proven to be true.
4- All records that document the followed procedures, taken actions and recalled quantities with the required data should be readily available. These records should contain sufficient information on pharmaceutical products recalled (brand name, INN name, strength, batch number, entities that product was recalled from )signed by persons in charge for each entity involved.
5- All recalled pharmaceutical products and materials should be kept in quarantine area, and care should be given not to be restored with the stock approved for sale. Its release and reselling could be done only after being approved by a qualified person in charged based on proper evaluation and quality control testing. In case a quality defect is proven the recalled stock should be labeled as rejected and segregated in the rejected items area.

6- Any disposal for any rejected items by any means (destruction or re-export, etc..) should be done only after taking the permission of Drug Control Department at MOH. This requires submitting a documented proves and relevant certificates including the quantities, specifications of the concerned rejected goods signed by persons which approved the rejection.
3- Goods’ Return from distribution points:
1- In case that any quantity of products or materials were returned for reasons related to any quality defect and it was proven that this defect is related to the quality of the products or its packaging then the case should be dealt with as mentioned in the second paragraph of the current chapter.
2- In case that any quantity of a product or materials were returned for a reason related to distribution operations, a full investigation should be carried out. If the investigations realized that returned goods are considered not suitable for reissue or reuse, the second paragraph of the current chapter should be applicable.
3- In case products are returned for pure commercial reason of no relation to the product’s quality the following instructions should be followed:
a- All returned products or materials should be kept in quarantine area. Its release and reselling could be done only after being approved by a qualified person in charged based on proper evaluation and quality control testing.
b- Any reissued stock should be labeled and to add its data within stock records.
c- Any products directly returned by patients (end users) through retail pharmacies should not be reissued to be stored with the approved for sale stock. Such products should be kept within rejected items area ready for disposal.
4- Handling of counterfeit products 1- Any counterfeit or suspected counterfeit medicines found in the pharmaceutical supply chain should be confiscated and segregated immediately in the rejected items area from other pharmaceutical products and recorded. Such products should be clearly labeled in order to prevent further distribution or sale. All confiscated quantities should be secured in a manner that prevents misappropriation and theft, were these items will be considered as a responsibility of the designated person in charge, this requires his signing for all relevant data records.
2- The holder of the marketing authorization, relevant official authorities and Drug Control Department, should be informed immediately. A full detailed report of the case in hand, attached with photos for the inner and outside packaging and the dosage form

unit along with representative samples should be submitted to be checked and analyzed by the Drug control Dept. 3- Upon confirmation of the product being counterfeit a formal decision should be taken on the disposal of counterfeit pharmaceutical products and the decision recorded under the supervision and control of the relevant authorities.

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