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Complaints

All complaints and other information concerning potentially defective products are carefully reviewed according to written procedures.

QP manager and marketing manager are responsible for handling the complaints (logging, classifying) and deciding the measures to be taken, together with sufficient supporting staff to assist them. There are written procedures describing the action to be taken, including the need to consider a recall, in the case of a complaint concerning a possible product defect.

Any complaint concerning a product defect (from responsible pharmacist of distributer, costumers, questionnaires which are filled by pharmacies or M.O.H inspectors) is recorded with all original details in a special form by marketing manager and thoroughly investigated in the corrective and preventive measure committee with participation of production manager, quality control manager, QA manager and anybody involved in production.

If product defect is discovered or suspected in a batch, consideration is given to whether other batches should be checked in order to determine whether they are also affected.

If necessary appropriate follow-up action, possibly including product recall, are taken after investigation and evaluation of the complaint. All the decisions and measures taken as a result of a complaint are recorded and referenced to the corresponding batch records. The conclusion of complaint through marketing manager is sent to complainant unit.

Complaints records are regularly reviewed by QP department for any indication of specific or recurring problems that require attention and might justify the recall of marketed products.