Complaints%20and%20Recalls

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Complaints and Recalls
Prepared by Paras J Shah M.Pharm sem 1
Quality Assurance Guided by Dhaval
sir Smt.R.D.Gardi B.Pharmacy Collage Rajkot
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• Some complaints have attempted to increase the
  amt of feedback.Toll free no- positive
  suggestions forr impruvements.
• Evalution of pdt information on the potencial
  problem.
• Complain handling system
• step 1 Receiving complants
• step 2 Technical investigation
• step 3 corrective action and feed back to
  customers
• step 4 monthly report and trend analysis

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• Recall A firm removal or correction of marketed
  product that FDA considers to be in violation of
  laws it administers and against which agency
  would initiate legal action.

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Handling Of Returned Drug Reprocessing

• An examination of the reasons for return in order
  to decide whether further action is required on
  the lot or to the storage and distribution chain.
• If the goods are found in normal range of
  condition it will be redistribute after visual
  examination. Or if not found then return to stock
  as is or after reprocessing after appropriate
  evaluation.
• Maintain full comprehensive records to allow
  identification of returned good distribution and
  accountability in event of recall.
• To remove from commerce portions of a lot which
  may have been adversly affected.

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Recall Procedure

• Responsibility
• The general manager (the highest person in
  management) has the ultimate responsibility to
  direct the prompt of defective / recalled from
  market.
• Product recall management
• Procedure should settle a center to collect and
  store all returned stocks of the recalled
  product.
• All needed data quality and nature of product
  shall be noted down by this center as records.
• Fate of Product recall
• All records and information on the returned will
  be collected for evaluation purpose
• Thats report presented to the Product Recall
  committee and the fate of the product shall be
  determined.
• The final recall report
• Final recall report a written evaluation
  summarizing the circumstances leading to the
  recall, corrective action taken and the
  disposition of the recalled product by the recall
  team once the recall considered closed.

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Documentation

• Quality control department is responsible to keep
  in recall file.
• This files will retained for at least one year
  after the expiration date of the recall lot.
• Recall Completed
• For monitoring purpose, FDA classifies
  recall action completed when all outstanding
  product, which reasonably be expected is
  recovered or corrected.

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• Thank you