Saturday, 16 March 2013

Standard Operating Procedure – Drug Distributor: Handling a Product Recall

(Header as exampled by FDA)


Objective:
  • To ensure that the drugs being distributed by the supplier is safe and effective.
  • To have a team that will monitor and recall the products in case FDA requires a drug to be recalled from the market.

Scope:
  • All products in the market voluntarily recalled by pharmaceutical company or issued by FDA.

Responsibility:
  • Pharmacist

Procedure:
  • Upon receipt of a case report, the FDA Committee for product recall will assess the hazard presented through issuance of drug recall. Such case report may come from the responsible company (company volunteering), FDA technical divisions, DOH or other government offices, or consumer complaints.
  • The Committee will submit a written recommendation to the FDA director for the issuance of a recall order or to confirm a company initiated recall.
  • The concerned DOH offices will be informed of the decision to order product recall.
  • A Public Health Alert will be issued within twenty-four (24) hours for cases that have bee determined as Class 1 or Class II Recall.
  • If recall is not firm-initiated, a notification will be issued to the firm regarding the recall recommendation together with a request for the submission of recall plan/procedure and other information listed in Section 6.2.
  • An in-depth inspection of responsible establishment/production facilities where the violation occurred will be conducted by the concerned inspection division of FDA.
  • If necessary, other DOH units and government agencies will be utilized in implementation of the recall.
  • The concerned FDA inspection division will audit the recall operation by developing and implementing a recall audit program.
  • In case the concerned firm refused to conduct a product recall, regulatory action and/or other measures will be pursued by FDA.
  • The FDA will determine when the recall will be terminated and upon such determination, provide written notification of the termination of the recalling firm.

Quality of Records:
  • Pharmaceutical companies should decide and record all final actions taken on all recalled goods. It should also take care of all stored goods with proper instruction until the final action is not taken on the recalled goods.

Forms:
  • Batch Distribution Logbook

End of Document
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