Product Recall SOP
1.0
PURPOSE:
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1.1. This procedure provides a system for
prompt voluntary product recall in accordance with a predetermined plan.
2.0 SCOPE:
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2.1. This procedure applies to all finished
products manufactured, packed, repacked, marketed & distributed by __________ Pharmaceuticals. If and when a Quality defect is reported/complained from
market.
3.0 RESPONSIBILITY:
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3.1. Marketing Director is
responsible to initially record and review customer complaints.
3.2. Director (Technical) will
further investigate the product complaint. He will recommend recall action when
considered necessary. He is to ensure that contacts for ___________
distributors mention the nature and purpose of the recall notice.
3.3. Director (Technical) is
responsible for initiating and co-coordinating all product recall activities.
3.4. Director (Technical) is
responsible to review, revise and maintain this procedure.
4.0 PROCEDURE:
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4.1. Recall
is a voluntary action by _____ Pharmaceuticals. and its distributors to
protect the public health and well being. Outline of Recall procedure is as
under:
4.1.1. Director
(Technical) will arrange a meeting of Head of Production, Quality, Stores and
other relevant persons and will inform about the complaint received from
internal finding or any other source.
4.1.2. Quality
Assurance Department will be responsible for the assessment of complaint and
identifies the non-compliance issue of the product
4.1.3. Recall
decision depends on the potential hazard of the defective product and the
extent of product distribution. Director (Technical) will inform to all
concerned health authorities by submitting recall notice.
4.1.4. An NCR
(F-07-009) is raised by QA manager/Director (Technical) as a result of complaint
requiring Product Recall.
4.1.5. Once a
complaint/NCR is investigated and the Director (Technical) with consultation of
Director Marketing has determined that recall of a batch/lot is necessary,
4.2. The
RECALL PLAN is mentioned below:
5.0
REVIEW FREQUENCY:
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SOP will be reviewed at least annually.
ACTIVITY
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RESPONSIBILITY
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RECORD
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Director (Technical) will immediately inform
and issue a notice to all concerned regarding product recall.
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Director
(Technical)
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Director (Technical) recommends recall action
to the Director Marketing who initiates product recall.
In case of Products Exported, Manager
International Marketing to initiate for destruction of Goods in the country
of export under supervision of authorized Agent.
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Director
(Technical)/
Manager
Marketing
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(Recall Action Record)
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Recall action by Director (Technical) and the following
personnel or their assistant are called to participate in the recall
activity:
Quality Control Manager
Production Manager
Inventory Control Manager
Quality Assurance Manager
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Director
(Technical)
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Ascertain and
verify identification of the products to be recalled. Include the following
information on F-07-011
Name of the product, its strength and pack size
Product Batch Number
The Nature of Defect
Total Quantity
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Director
(Technical) (to be assisted by the QC Manager, Production Manager Inv. Control
Manager & Admin Manager
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Check and record quantity in stock. Immediately
stop further distribution.
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Inventory
Control Manager/Admin Manager
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Store
Records
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Determine the names and addresses of consignees
from Finished Goods Distribution Record (including that which may be in
transit and inform Director Marketing).
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Inventory
Control Manager/Admin Manager
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Inform Consignees by telephone/fax/courier
delivered letter/Email/Whatsapp. Advised to collect & return defective
stocks.
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Director
Marketing /Admin Manager
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Office
files
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Segregate and store the defective product
identified by red color labels giving: Name and strength, reported defect,
Batch Number, and date received back.
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Inventory
Control Manager
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Review of nonconformance & disposal
Instructions
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Director (Technical)
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Ensure Disposal Instructions are implemented
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Director (Technical)
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