Standard Operating Procedure of Product Recall in Pharmaceuticals Plant is describe in this post.
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1. Purpose:
1.1. This procedure provides a system for prompt voluntary product recall in accordance with a predetermined plan.
2. Scope:
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. Responsibilities:
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. Procedure:
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:
|
ACTIVITY |
RESPONSIBILITY |
|
Director
(Technical) will immediately inform and issue a notice to all concerned
regarding product recall. |
Director
(Technical) |
|
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. |
Director
(Technical)/ Manager
Marketing |
|
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 |
Director
(Technical) |
|
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 |
Director
(Technical) (to be assisted by the QC Manager, Production Manager Inv.
Control Manager & Admin Manager |
|
Check and
record quantity in stock. Immediately stop further distribution. |
Inventory
Control Manager/Admin Manager |
|
Determine
the names and addresses of consignees from Finished Goods Distribution Record
(including that which may be in transit and inform Director Marketing). |
Inventory
Control Manager/Admin Manager |
|
Inform
Consignees by telephone/fax/courier delivered letter/Email/Whatsapp. Advised
to collect & return defective stocks. |
Director
Marketing /Admin Manager |
|
Segregate
and store the defective product identified by red color labels giving: Name
and strength, reported defect, Batch Number, and date received back. |
Inventory
Control Manager |
|
Review of
nonconformance & disposal Instructions |
Director
(Technical) |
|
Ensure
Disposal Instructions are implemented |
Director
(Technical) |
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