Product Recall SOP


Product Recall SOP


1.0   PURPOSE:

1.1.         This procedure provides a system for prompt voluntary product recall in accordance with a predetermined plan.

2.0    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.

3.0   RESPONSIBILITY:


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:


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:

SOP will be reviewed at least annually.





ACTIVITY
RESPONSIBILITY
RECORD
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 Record)
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
Store Records
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
Office files
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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