SOP For Product Recall system is described in this post which you can follow in the section of the Quality Assurance Department.

OBECTIVE

This procedure is established to provide system for prompt and effective recall of product known or suspected to be defective and that may represent a health hazard to the consumer/user. 

SCOPE 

This procedure is applicable to Production and QA Department 

RESPONSIBILITY

Production Manager

Quality Control Manager

ACCOUNTABILITY

Manager Quality Assurance 

PROCEDURE 

The product recall is to be initiated by the Q.A. department.

Before initiating Product Recall, the Quality Assurance Manager shall critically check the following:

Evaluation of B.M.R, Analytical records Retained sample evaluation, Stability studies record (if applicable) and All other associated records.

After the approval of product recall by the product recall committee, Quality Assurance Manager shall issue the Product Recall Notification to the Warehouse (FG Store) and Sales Departments.  

It is important that before or upon initiating a recall, the company immediately on becoming aware of the problem, notify the MOH about the product recall.

If the notification fails and there is urgent need to recall the product, then the Sales Department may proceed the process. 

The Head of the Recall Committee should only contact government agencies. When reporting a recall to a government agency, be sure to record the date and time of the call and the name of the government employee taking the call.

Distribution record is checked by the Warehouse (FG Store) and Sales Departments and information is sent to concerned distributors and stockiest asking them to stop further sales and withdraw the batch from the retailers and send back to the factory warehouse.

Information is sent via recall letter.  A recall letter should Be: on the company letterhead dated and have a prominent heading that states “URGENT RECALL”, signed by the Head of Product Recall Committee (or a senior member of the company management)

The recall letter and form should be faxed or sent in a distinctive envelope, which has printed on it, in bold red print on the top left hand corner, the wording:

“MEDICINE RECALL OR ACTION IMMEDIATELY”

Recall communication should convey:

  • That the product in question is subject to recall 
  • That further distribution or use of any remaining product should cease immediately 
  • The instructions on what to do with the product

IMPLEMENTATION OF RECALL COMMUNICATION

Communication is so critical in a recall situation that the members of the Recall committee may need to devote nearly full time to the emergency in its earliest stages.

The following may be used in a recall communication:

  • Telephone (national & international) 
  • Public media (national & international)
  • Special delivery (national & international)

Conspicuous marking e.g. “MEDICINE RECALL or ACTION IMMEDIATELY” in bold red on the letter and envelope, and also “URGENT” for serious cases. (national & international)

A 24-hr hotline number may need to be implemented to answer any question from consumer.

A public warning is given through print media against the prescription, sale and usage of the defective   batch of the product.

The type of public warning should be specified in the recall strategy for the product e.g.

General public warning in the general media as appropriate 

A public warning through specialized news media such as professionals or to specific segments of the population like physicians, hospitals etc. 

Warehouse (FG Store) receives the recalled products from the distributors / market, counts the goods and updates the product recall ledger, and informs the QA Department for further action

QAM prepares product recall checklist according to the information received.

Goods received back from the trade in response to recall are isolated from normal stock, stored in a specific allotted space where it is labeled as “Recalled Goods”.

Effectiveness checks are made by FGWH, Marketing Department and Quality Assurance Department to ensure that product to be recalled has indeed been removed from the market including overseas market.

Q.A. and Marketing Department will work closely with the ministry of health during and after the recall.

Q.A. collects the samples from the recalled product batch for evaluation. QC/QA evaluates the sample   critically to determine the cause of the defect.

After determination of the root cause, the course of action to be taken is determined, which may be destruction (by Warehouse Department under the supervision of Quality Assurance Inspector)

Product recall assessment form is submitted by QAM to the Head of committee.

After evaluation and determining the action, QA submits the detailed report to the Plant Manager for approval, who has the authority to approve or disapprove the determined action.

Plant Manager sends the report back to QA with his remarks. QA forwards the approved report to the concerned department head for action. 

QA monitors the action to ensure that actions being taken by the concerned department fulfill the requirements determined and approved.

Complete documentation and record is maintained in the QA and Warehouse (FG Store) Departments.