Procedure For Product Recall

Procedure For Product Recall

         OBJECTIVE

• To lay down the Procedure for product recall.

• SCOPE
  • This Procedure is applicable for Handling of Product Recalls at Pharmaceutical Company.
• RESPONSIBILITY
  • It is a Joint responsibility of the Marketing Department in coordination with Quality Assurance
  • Head-Export / Company Appointed Business agent of the country in coordination with Quality Assurance.
  • Manager – Quality Assurance
• ACCOUNTABILITY
  • Manager-QA
  • VP-Plant & Operations.
• PROCEDURE
  • Information regarding products that may be deemed unfit for their intended purpose, may be received from.
    • Medical representative.
    • Medical practitioner
    • Pharmacist
    • The Consumer
    • Regulatory Authority/National Health Authority/Competent Authority of Country
    • Any other person or body as applicable.
  • Information on defect products are usually received by.
    • Medical representatives.
    • Medical advisors.
    • Marketing department but may also received by other employees.
    • Head-Export / Company Appointed Business Agent (in-case of export).
  • The person receiving information regarding a defect product shall endeavor to obtain the following information from the informant.
    • Name, address and telephone number of the complainant.
    • Name, batch number and expiry date of the defect product.
    • Details regarding the nature of the defects and whether any adverse effects have occurred that may be attributable to the defects.
    • Obtain an estimation of the quantity of product within the distribution chain on the basis of product dispatched from the company and the known sales experience. Sample of defected batch(s) of the product
  • On receipt of information regarding a product defect, Manager- Production / Manager Sales / Company appointed Business agent/ Head-Export (in-case of export) shall pass the information without delay, to Manager – Quality Assurance.
  • One receipt of the information shall determined by Manager of sales and or Manager – QA whether the defect is:
    • Minor – Unlikely to have an adverse effect on the consumer.
    • Major – is likely to have an adverse effect on the consumer, but not considered serious
    • Critical – is likely to give rise to a serious adverse effect, or may lead to death, of the consumer
  • The Manager of Sales / QA
    • Shall contact the complainant directly to verify the nature of the product defect.
    • Shall intimate competent sanitary authority of the country (Drug regulatory authority, Marketing authorization authority, Health Ministry).
    • Shall request for additional information, as applicable, from the Head-Export/ Company appointed Business agent (in-case of export).
  • The Manager-QA shall obtain total distribution record of batch(s) from the distribution/export department.
    • Examine the retained sample for signs of defect.
    • With the assistance of the Logistics and Marketing Department, identify Customers who have received product from the batch in question.
    • Place an immediate hold on further distribution of the batch(s) of the deemed defective product.
  • On receipt of information regarding a defect product, the Manager-Quality Assurance shall immediately call a meeting of the recall committee and present as full details as are available relating to the defect product.
  • A recall committee shall be set up, consisting of:
    • Director
    • VP-Plant & Operations.
    • Manager – Quality Assurance
    • Manager-Sales.
    • Manager – Quality Control
    • Manager-Process Development
    • Manager-Production.
    • Manager Logistics / Marketing/Company appointed business agent.
    • Head-Export/Company appointed Businesses agent as communicators (in-case of export).
    • Other as considered appropriate.
  • A time table shall be established for obtaining further necessary information regarding the defect product identifying the person(s) responsible for obtaining such information. A report of all findings shall be presented to the committee within a specified time.  In any event, the committee shall be informed about findings on a daily basis.
  • Manager-QA shall initiate for Health Hazard Evaluation of defected product. According the following shall be discussed with recall committee.
    • Whether any disease or injuries have already occurred from the use of the product.
    • Whether any existing conditions could contribute to a clinical situation that could expose humans to a health hazard. Any conclusion shall be supported as completely as possible by appropriate documentation and / or statements that the conclusion is the opinion of the individual making the evaluation.
    • Assess the hazard with respect to different segments of the population i.e. infants, children, elderly, surgical cases etc., with particular attention to those at greatest risk.
    • Assess the degree of seriousness of the health hazard to which the population would be exposed.
    • Assess the consequences (immediate or long term) of the occurrence of the hazard
  • Manager-Sales and Manager-Quality Assurance on the basis of Health Hazard Evaluation shall decide the recall level.
  • RECALL LEVEL.
    • Where the defect product is deemed to present a critical health or safety risk, a full recall shall be initiated. This will involve contact with wholesalers / distributors, pharmacists and Medical Practitioners and possibly the Consumer. A public announcement (newspaper, radio, TV) may also be required.
    • Where the defect product is deemed to present a major health or safety risk, a recall shall be initiated involving contact with wholesale dealers / distributors, and possibly pharmacist.
    • Where the defect product is deemed to present a minor health or safety risk, a recall shall be initiated involving contact with wholesale dealers / distributors, and possibly pharmacist.
    • Where the defect product is deemed not to present a health or safety risk further distribution of the defect product (batches) may be discontinued, with no further recall action.
  • The Manager – Quality Assurance   shall act as chairman and co-coordinator of all Recall activities.
  • The recall committee shall, based on the recall level, inform immediately to:
    • The National Health Authority or competent agency of the country regarding the nature of the defect and decision to recall.
    • Distribution in charge to arrange the necessary follow up actions so as to affect the product recall.
    • To competent sanitary authority of the country (in-case of export).
    • To the country manager / company appointed business agent of the Country    (in-case of export) for effective coordination during product Recall.
  • The recall committee shall inform to wholesale dealers / distributors, Pharmacist and Medical practitioner about the decision to recall, /Email/ Telephone / News paper /early telegram and / or personal visit by the Medical Representatives.
  • Defected product must be recovered from the wholesaler / distributors and Pharmacists as possible either by personal collections, mail or other appropriate means.
  • Reconcile the recovered   product against the quantity dispatched, and estimate the remaining quantity in the distribution chain.
  • Place all recovered product in a secured place until the recall is completed and an order made for the destruction of the product.
  • Prepare and submit a report on the progress of all the recall initially on a daily basis (first 2 weeks) then weekly thereafter, until such time as the recovery is complete, or no future recovery is likely or practical.
  • All recalled product shall be stored in segregated place and affix the status label “MARKET RECALLED PRODUCT” .
  • All defected recalled product shall be destroyed and documented.
  • Manager-Quality Assurance shall conduct a investigation into the cause(s) of the defect product and submit to the VP-Plant & Operations.
  • Product recall in Documentation.
    • Detailed in Format.
  • The effectiveness of activities related to recall must be periodically evaluated.
  • Special procedure in case of export special instructions are practiced during product recall incase of export.

Note: The plan, strategy and action shall be the same as described above in addition the following:

• Intimation of the defected product shall be made to the competent sanitary authority (Drug regulatory authority, Marketing authorization Authority, Health ministry) of the country.
• Head-Export / company appointed business agent shall be intimated for coordinating with all recall activities.
• Head-Export / company appointed business agent shall obtain the details of defected product, including sample and intimate to Head medical and Manager-Quality assurance.
• The decision of recall level and the possible health hazard evaluation shall be intimated to the Head-Export / Company appointed Business agent.
• Head-Export / Company appointed Business agent shall Co-ordinate for interacting with the competent sanitary authority of the Country for all product recall activities.
• Information of the quantity of Batch (s) lying in the distribution chain shall be collected by Country Manager/ Company appointed Business Agent for making effective product recall.
• Head-Export/ Company appointed Business agent shall appoint Immediate responsible persons (if required) for the effective product Recall by personnel collection from the retailer, Pharmacist, body or the consumer.
• Head-Export / Company appointed Business agent shall ensure the storage conditions of all recalled product in safe places, separate area till they wait for a decision about their destination.
• Head-Export / Company appointed Business agent shall effectively publish the product recall information by using the effective communication, media within the country (Internet, TV, Fax or public notice as such) in consultation with Manager-Quality Assurance.
• Head-Export / Company appointed Business agent shall be responsible for the day-to-day reporting of product recall activities and also for the conclusion statement of quantity recalled.
• After the completion of product recall operations, copy of conclusion report shall be send to the competent sanitary authority of the Country. Head-Export / Company appointed Business agent to appraise the situation as required.
• Similarly, a copy of investigation report made by Manager-Quality Assurance giving the possible cause for the defect, shall be intimated to the competent sanitary authority (Drug regulatory authority, Marketing authorization authority, Health ministry) of country.
• Head-Export/ Company appointed Business agent is also responsible for needful documentation during the product recall operations.

• ABBREVIATIONS

6.1     SOP       –   Standard Operating Procedure

6.2     QA        –    Quality Assurance

• FORMAT
  

8.0    DISTRIBUTION LIST

ATTACHMENT – I

PRODUCT RECALL REPORT 

PHASE –I: INFORMATION OF THE DEFECT PRODUCT

1. Product defect information received from:  Medical practitioner  

                                                                                 Pharmacist      

                                                                                 Hospital /Body

                                                                                 National Health Authority

                                                                                 Consumer        

                                                                                 Others

                                            Specify :     _______________

Address      :

Phone No. :

Mail ID :

Fax No       :

2. Product defect information received by:     Medical representative  

                                                                                 Marketing Department

Country Manager      

Company appointed Business Agent

                                                                                 Others

                                                                                Specify : _______________

Address      :

Phone No. :

Mail ID :

Fax No        :

Product defect information received on:

Product defect information Communicated to/on: Manager –QA

Head-Medical

Date: _______________

Product defect information details:

Nature of Defect: _______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

Product Distribution details

Quantity distributed on:

Distribution chain Address:

(Attach all messages/ communication / other relevant report)

ATTACHMENT -II

PRODUCT RECALL CONCLUSION REPORT 

1. Manufacturer Name & Address: _____________________________

Corporate Office:                                                      Manufacturing Facility: 

Defect product information

Product            :

Batch No(s).    :

Packing details:

Health hazard evaluation: ________________________________________________________________________________

Recall level: ________________________________________________________________________________

Recall initiated on:

Recall Completed on:

Recalled product reconciliation:

Recalled product disposition: ________________________________________________________________________________

Action plan for future: ________________________________________________________________________________

Sign/Date: ____________________                           Sign/Date: _______________________

(Head-Medical)                                                                      (Manager-Quality Assurance)

Product recall conclusion authorized by/on: _______________________________

VP-Plant & Operations

Cc to:  National Health Authority /Competent sanitary authority of the country (Drug regulatory authority, Marketing authorization authority, Health ministry), Head-Export & Company appointed Business agent).

ATTACHMENT – III

STANDARD PRODUCT RECALL LETTER

To:

Dear Colleague

It has come to our notice (Product Name):

Having batch number(s):

Has shown

________________________________________________________________________________

Please refrain from dispensing any of this batch number and return all your stock of this batch number to our office at:

________________________________________________________________________________

All returned stock or this batch number will be replaced on free of cost.

_______________________________________________________________________________

Please coordinate with Mr. ____________________________________ (Head-Export /Company appointed Business agent/Manager-Marketing/Manager-Quality Assurance) for all practical purpose.

We apologies for any inconvenience caused to you and thank you for your co-operation

_______________________________________________________________________________

Yours faithfully,________________________________

VP-Plant & Operations 

PHASE –II: DEFECT ANALYSIS

Category of Defect :

Critical               Major              Minor

Defect sample received : Yes                  No

Defect sample inspection details:

Immediate hold on distribution of batch (s): Yes No

Communication to/on*:                                                              Date

Head-Export                          ____________

Business agent                     ____________

Other agent

(Specify): __________________________

______________ ____________

(* Attach communication letter)

Competent Sanitary Authority intimation to/on * : Yes       No                 Date :_________

(* attach Communication letter)

Recall committee meeting on:

Members Present      :           Director

Head-Export

Manager-Quality Assurance

Head-Medical

Manager-Quality Control

Manager-Production

Head-Export

Company Appointed Business agent

Manager-Marketing

Others:

(Specify):____________________

Health hazard evaluation*:

(Head-Medical)

(*Attach supporting literature)

Evaluated By:

PHASE –III : RECALL PLAN AND STRATEGY

Recall level

Very critical health / safety risk –           Complete recall from wholesaler / distributor/

pharmacist / medical practitioner / Consumer.

Major health/safety risk – Recall from wholesaler/ retailer/pharmacist/           medical practitioner.

Minor health/safety risk               –           Recall from wholesaler/ retailer/pharmacist.

No advise health/safety risk – No further distribution / no recall plan.

Recall plan and schedule

PHASE-IV : PRODUCT RECALL CONTROL AND RECONCILIATION

Sign/Date : ___________________                                        Sign/Date : ______________________

(Manager-Marketing )                                                      VP-Plant & Operations

PHASE-V: RECALLED PRODUCT DISPOSITION

Disposition status – Rejected, destroyed at factory

Rejected, destroyed at other than factory

Specify: _______________________________

Destruction mode                 :

Destruction by/on                 :  ________________

Destruction witnessed by/on :  ________________               ____________

(Quality Assurance)            (Warehouse)                              (Head-Export

/Company appointed Business agent in case of export)

Destruction authorized and confirmed by / on:   ________________________

VP-Plant & Operations

                                               ATTACHMENT – IV

PRODUCT RECALL WITHDRAWAL PROCEDURES

Press statement:

________________________________________________________________________________

Issued by:       _________________

Date:              _________________

Time:               _________________

Laboratories a pharmaceutical company wishes to advice that a single batch / batches bearing batch

Number ____________________of product _________________________ has shown

User/whoever possessing of this particular batch number are kindly requested to discontinue its use and return the same (if possible) to the local dealer or to our office branch nearer to your place

________________________________________________________________________________

Contact person (s):            Address   : _________________         Address   : ________________

Phone No.: ________________           Phone No.: ________________

E.Mail Id. : ________________             E.Mail Id. : ________________

Fax No    : ________________             Fax No     : ________________

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