Asean GMP Recal Module

Project co-financed by European Union
Project co- financed by Asean
ASEAN GMP TRAINING MODULE
PRODUCT RECALL
Prepared by Heng Huot - Cambodia
Approved by ASEAN Cosmetic GMP Team Endorsed by ASEAN Cosmetic Committee
European Committee for Standardization Implementing Agency
Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-
CONTENT OF PRESENTATION
( Introduction Objective Scope ( General Descriptions ( Recall Procedure ( Related Hyperlink Documents ( References
INTRODUCTION
INTRODUCTION
This module is to assist the cosmetic manufacturer to establish a product recall system. Any activity related to product recall must be aligned to the Post Marketing Surveillance Guideline
OBJECTIVES

To identify the key issues of product known or suspected to be defective. To put in place a system, procedures and resources to institute product recall.
SCOPE
This system is applicable to the cosmetic manufacturer during the institutionalization of product recall .
GENERAL DESCRIPTION
DEFINITION (1)
Product recall : is a process taken by the responsible person who placed the product on the market, to remove or withdraw a particular cosmetic product from all links of distribution. The removal or withdrawal may be due to critical quality defects discovered or serious adverse cosmetics reactions reported which might cause health risks to users during and after distribution of the product
DEFINITION (2)

Safety Alert : Advice regarding a specific situation of a product, which is not conforming with the safety specification. When there is a risk of significant hazard to consumers of a product which has been distributed on the market ,the manufacturer should disseminate the safety alert through mass communication media available including newspaper, radio and television
DEFINITION (3)

Withdrawal: Removal of product from sale or use for reasons not connected with quality and safety such as change of packaging etc. as a marketing strategy Recall for Product Correction: the removal of product for rework.
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REASONS FOR RECALL

Voluntary recall : Customer complaint Detection of quality and safety failure after release Result from the ongoing stability testing Result of an inspection Tampering Adverse event reporting Mandatory recall : Directed by the national regulatory authorities
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RECALL PRINCIPLE
There should be a system to recall products known or suspected to be defective from the market promptly and effectively.
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BASIC REQUIREMENTS

Preferably, responsible person is independent from seller or marketing Must have an effective recall SOP in place. Distribution records should be readily available to responsible person. Secure storage of goods awaiting disposition. For mandatory recalls :
must notify all NRA and all countries to which product may have been distributed. Must liaise with NRA for all recall events .

If required, public warning/notices will be issued in order to alert the customers. Progress recorded and final report issued Reconciliation between delivered and recovered quantities.
Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 1413
CLASSES OF RECALL

Unless the relevant authorities have already specified the degree and level of a particular product recall, the class and level will be decided by the product recall committee based on the risks involved . The product recall committee shall comprise of personnel who are responsible for the execution and coordination of recall. The persons responsible should handle all aspects of the recalls with the appropriate class of urgency. In cases of product recall initiated by the manufacturer, the product recall committee must inform the relevant authorities immediately of this decision when necessary.
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RECALL CLASSIFICATION
NO CLASSIFICATION A Class I Recall SITUATION EMBARGO
Products with major health It should be under an embargo within 7 days risks Products with minor / It should be under an unlikely health risks or sub embargo within one standard month
Class II Recall
The class of product recall is classified according to the seriousness of quality defects and adverse events of the products.
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LEVEL OF RECALL
NO A B LEVEL OF RECALL Up to all consumers (end users) Up to all points of sales (e.g. pharmacies, beauty centers, beauty saloons, beauty outlets) Up to all sub distributors (wholesalers, grocers). Up to all importers and main distributors. The level of the product recall depends on : the nature of the problem, the extent of the product's distribution and, the degree of hazard involved.
C D
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NOTIFICATION OF RECALL
A sample of the recall notice must exist. Recall notices must be mailed in envelopes or faxed which can be clearly recognised as such. The notification of recall should include: The name of the product, and pack size The product batch number The nature of the defect The action to be taken The urgency of the action (with reasons, indication of health risk, as appropriate)
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RECALL NOTICES DISSEMINATION

LEVEL A : TO ALL CONSUMERS
This level of recall will apply to Class I recall and carried out in the comparatively rare instances when it is necessary to try to stop all use of a product and to recover stock that has reached the end user. When there is imminent danger the public are warned by a media release which is meant to urgently alert the public by radio, television and the press.
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LEVEL B : TO ALL POINTS OF SALES
This level of recall will apply to Class II recall. All wholesalers will be identified and asked to provide contacts by telephone to obtain a list of all points of sale. These points can be established through a distribution record. Recall notices will be mailed or faxed to all points of sales. At the same time representatives from the company will be sent to these points of sale to retrieve the stocks.
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LEVEL C : TO WHOLESALERS & STOCKISTS
This level of recall will apply to Class II recall where consumers are not at any risk from administering the products. The wholesalers and stockists will be contacted by the company representatives so that arrangement can be made to retrieve all stocks concerned from the wholesalers and stockists.
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RECALL PROCEDURE
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RESPONSIBILITY
The General Manager (the highest person in management) has the ultimate responsibility to direct the prompt removal of defective/recalled products from the market. The Quality Control Manager is responsible for the assignment of a Qualified Recall Team and determining the recall strategy. The Recall Team is responsible to carry out all recall activities under the supervision of Recall Team Leader. The Recall Team Leader is responsible for execution and coordination of all recall activities and to evaluate the effectiveness of the recall in a suitable interval.
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PRODUCT RECALL MANAGEMENT

Organizing the return of the recalled product :

Producer should settle a centre to collect and store all returned stocks of the recalled product; All needed data, quantity, and nature of product shall be noted down by this centre as records; Depending on the class of product recall, the producer should manage the most effective and appropriate mode of transportation of recalled products; All stocks of the recalled products will be stored separately in a different section of the warehouse to prevent any mix-up. The producer has to prepare a progress report of the recall including the reconciliation between the delivered and recovered quantities
Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 1423

FATE OF PRODUCT RECALL

All available records and information on the returned stocks will be collected for evaluation purpose; A report of the affected stocks will be presented to the Product Recall Committee and the fate of the product shall be determined. The recalled product may be reworked if it meets appropriate standards and specifications e.g. mislabelling , etc; The recalled product shall be destroyed if the conditions under which the cosmetics product casts doubt on its safety, identity and quality; Upon approval from the relevant authorities, proper destruction with appropriate precautionary measures will be taken to ensure total elimination of affected stock; Detail destruction process, the date and quantity shall be recorded.
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THE FINAL RECALL REPORT

Final Recall Report, a written evaluation summarizing the circumstances leading to the recall, corrective actions taken and the disposition of the recalled product, will be prepared by the Recall Team once the recall is considered closed. Report consists of:
Fate of the products Reconciliation result Disposal report/certificate if any Copy of alert notification or any other form of notification
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DOCUMENTATION
Quality Control department is responsible to keep in a Recall File : effectiveness checklist, the Recalled Product Record, the Progress Report, the Recall Report, and all other pertinent correspondence. The recall files will be retained for at least one year after the expiration date of the recall lot.
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RELATED HYPERLINK DOCUMENTS

Handout of Recall Product Guidance of SOP Product Recall Guidance of SOP Product Return
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REFERENCES
1. ASEAN Guidelines for Cosmetic GMP (2003) 2. WHO EDM, Basic Principle of GMP: Complaints and Recalls, part 1 (2004) 3. Ibrahim M.L., SOP Recall Procedure, Kuala Lumpur, (June 2005)
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Project co-financed by European Union

Project co- financed by Asean

ASEAN GMP TRAINING MODULE

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

REASONS FOR RECALL

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean

Module 12 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14-

Project co-financed by European Union

Project co- financed by Asean