How to Manage Recalls and Withdrawals of Pharmaceuticals

PRESENTED BY:
SH !"B H!#EEM Plant Director SER$"ER % P!#"ST!N

!PR"& '() '*(' % "S&!M!B!D

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How to Manage Recalls and Withdrawals of Pharmaceuticals

WHY RE+!&&S !ND W"THDR!W!&S

+!&&

?
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, THE D!Y
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How to Manage Recalls and Withdrawals of Pharmaceuticals

WHEN

S!,ETY

!ND

E,,"+!+Y

PH!RM!+E-T"+!& ,"N"SHED PR D-+T THRE!THENS H-M!N &",E

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How to Manage Recalls and Withdrawals of Pharmaceuticals

RE+!&& is defined as: the returning of all or some units of a particular batch or several batches of a pharmaceutical product which has been marketed, back to the manufacturers warehouse so as to prevent the use of the product if a serious quality defect is either suspected or is recorded and confirmed with a possible risk to a consumer. Differentiation .etween Recall and Withdrawal:

Recall: recall may involve a single batch, part of a batch or several batches for reasons of quality, Withdrawal: withdrawal concerns the entire production of a product, for regulatory or pharmacovigilance reasons.
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How to Manage Recalls and Withdrawals of Pharmaceuticals

+ ND"T" NS

, RE+!&&

Become necessary if serious quality defects are reported by !"ternal Sources #$egional distributors, %nstitutional distributors, $etailers, &onsumers, 'octors, (ospitals and State (ealth )uthorities*. %nternal Sources #Sales 'epartment, +uality &ontrol 'epartment, ,inished -oods .arehouse, $egulatory )ffairs 'epartment*. /he defects in the quality should be classified according to following classification.

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How to Manage Recalls and Withdrawals of Pharmaceuticals

&lass 0 % 0 Potentially 'angerous /his is a situation in which there is a reasonable probability that the use of, or e"posure to, the product will cause serious adverse health consequences or death. ,or !"ample

.rong product #label and contents are different* $ight product but wrong dosage with serious potential medical consequences &hemical contamination entailing serious potential medical consequences #significant impurities, cross contamination, particulate contamination, suspicion of contamination or sabotage by a 1rd party* .rong active substance in a multi2ingredient product entailing serious potential medical consequences /hird party tempering or adulteration
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How to Manage Recalls and Withdrawals of Pharmaceuticals

&lass 0 % % 0 'efect likely to result in disease or inappropriate therapy, e"cluding class % /his is a situation in which the use of the product may cause temporary or medically reversible adverse consequences or where the probability of serious adverse health consequences are remote.

,or !"ample 3abeling error #te"t or data erroneous or missing* 4issing or incorrect information on printed te"t or package inserts Product mi" up in containers

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How to Manage Recalls and Withdrawals of Pharmaceuticals

&3)SS 0 %%

5on2compliance with specifications #tests6content, stability, content6weight*. 'eviation due to degradation of the product seen by reviewing stability

&lass2%%%2

/his is a situation in which the use of the product is unlikely to cause adverse health consequences but for which a batch recall has been instituted for other reasons, and not covered in class % and %% and e"cluding class % 7 %% defects.

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How to Manage Recalls and Withdrawals of Pharmaceuticals

&3)SS 0 %%% ,or E/am0le:

'efective packaging #batch number or e"piry date erroneous or missing*, storage incident 'efective closures &ontaminated by dust or particles %f recall becomes necessary, it must be e"ecuted immediately and efficiently. /he purpose is to prevent the possibility of risk to patients or damage to the companys public image
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How to Manage Recalls and Withdrawals of Pharmaceuticals

PR D-+T RE+!&& + MM"TTEE:

%n order to e"ecute the prompt recall, a recall committee must already e"ist. /he committee will comprise of the following members &hief !"ecutive of the company. 5ational Sales 4anager. /echnical 'irector6(ead of Production. +)6+& #+ualified person 7 $ecall &oordinator*. $egulatory )ffairs 4anager. .arehouse 4anager. /he name, designation, contact numbers #telephone 8, fa" 8, e.mail address* of the members of product recall committee must be available.

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How to Manage Recalls and Withdrawals of Pharmaceuticals

!-TH R"TY T

RDER ! RE+!&&:

)s the qualified person #+P*, designated by management #responsible for batch release* is the recall coordinator. 9nce quality defect has been detected or suspected.

.ill evaluate the need to recall. 9nce a decision has been taken, the &hief !"ecutive 9fficer is informed and the recall is initiated. , RE+!&&:

DEPTH

'epending on the recall classification and the products distribution. $ecall strategy will specify the level in the distribution chain to which the recall is to be e"tended.
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How to Manage Recalls and Withdrawals of Pharmaceuticals

$!&)33 /:P! ) $!&)33 /:P! B $!&)33 /:P! & RE+!&& PR +ED-RES:

/he consumer level )ll distribution levels &ertain distribution levels

%f recall becomes necessary, it must be e"ecuted immediately and efficiently. /he purpose is to prevent the possibility of risk to patients or damage to the companys public image. /op priority will be given to recall work by all concerned, even if recall has to be processed after working hours or on holidays.

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How to Manage Recalls and Withdrawals of Pharmaceuticals

PREP!R!T RY ME!S-RES: Tas1s of Recall +ommittee:

/he recall committee must +uarantine stock and6or recalled stock. !ither holding in stock or have distributed.

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How to Manage Recalls and Withdrawals of Pharmaceuticals

/hese must be informed of the reasons and causes for recall and of the consequences thereof. Specify the type and level of the recall #'istributors, %nstitutional 'istributors, $etailer, &onsumer etc.* %nform the local health authorities for a decision regarding recall. Send the recall order to $egional 'istributors, %nstitutional 'istributors and 9rgani;ations within the distribution channel. /his procedure must be carried out as quickly as possible2using methods of communication according to the level involved #fa", telephone, mail, media print6electronic etc.*

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How to Manage Recalls and Withdrawals of Pharmaceuticals

/hey must be given a list of standard questions and answers and pass on the information through the appropriate channels #e.g., sales team*. .here the situation so warrants, the media are to be informed by a suitable written communication where necessary for the health authorities, health care professionals, pharmacists #private, hospitals, clinics* and the distribution channel concerned. )ll products recalled are taken into stock and handled using the currently applicable return procedure. &arry out regular reconciliation of the concerned product #comparison of quantities returned in relation to quantities shipped*.

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How to Manage Recalls and Withdrawals of Pharmaceuticals

The 0ersons res0onsi.le for recall will 0erform the following functions:
Persons Res0onsi.le for Recall +hief E/ecuti2e fficer < < Res0onsi.ilities ,acilitate the task of $ecall &oordinator #+P* 3iaison with head office regarding $ecall

Technical Plant Head

< < < < < < <

Supervision of all activities within the plant regarding $ecall. %nitiation of recall in liaison with +& 4anager. %nvestigation of recall in liaison with +& 4anager #if applicable* ,acilitate the task of $ecall &oordinator #+P* 'rafting the final report of recall process in liaison with +& 4anager. &oordination with $ecall &ommittee 'rafting the final report of recall process in liaison with Plant /echnical (ead.

3+43! Head 53P6

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How to Manage Recalls and Withdrawals of Pharmaceuticals

The 0ersons res0onsi.le for recall will 0erform the following functions:
Persons Res0onsi.le for Recall National Sales Manager

Res0onsi.ilities ,acilitate recall process through sales team. &oordination with distribution channels and sales net work for tracking and recovery of recalled product. )dvise the sales staff to vigilantly look and sei;e any left over stock in the market6retailer shops. 3ook after all legal and regulatory affairs with authorities regarding recall. !nsure all contact numbers of the distributors6institutions are available. /ractability of recalled product including physician samples. &learly separate segregation of recalled goods in the warehouse. $ecord and reconciliation of all recalled goods. ,eed back to the distribution channels regarding the quantity received and the quantity still pending.
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Regulator7 !ffairs Manager

Warehouse Manager

How to Manage Recalls and Withdrawals of Pharmaceuticals

/he recall committee must remain available on a =>2hour basis until the complete recall of product has been accomplished. PR D-+T D"STR"B-T" N RE+ RD SYSTEM: Product distribution records are the basis of an effective recall and should be kept in such a way that the complete and quantitative distribution of any batch could be determined rapidly. %n order to ascertain the effectiveness of the recall procedure, it should periodically be validated. End of Recall: .hen the product has been recalled, the recall activity will be declared completed by the recall coordinator. ,ate of Recalled Stoc1: ,ate of the recalled stock will be decided, keeping in view the classification of defects defined in clause

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How to Manage Recalls and Withdrawals of Pharmaceuticals

'estruction of $ecalled Products %n the case of destruction, the recalled products must be destroyed according to S9P.

/he destruction can only take place after

/otal reconciliation of the quantity of recalled products. )uthori;ation by &hief !"ecutive 9fficer. Should also involve (ealth )uthorities.

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How to Manage Recalls and Withdrawals of Pharmaceuticals

,"N!& REP RT:

) complete report drawn up by the recall6withdrawal committee must be submitted to the local health authorities giving details of all action and reconciliation, and of all action taken to investigate, understand and correct the source of the deviation that resulted in the recall6product withdrawal. %nterim reports must be prepared until the recall6withdrawal procedure is completed.

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How to Manage Recalls and Withdrawals of Pharmaceuticals

D +-MENT!T" N:

)ll documents, files, letters action plan destruction6disposal record etc., of the recalled products should be suitably stored in the office of the persons responsible for recall and should be made easily available when necessary. )ll data concerning the recalled batches and all documentation concerning the recall procedure must be centrali;ed locally and archived locally. )nne"ures will be used as the formats for the e"ecution of recall procedure.

RE+!&& TEST:

/he S9P must be tested and challenged at least once per year as per a recall drill.
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How to Manage Recalls and Withdrawals of Pharmaceuticals

%n =??@, =A people died in Panama after taking a government2made cough syrup containing diethylene glycol that had been mislabeled as glycerol, a widely used e"cipient. )nother 1B people suffered side effects including disorientation and kidney failure. %n ACC@, glycerol contaminated with diethylene glycol killed BB people in (aiti. .hile in ACC?2ACC= paracetamol syrup contaminated with diethylene glycol from propylene glycol led to =1@ deaths in %ndia and Bangladesh. /his illustrates the view that, in most cases, problems with e"cipients have occurred. Because of a failure in -4P, -SP, -'P.
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How to Manage Recalls and Withdrawals of Pharmaceuticals

P%& ,%)S&9 %5D!S/%-)/%95

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Some Serious 3uestion:

.as it the first incident of its kind in the worldF (ow did the world respond to such incidentsF .hy the preventable deaths not stopped through stoppage of further use or effective drug recallF %s there any law to deal with such casesF (ave we learnt the lessonsF .as the investigation fair and scientificF &an drug related issues including pharmaceutical care be solved by everybody e"cept professionals educated and trained on drug related subGectsF &an health assurance needs be met without multidisciplinary approach and sincere efforts by universally recogni;ed triangle of health case consisting of doctors, pharmacists and nurses.

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THANK YOU
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