mr. shoaib hakeem how to manage recalls and withdrawls of pharmaceuticals

8/13/2019 Mr. Shoaib Hakeem How to Manage Recalls and Withdrawls of Pharmaceuticals

1/25

Servier Pakistan 1

How to Manage Recalls andWithdrawals of Pharmaceuticals

PRESENTED BY:

SH !"B H!#EEMPlant Director

SER$"ER % P!#"ST!N

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


2/25

Servier Pakistan 2

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

?+!&& , THE D!Y

How to Manage Recalls and Withdrawals of Pharmaceuticals


3/25

Servier Pakistan 3

WHEN S!,ETY !ND E,,"+!+Y ,

PH!RM!+E-T"+!& ,"N"SHED PR D-+T

THRE!THENS H-M!N &",E



4/25

Servier Pakistan 4

RE+!&&is defined as:

the returning of all or some units of a particular batch or severalbatches of a pharmaceutical product which has been marketed, backto the manufacturers warehouse so as to prevent the use of the

product if a serious quality defect is either suspected or is recordedand 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 severalbatches for reasons of quality,

Withdrawal: withdrawal concerns the entire production of a product,for regulatory or pharmacovigilance reasons.



5/25

Servier Pakistan 5

+ 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 followingclassification.



6/25

Servier Pakistan 6

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

or !"ample

rong product #label and contents are different*$ight product but wrong dosage with serious potential medicalconsequences&hemical contamination entailing serious potential medical

consequences #significant impurities, cross contamination, particulatecontamination, 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



7/25

Servier Pakistan 7

&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 temporaryor 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 insertsProduct mi" up in containers



8/25

Servier Pakistan 8

&3)SS 0 %%

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

&lass2%%%2

/his is a situation in which the use of the product is unlikely to causeadverse health consequences but for which a batch recall has been

instituted for other reasons, and not covered in class % and %% ande"cluding class % 7 %% defects.



9/25


10/25

Servier Pakistan 10

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

%n order to e"ecute the prompt recall, a recall committee must alreadye"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.mailaddress* of the members of product recall committee must be available.



11/25

Servier Pakistan 11

!-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 isinformed and the recall is initiated.

DEPTH , RE+!&&:

'epending on the recall classification and the products distribution.$ecall strategy will specify the level in the distribution chain to whichthe recall is to be e"tended.



12/25

Servier Pakistan 12

$!&)33 /:P! ) /he consumer level$!&)33 /:P! B )ll distribution levels$!&)33 /:P! & &ertain distribution levels

RE+!&& PR +ED-RES:

%f recall becomes necessary, it must be e"ecuted immediately andefficiently./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 recallhas to be processed after working hours or on holidays.



13/25

Servier Pakistan 13

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.



14/25

Servier Pakistan 14

/hese must be informed of the reasons and causes for recall and of theconsequences 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 'istributorsand 9rgani;ations within the distribution channel.

/his procedure must be carried out as quickly as possible2usingmethods of communication according to the level involved #fa",telephone, mail, media print6electronic etc.*



15/25

Servier Pakistan 15

/hey must be given a list of standard questions and answers and passon 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 healthauthorities, health care professionals, pharmacists #private, hospitals,clinics* and the distribution channel concerned.

)ll products recalled are taken into stock and handled using thecurrently applicable return procedure.

&arry out regular reconciliation of the concerned product #comparison ofquantities returned in relation to quantities shipped*.



16/25

Servier Pakistan 16

The 0ersons res0onsi.le for recall will 0erform the following functions:


Persons Res0onsi.le forRecall

Res0onsi.ilities

+hief E/ecuti2e fficer < 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.

3+43! Head 53P6 < &oordination with $ecall &ommittee< 'rafting the final report of recall process in liaison with Plant

/echnical (ead.


17/25

Servier Pakistan 17

The 0ersons res0onsi.le for recall will 0erform the following functions:


Persons Res0onsi.le forRecall

Res0onsi.ilities

National Sales Manager acilitate recall process through sales team.&oordination with distribution channels and sales net work fortracking and recovery of recalled product.

)dvise the sales staff to vigilantly look and sei;e any left overstock in the market6retailer shops.

Regulator7 !ffairs Manager 3ook after all legal and regulatory affairs with authoritiesregarding recall.

Warehouse Manager !nsure all contact numbers of the distributors6institutions areavailable.

/ractability of recalled product including physician samples.&learly separate segregation of recalled goods in thewarehouse.$ecord and reconciliation of all recalled goods.

eed back to the distribution channels regarding the quantityreceived and the quantity still pending.


18/25

Servier Pakistan 18

/he recall committee must remain available on a =>2hour basis until thecomplete 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 andshould be kept in such a way that the complete and quantitativedistribution of any batch could be determined rapidly.%n order to ascertain the effectiveness of the recall procedure, it shouldperiodically be validated.

End of Recall: hen the product has been recalled, the recall activitywill 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



19/25

Servier Pakistan 19

'estruction of $ecalled Products %n the case of destruction, the recalledproducts 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.



20/25

Servier Pakistan 20

,"N!& REP RT:

) complete report drawn up by the recall6withdrawal committee mustbe submitted to the local health authorities giving details of all actionand reconciliation, and of all action taken to investigate, understand

and correct the source of the deviation that resulted in therecall6product withdrawal.

%nterim reports must be prepared until the recall6withdrawal procedureis completed.



21/25

Servier Pakistan 21

D +-MENT!T" N:

)ll documents, files, letters action plan destruction6disposal recordetc., of the recalled products should be suitably stored in the office ofthe persons responsible for recall and should be made easilyavailable when necessary.

)ll data concerning the recalled batches and all documentationconcerning the recall procedure must be centrali;ed locally andarchived locally.

)nne"ures will be used as the formats for the e"ecution of recallprocedure.

RE+!&& TEST:

/he S9P must be tested and challenged at least once per year asper a recall drill.



22/25

Servier Pakistan 22

%n =??@, =A people died in Panama after taking a government2madecough syrup containing diethylene glycol that had been mislabeled asglycerol, a widely used e"cipient. )nother 1 people suffered sideeffects including disorientation and kidney failure.

%n ACC@, glycerol contaminated with diethylene glycol killed people

in (aiti.

hile in ACC?2ACC= paracetamol syrup contaminated with diethyleneglycol from propylene glycol led to =1@ deaths in %ndia andBangladesh.

/his illustrates the view that, in most cases, problems with e"cipientshave occurred.

Because of a failure in -4P, -SP, -'P.



23/25

Servier Pakistan 23

P%&%)S&9

%5D!S/%-)/%95

&95&3ES%95


? ?


24/25

Servier Pakistan 24

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 byeverybody e"cept professionals educated and trained on drug relatedsubGectsF&an health assurance needs be met without multidisciplinaryapproach and sincere efforts by universally recogni;ed triangle ofhealth case consisting of doctors, pharmacists and nurses.


25/25

mr. shoaib hakeem how to manage recalls and withdrawls of pharmaceuticals

Documents