All complaints and other information concerning potentially
defective products must be carefully reviewed according to written
procedures
Handled positively and carefully reviewed Must be seen as important
work Managed by a senior sta member Toroug
investigation of te cause is essential ! ma"or source of
information and learning #nable possible production defects to be
remedied
before tey lead to a recall$
%ecessary actions taken && even a recall decision
(f not) must advise autori'ed person of results
*u+cient support sta
Acknowledge and respond to complainant within a reasonable
period
Record written and verbal comments
Complaints and Recalls
,omplaint *ustied
,omplaint not *ustied
!dvise customer of .ndings
Reoccurring problems
Inform competent authority of serious -uality problems
Classication of Defects
If complaint is *ustied" then there has been a failure of
the -uality system
0he denition of defects is useful/
Critical defects
Ma"or defects
Critical Defects
0hose defects which can be life threatening and re-uire the
company to take immediate action by all reasonable means" whether
in or out of business hours
12amples
Counterfeit or deliberately tampered&wit product
Microbiological contamination of a sterile product
Major Defects
0hose defects which may put the patient at some risk but are
not life threatening and will re-uire the batch recall or product
withdrawal within a few days
12amples
!ny labelling/lea0et misinformation 1or lack of information2
wic represents a signi.cant a'ard to te patient
Microbial contamination of non&sterile products wit some risk
for patients
%on&compliance to speci.cations 1e$g$ active ingredient
assay2
Other Defects
0hose defects which present only a minor risk to the patient
3 batch recall or product withdrawal would normally be initiated
within a few days
12amples
Readily visible isolated packaging/closure faults
Re-uest by the national authorities
Result of an inspection
7nown counterfeiting or tampering
Complaints and Recalls
Product Recall Principle
& 0here should be a system to recall from the market
promptly and e$ectively" products known or suspected to be
defective/)
Recall
Removal from te market of speci.ed batces of a product
!u9cient support sta$ for urgency of recall
Independent of sales and marketing
Access to records
,ommunication concept to national authorities and
internationally
Accurate
(ssue .nal report
Test efectiveness from time to time
Secure segregated storage of returned goods
Assists in ensuring continuous -uality improvement
!hould
be designed to detect sortcomings in te implementation
of GMP
set a timetable for corrective action to be completed
;or e2ample
Principles
0eam consist of personnel who can evaluate the situation
ob*ectively
No con<ict of interest
No revenge in mind
!hould have e2perience as observers of a self+ inspection team
before becoming team member
=ead self+inspector with e2perience as team member
;re-uency
May depend on company re-uirements and te si'e of te
company
Report%
results
evaluation
conclusions
;ollow+up action
>seful to supplement self+inspection programme but not
mandatory
12amination of all or part of -uality system with specic aim of
improving it
>sually conducted by outside e2perts or team appointed by
management
5ay e2tend to suppliers and contractors
1nsures suppliers can reliably supply materials that meet
established specications
Avoids trying to test in -uality to goods received from dubious
sources
#efore suppliers are approved they should be evaluated
1valuation does not necessarily mean an audit