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