complaints & record

8/7/2019 complaints & record

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Module 5 Slide 1 of 24 WHO - EDM

Part One, Sections 6 and 7

Basic Principles of GMP

Complaints and Recalls


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C omplaints and RecallsObj ectives

T o identify the key issues in product complaint andrecall handlingT o understand the specific requirements fororganization, procedures and resourcesT o understand and develop actions to resolve currentissues applicable to you


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Part One, 6.2 6.9

C omplaints and RecallsComplaints Pr ocedu r e - I

D esignated responsible person May be authorized personIf not, must advise authorized person of resultsSufficient support staff Access to records

Written procedure describing action to be taken

Acknowledge and respond to complainant within areasonable period

Record written and verbal comments


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Part One, 6.2 6.9

C omplaints and RecallsComplaints Pr ocedu r e - II

Investigate and review

QA review complaintAppropriate follow up actions

Review of trends


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Part One, 6.4

C omplaints and RecallsReco r ds of Complaint Investigation

N ame of productN ame of active substance ( INN ) if necessary

Strength, dosage formBatch numberN ame of complainant and nature of complaintRecords, retention sample investigated, other batchesreviewed and staff interviewedResult of investigation: Justified or N ot justifiedIf justified, actions taken to prevent reoccurrenceSign-off upon completion


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C omplaints and RecallsD ecision f r om a Complaint Investigation

C omplaint justified

Actions to prevent reoccurrenceOngoing observation of processRecall product may be required

C omplaint not justified Advise customer of findings Appropriate marketing response


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Part One, 6.8

C omplaints and RecallsO the r issues

Regular review of trends requiredReoccurring problemsPotential recall or withdrawal

Inform competent authority of serious quality problems


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C omplaints and RecallsClassification of D efects

If complaint is justified, then there has been a failure of thequality system

Once defect has been identified, company should bedealing with it in an appropriate way, even recall.T he definition of defects is useful.T he following system has been found in some countries(but it is not a WHO guideline):

C ritical defects Major defectsOther defects


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C omplaints and RecallsCr itical D efects

T hose defects which can be life threatening andrequire the company to take immediate action by allreasonable means, whether in or out of businesshours

Examples

Product labelled with incorrect name or incorrect strengthC ounterfeit or deliberately tampered-with product Microbiological contamination of a sterile product


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C omplaints and RecallsM a jor D efects

T hose defects which may put the patient at some risk butare not life threatening and will require the batch recall or

product withdrawal within a few daysExamples

Any labelling/leaflet misinformation (or lack of information) whichrepresents a significant hazard to the patient

Microbial contamination of non-sterile products with some risk for patientsNon-compliance to specifications (e.g. active ingredient assay)


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C omplaints and RecallsO the r D efects

T hose defects which present only a minor risk to thepatient batch recall or product withdrawal wouldnormally be initiated within a few days

Examples

Readily visible isolated packaging/closure faultsC ontamination which may cause spoilage or dirt and wherethere is minimal risk to the patient


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C omplaints and RecallsReasons fo r Recall

C ustomer complaintD etection of GMP failure after release

Result from the ongoing stability testing

Request by the national authorities

Result of an inspection

Known counterfeiting or tamperingAdverse reaction reporting


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C omplaints and RecallsD etection of G M P failu r e

T he photo shows an active tablet in the rowof placebos in a bi-phasic oral contraceptive

blister pack.


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Part One, 7.1

C omplaints and RecallsPr oduct Recall Pr inciple

T here should be a system to recall from the marketpromptly and effectively, products known orsuspected to be defective.

(WHO GMP)


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C omplaints and RecallsD efinition

RecallRemoval from the market of specified batches of a product May refer to one batch or all batches of product


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Part One, 7.2, 7.3

C omplaints and RecallsD esignated Responsi b le Recall P er son

May be authorized personIf not, must advise authorized person of results

Sufficient support staff for urgency of recallIndependent of sales and marketing

Access to records


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Part One, 7.2, 7.3

C omplaints and RecallsS O P fo r Recall

Established, authorized

Actions to be taken

Regularly checked and updatedC apable of rapid operation to hospital and pharmacy levelC ommunication concept to national authorities and

internationally


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Part One, 7.4, 7.5

C omplaints and RecallsD ist r ibution Reco r ds

Available to designated person for recall purposes

AccurateInclude information on:

W holesalersDirect customers

Batch numbersQuantities


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Part One 7.6 - 7.8

C omplaints and RecallsW r itten p r og r ess r epo r t and r econciliation

Record progress as procedure followedReconcile delivered with recovered products

Issue final report

E ffectivemess of p r ocedu r es checkedTest effectiveness from time to time

S ecu r e seg r egated sto r age of r etu r ned goodsEssential to keep returned goods away from other goods

Documents

complaints & record