Basic Principles of GMP

Complaints and Recalls

Part One, Sections 6 and 7

WHO - EDM
Module 5 Slide 1 of 24
 Complaints and Recalls
Product Complaint Principle

“All complaints and other information concerning

potentially defective products must be carefully reviewed
according to written procedures.”
(WHO GMP)

Part One, 7.1

WHO - EDM
Module 5 Slide 2 of 24
 Complaints and Recalls
Objectives
 To identify the key issues in product complaint and
recall handling
 To understand the specific requirements for
organization, procedures and resources
 To understand and develop actions to resolve current
issues applicable to you

WHO - EDM
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 Complaints and Recalls
Complaints Handling Principle
 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 staff member
 Thorough investigation of the cause is essential
 A major source of information and learning
 Enable possible production defects to be remedied before they lead
to a recall.
 Necessary actions taken -- even a recall decision Part One, 6.1

WHO - EDM
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 Complaints and Recalls
Complaints Procedure - I
 Designated responsible person
 May be authorized person
 If not, must advise authorized person of results
 Sufficient support staff
 Access to records
 Written procedure describing action to be taken
 Acknowledge and respond to complainant within a
reasonable period
 Record written and verbal comments Part One, 6.2 – 6.9

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 Complaints and Recalls
Complaints Procedure - II
 Investigate and review
 QA review complaint
 Appropriate follow up actions
 Review of trends

Part One, 6.2 – 6.9

WHO - EDM
Module 5 Slide 6 of 24
 Complaints and Recalls
Records of Complaint Investigation
 Name of product
 Name of active substance (INN) if necessary
 Strength, dosage form
 Batch number
 Name of complainant and nature of complaint
 Records, retention sample investigated, other batches
reviewed and staff interviewed
 Result of investigation: “Justified” or “Not justified”
 If “justified”, actions taken to prevent reoccurrence
 Sign-off upon completion
Part One, 6.4

WHO - EDM
Module 5 Slide 7 of 24
 Complaints and Recalls
Decision from a Complaint Investigation
 Complaint justified
 Actions to prevent reoccurrence
 Ongoing observation of process
 Recall product may be required

 Complaint not justified

 Advise customer of findings
 Appropriate marketing response

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Module 5 Slide 8 of 24
 Complaints and Recalls
Other issues
 Regular review of trends required
 Reoccurring problems
 Potential recall or withdrawal
 Inform competent authority of serious quality problems

Part One, 6.8

WHO - EDM
Module 5 Slide 9 of 24
 Complaints and Recalls
Classification of Defects
 If complaint is justified, then there has been a failure of the
quality system
 Once defect has been identified, company should be dealing
with it in an appropriate way, even recall.
 The definition of defects is useful.
 The following system has been found in some countries (but it is
not a WHO guideline):
 Critical defects
 Major defects
 Other defects

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Module 5 Slide 10 of 24
 Complaints and Recalls
Critical Defects
 Those defects which can be life threatening and
require the company to take immediate action by all
reasonable means, whether in or out of business
hours

Examples
 Product labelled with incorrect name or incorrect strength
 Counterfeit or deliberately tampered-with product
 Microbiological contamination of a sterile product

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 Complaints and Recalls
Major Defects
 Those defects which may put the patient at some risk but
are not life threatening and will require the batch recall or
product withdrawal within a few days

Examples
 Any labelling/leaflet misinformation (or lack of information) which
represents a significant hazard to the patient
 Microbial contamination of non-sterile products with some risk for
patients
 Non-compliance to specifications (e.g. active ingredient assay)

WHO - EDM
Module 5 Slide 12 of 24
 Complaints and Recalls
Other Defects
 Those defects which present only a minor risk to the
patient — batch recall or product withdrawal would
normally be initiated within a few days

Examples
 Readily visible isolated packaging/closure faults
 Contamination which may cause spoilage or dirt and where
there is minimal risk to the patient

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Module 5 Slide 13 of 24
 Complaints and Recalls
Reasons for Recall
 Customer complaint
 Detection of GMP failure after release
 Result from the ongoing stability testing
 Request by the national authorities
 Result of an inspection
 Known counterfeiting or tampering
 Adverse reaction reporting

WHO - EDM
Module 5 Slide 14 of 24
 Complaints and Recalls
Product Recall Principle

“There should be a system to recall from the market

promptly and effectively, products known or
suspected to be defective.”
(WHO GMP)

Part One, 7.1

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 Complaints and Recalls
Definition
 Recall
 Removal from the market of specified batches of a product
 May refer to one batch or all batches of product

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 Complaints and Recalls
Designated Responsible Recall Person
 May be authorized person
 If not, must advise authorized person of results
 Sufficient support staff for urgency of recall
 Independent of sales and marketing
 Access to records

Part One, 7.2, 7.3

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 Complaints and Recalls
SOP for Recall
 Established, authorized
 Actions to be taken
 Regularly checked and updated
 Capable of rapid operation to hospital and pharmacy level
 Communication concept to national authorities and
internationally

Part One, 7.2, 7.3

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Module 5 Slide 19 of 24
 Complaints and Recalls
Distribution Records
 Available to designated person for recall purposes
 Accurate
 Include information on:
 Wholesalers
 Direct customers
 Batch numbers
 Quantities
Part One, 7.4, 7.5

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Module 5 Slide 20 of 24
 Complaints and Recalls
 Written progress report and reconciliation
 Record progress as procedure followed
 Reconcile delivered with recovered products
 Issue final report

 Effectivemess of procedures checked

 Test effectiveness from time to time

 Secure segregated storage of returned goods

 Essential to keep returned goods away from other goods
Part One 7.6 - 7.8

WHO - EDM
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