Complaints and Recalls

Basic Principles of GMP
Complaints and Recalls
Part One, Sections 6 and 7
Module 5
Slide 1 of 24
WHO - EDM

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
Module 5
Slide 2 of 24
WHO - EDM

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
Module 5
Slide 3 of 24
WHO - EDM

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.
Part One, 6.1
Necessary actions taken -- even a recall decision
Module 5
Slide 4 of 24
WHO - EDM

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
Module 5
Slide 5 of 24
Part One, 6.2 6.9
WHO - EDM

Complaints Procedure - II
Investigate and review
QA review complaint
Appropriate follow up actions
Review of trends
Part One, 6.2 6.9
Module 5
Slide 6 of 24
WHO - EDM

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
Module 5
Slide 7 of 24
WHO - EDM

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
Module 5
Slide 8 of 24
WHO - EDM

Other issues
Regular review of trends required

Reoccurring problems
Potential recall or withdrawal
Inform competent authority of serious quality

problems
Part One, 6.8
Module 5
Slide 9 of 24
WHO - EDM

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
Module 5
Slide 10 of 24
WHO - EDM

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
Module 5
Slide 11 of 24
WHO - EDM

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)
Module 5
Slide 12 of 24
WHO - EDM

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
Module 5
Slide 13 of 24
WHO - EDM

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
Module 5
Slide 14 of 24
WHO - EDM

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
Module 5
Slide 16 of 24
WHO - EDM

Definition
Recall
Removal from the market of specified batches of
a product
May refer to one batch or all batches of product
Module 5
Slide 17 of 24
WHO - EDM

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
Module 5
Slide 18 of 24
WHO - EDM

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
Module 5
Slide 19 of 24
WHO - EDM

Distribution Records
Available to designated person for recall

purposes
Accurate
Include information on:

Wholesalers
Direct customers
Batch numbers
Quantities
Module 5
Slide 20 of 24
Part One, 7.4, 7.5
WHO - EDM
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
Part goods
One 7.6 - 7.8
Module 5
Slide 21 of 24
WHO - EDM

Group Session
Collect 3 examples of complaints or recalls

from your experience
Describe the actions to be taken by the

company or authority and the implications for
all interested parties
Suggest a classification of the complaint or

recall into critical (life threatening), major or
other
Module 5
Slide 22 of 24
WHO - EDM

Possible Issues I
No response to justified complaints
Response to unjustified complaints
Failure to recall
Failure to correct frequent complaints
No resources to investigate
No senior management support
Senior management interference
Module 5
Slide 23 of 24
WHO - EDM

Possible Issues II
No distribution information/batch records
No access to records
Inability to contact government during

holidays/weekends
Disagreement on severity of defect
Module 5
Slide 24 of 24
WHO - EDM

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Basic Principles of GMP