Basic Principles of GMP
Complaint s and Recalls
Module 7
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
Module 7
Complaints and Recalls
Complaints Procedure
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 7
Complaints and Recalls
Complaints Procedure
Investigate and review
QA review complaint
Appropriate follow up actions
Review of trends
Module 7
Complaints and Recalls
Records of Complaint Investigation
Module 7
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
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
Module 7
Complaints and Recalls
Other issues
Regular review of trends required
Reoccurring problems
Potential recall or withdrawal
Module 7
Inform competent authority of serious quality
problems
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.
Critical defects
Major defects
Other defects
Module 7
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
Module 7
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)
Module 7
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
Module 7
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
Module 7
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.
Recall
Removal from the market of specified batches of
a product
May refer to one batch or all batches of product
Module 7
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
Module 7
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
Module 7
Complaints and Recalls
Distribution Records
Available to designated person for recall
purposes
Accurate
Include information on:
Wholesalers
Direct customers
Batch numbers
Quantities
Module 7
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
Module 7
Basic Principles of GMP
Self-Inspection
Module 7
Self-Inspection
Principle
Ensures that a companys operations remain compliant
with GMP
Assists in ensuring continuous quality improvement
Should
cover all aspects of production and quality control
be designed to detect shortcomings in the implementation
of GMP
Must
recommend corrective action if shortcomings are observed
set a timetable for corrective action to be completed
Module 7
Self-Inspection
Principle
Special occasions
inspections.
may
demand
additional
self-
For example
Recalls
Repeated rejections
GMP inspections announced by the National Drug
Regulatory Authority
Module 7
Self-Inspection
Principles
Team consist of personnel who can evaluate the
situation objectively
No conflict of interest
No revenge in mind
Should have experience as observers of a selfinspection team before becoming team member
Lead self-inspector with experience as team
member
Module 7
Self-Inspection
Carrying Out a Self-Inspection
Frequency
May depend on company requirements and the size of
the company
Report:
results
evaluation
conclusions
recommended corrective measures, if applicable
Follow-up action
Company management must evaluate both
the report and corrective actions
Module 7
Self-Inspection
Quality Audit
GMP Inspectors should encourage Quality Audits
Useful to supplement self-inspection programme
but not mandatory
Examination of all or part of quality system with
specific aim of improving it
Usually conducted by outside experts or team
appointed by management
May extend to suppliers and contractors
Module 7
Self-Inspection
Suppliers audits
QA department should have responsibility together with
other relevant departments for approving suppliers
Ensures suppliers can reliably supply materials that
meet established specifications
Avoids trying to test in quality to goods received from
dubious sources
Before suppliers are approved they should be evaluated
Evaluation does not necessarily mean an audit
Should take into account the suppliers
history and nature of materials to be supplied.
Module 7