COMPLAINTS
TOPIC COVERED
1.Definition
2.Principle
3.Need for complaint handling system
4.Objectives
5.Responsibility
6.Type of complaints (CRITICAL,MAJOR ,MINOR)
7.Key for handling complaint
8.Content of product complaint data sheet
9.Steps involved in handling of complaint
10.Recordings of complain
2. Defination
Principle
Need for complaint handling system
Objectives
Responsibility
Type of complaints (CRITICAL,MAJOR ,MINOR)
Key for handling complaint
Content of product complaint data sheet
Steps involved in handling of complaint
Recordings of complain
3. COMPLAINTS
SOMETHING WRONG or NOT GOOD ENOUGH
IN PHARMACEUTICAL INDUSTRY,
complaints are regarding quality of the drug product.
A COMPLAINT SHOWS CUSTOMERS DISSATISFACTION ABOUT PRODUCT AND
CONSEQUENTLY, ABOUT COMPANY.
4. PRINCIPLE
All complaints and other information
Concerning potentially defective product
Should be carefully received
According to written procedure
And corrective action should be taken.
5. Need for complaint handling system
It gives opportunity to improve quality of the product.
It is helpful to maintain cGMP.
It maintains committed relationship between customer
and company.
Regulatory obligation.
6. OBJECTIVE
Immediately recall, investigate or take remedial measure
against defective product.
RESPONSIBILITY
The quality manager along with manager of
complaint related department .
7. Type of complaint
QUALITY COMPLAINT
• Originate at consumer level and concern with physical, chemical and biological property
• Condition of labeling/packaging of product
ADVERSE REAACTION
COMPLAINT
• Due to allergic reaction of any other untoward reaction or fatal or near fatal reaction
OTHER MEDICALLY
RELATED COMPLAINT
• Includes lack of efficacy or clinical response
8. TIME PERIOD FOR INVESTIGATION AFTER
RECEIPT OF COMPLAINT
• PRODUCT QUALITY
COMPLAINT
1O DAYS
• ADVERSE REACTION
COMPLAINTS
5 DAYS
• MEDICAL
COMPLAINTS
3 DAYS
9. Type of complaint
CRITICAL
• Can be life threatening
and require company to
take immediate action
(even out of business
hours
• Eg microbiological
contamination of sterile
product ; product with
incorrect name or
incorrect strength
MAJOR
• May put the patient at
some risk but are not life
threatening and will
require batch recall or
product withdrawal
within few days
• Eg microbial combination
of non sterile
product(some risk for
patient);lack of
information
(labeling/leaflet)
MINOR
• Minor risk to patient
batch recall or product
withdrawal would
normally be initiated
within a few day
• Eg visible isolated
packaging/closure fault ;
Contamination which
may cause spoilage or dirt
and where there is
minimal risk to the
patient
10. Key points for handling complaints
Don’t take it personally.
Never act on a complaint without hearing two side story.
Say what you will do and do what you say; set the time
. frame.
Keep notes
11. Content of a product complaint data sheet
Serial number assigned to the complaints.
Exact nature of the complaints.
Name of the complaints.
Address of the complaints.
Date of the complaint received.
Name of the product, strength and batch number of the product.
Quantity involved in the complaint.
Size of the sample obtained by QC department.
Name and signature of the investigator and date.
Action taken by the company.
Copy of reply sent to complains.
12. STEPS INVOLVE IN HANDLING
COMPLAINTS
RECIVING COMPLAINTS
TECHNICAL INVESTIGATION
CORRESCTIVE ACTION AND PREVENTIVE ACTION
FEEDBACK TO CUSTOMER
MONTHLY REPORT AND TREND ANALYSIS
13. 1.RECEIVING COMPLAINTS
Its important to have a open channel with customer in order to receive their
suggestions, doubts and complaints.
These channel are toll free number, e-mail, chat room and P.O. boxes.
Its necessary to have a person in charge of receiving the complaints and
inputting them into an appropriate investigation form that shall be addressed
to quality assurance unit for investigarion.
14. 2.TECHNICAL INVESTIGATION
Upon the receipt of investigation form, the QA unit is able to start
investigation.(they are divided into 2 phase DOCUMENTATION BASED and
LABORATOTY ANALYSIS)
DOCUMENTATION BASED INVESTIGATION:-
-consist of checking if this complaint occurred previously in the same lot or if
any non-conformance was found in the lot during its production that could
explain the complaint.
-the primary documentation to be reviewed in this step consist of the
complaint files and the batch record.
LABORATORY BASED INVESTIGATION:
consist of requesting the QC laboratory to analyze both complaint samples –
reserve sample representative of lot of manufacture.
15. LABORATORY BASED INVESTIGATION:
consist of requesting the QC laboratory to analyze both complaint samples –
reserve sample representative of lot of manufactured.
-if the customer did not send complaint sample for analysis, the laboratory
investigation will be carried out only with retained samples.
-similar to the receiving step, it is fundamental that the company elects a person in
the QA unit to be in charge of technical investigation of each complaint e.g.
Complaint Officer.
-after receiving the analytical results, there are three possible conclusion:
i. Confirmed Complaint
ii. Non-Conformed Complaint
iii. Counterfeit/ Tamper suspicion
16. 3.CORRECTIVE ACTION AND PREVENTIVE ACTION
CORRECTIVE ACTION (eliminate detected non-conformity)
oIt aims to correct an existing non-conformity and avoid reoccurrence of same
conformity.
oEg: arises from manufacturing deviations, OOS investigation, complaints audit
findings, recall.
PREVENTIVE ACTION (prevent Non-conformity occurrence)
oIt aims to avoid the initial occurrence of a non-conformity by pro-actively
implementing improvement.
oEg: result from trending in process data, of analytical data, of audit findings,
trending of root causes for non-conformities or complaints, from product
quality reviews (annual product reviews), quality risk analysis.
17. For all confirmed complaints, corrective actions must be implemented. These
actions can range from a simple and quick training to some employees to a formal
Corrective action and Preventive active (CAPA) handling.
The criteria for choosing appropriate action depends on the nature of the
complaint, and the complaint incidence.
If a CAPA is opened, a multidisciplinary team consisting of representatives of QA,
QC, Regulatory affairs and Production Management must be established.
Concerning non-conformed complaints originating from the misuse or inadequate
handling of the drug product, even if there is no need for internal corrective actions,
corrective measures should be implemented to provide orientation to the customer.
Regarding counterfeit or tampered suspicious complaints, a response letter should
also be sent to the customer, but the legal affairs unit must be copied for further
arrangements.
18. 4.FEEDBACK TO CUSTOMERS
As feedback to the customer, the company must write a response letter to the
complaint to explain the investigation approach taken, the results obtained and any
implications, in case the quality problem was comfirmed.
The customer should be sent a free replacement product together with the response
letter, since the customer returned to the product (the complaint sample) to the
company for analysis and
5.MONTHLY REPORTS AND TREND ANALYSIS
Monthly reports should be elaborated in order to evaluate the amount and the
nature of the complaints received and to perform a trend analysis of these
complaints.
19. RECORDING OF COMPLAINTS
Its responsibility of the in-charge, Quality control to see that each complaint is
recorded, evaluated and reported to the management.
Includes the following information:
1. Content Complaints- these should include:
•Name, dosage form, package form, batch number
•Date and the place of occurrence of complaints
•Cause of complaints
•Name and address of complaint in detail
20. 2. Results of investigation : it include
•Regarding market place, circulation condition and condition in which
the defect was observed.
•Results of investigation of analysis and testing records, production
and storage records.
3. Evaluation
4. Follow up measures : it include
•Reply to the complainant.
•Remedial action so that complaint of this type should not reoccur.
