This document outlines the process for handling pharmaceutical product complaints. It defines a complaint and discusses the need for proper complaint handling procedures. It classifies complaints as critical, major, or minor and describes the 4 main steps to handling complaints: receiving complaints, technical investigation, corrective and preventive actions/feedback, and trend analysis/reporting. Key aspects of each step like documentation, sampling, testing, reporting, and record keeping are described. Regulatory guidelines for complaint management are also provided.

1. UNIT IV
Ms. TENY SARA THOMAS
MOUNT ZION COLLEGE OF PHARMACEUTICAL SCIENCES AND
RESEARCH, ADOOR, KERALA
ASSISTANT PROFESSOR
B.PHARM SIXTH SEMESTER
PHARMACEUTICAL QUALITY ASSURANCE

2. COMPLAINTS
• Despite all the precautions taken, some
problems may occur in a given drug
product.
• The customer finds the faults in the
product.
• And the dissatisfaction is conveyed in the
form of a COMPLAINT.
• Complaints are then investigated and
corrective actions are taken.

3. DEFINITION
• Complaint is defined as statement that is
something wrong or not good enough,
which shows customer dissatisfaction
about the company and the product.
• Example: complaining about the drug
product or the packaging materials etc.
• All complaints concerning defective
products should be carefully reviewed
according to written procedures.

4. NEED FOR COMPLAINT HANDLING
• Gives the company an opportunity to improve
the quality of the product.
• Helpful to maintain cGMP.
• Maintains committed relationship between the
customer and company.
• Reduce costs and improve production
schedules.
• Reduce employee confusion.
• Improve safety and performance of devices.

5. CLASSIFICATION OF COMPLAINTS
A. CRITICAL COMPLAINTS
• Individual defects which can be critical and require the
company to take in need of attention action by all
reasonable resources, whether in and out of company
hours.
Example: microbial contamination of a sterile product.
B. MAJOR COMPLAINTS
• These complaints will possibly put the patient at a little
hazard but are not life threatening and will require
product recall within a few days.
example: any labelling/leaflet misinformation.
C. MINOR DEFECTS
• Complaints which present only a significant risk to patient.
Example: readily visible inaccessible packaging/closure faults.

6. STEPS TO HANDLE COMPLAINTS
Good Complaint Handling Procedure are
implemented by steps which are divide into
four.
1. Receiving Complaints
2. Technical Investigation
3. Corrective and Preventive Actions(CAPA)
/ Feedback to Customers.
4. Trend Analysis / Monthly Reports

7. RECEIVING COMPLAINTS
• Complaints must provide open channels
through which customers can arise their
complaints
• The company must appoint a person who
will be responsible for receiving the
complaint, and documenting it as per
company requirements.
• The most flexible channels are toll-free
numbers and chat-rooms.

8. CUSTOMER
COMPANY’s
CONTACT
PERSON
QUALITY
COMPLAINT
OFFICER
Make complaint
through toll free
no. , e-mails, chat
room
• Open the
investigation,
including
information, about
the customer and
about the complaint
• ask the customer
to return the
product for analysis
STEP 1

9. TECHNICAL INVESTIGATION
Once the complaint has been received, a
complaint investigation form should be
prepared with the following information:-
• Name and contact details of complainant.
• Details of the drug product on which
complaint has been raised – product name,
manufacturing batch number, lot number,
manufacture and expiry dates, quantity of
product where problem is seen
• Details of the nature of complaint – what
exactly is wrong and has been complained
about.

10. Product complaint data sheet details include:-
• Serial number of complaint
• Complaint details
• Name and address of the complainant.
• Date of receiving the complaint
• Name of the person who received the complaint.
• Details of the product – name, strength, batch number
• Size of sample obtained from the complainant.
• Complaint evaluation report.
• Name and sign of the investigators with date.
• Action taken report
• Copy of written response sent to complainant.

11. • All this information is sent to the Quality
Assurance department to start investigation. A
QA officer is appointed as Complaint Officer
to oversee the next stages.
• Two phases of investigation will follow:-
1. Document Based investigation
2. Laboratory Analysis

12. DOCUMENT BASED INVESTIGATION
This involves review of :-
• Complaint files to see how many previous
complaints of a similar nature have occurred,
and how the complaints were handled.
• Batch manufacturing and packaging records
to check for any incidents of non-
conformance during that particular batch’s
processing.

13. LABORATORY ANALYSIS
• This phase involves analysis by the Quality
Control laboratory. The samples received
with the complaint as well as the samples
that have been retained by the manufacturer
must be tested and the results are
documented.
The Complaint Officer compares the results of
the laboratory analysis and the document
based investigation and prepares a report that
may result in one of the conclusions:-
• Confirmed complaint
• Non – Confirmed complaint
• Counterfeit/ Tamper Suspicion

14. • Confirmed Complaint – when out of specification
(OOS) results are seen in both complaint and
retained or in only complaint samples. For e.g. if
both samples of tablets showed discolouration, o one
tablet is missing from blister pack.
• Non Confirmed Complaint – when both retained and
complaint samples test results comply with
specifications, or if complaint samples show OOS
results. For e.g. tablets in complaint sample are
discoloured but not in retained samples.
• Counterfeit/ tamper suspicion – when retained
sample meets specifications but complaint samples
are OOS, with no possible reason to explain the
deviation. For e.g. if packing material of complaint
sample is different from the retained – counterfeit
drug. Or if colour of complaint sample is totally
different from retained – tampered drug.

15. The Complaint Officer investigates if the
complaint involves any unexpected or
serious adverse drug reaction.
After complaint of investigation,
generally within 30 days of receiving the
complaint, the report is prepared and
signed by Complaint Officer and QA
manager.
the complaint file must be maintained for
at least 1 year following the expiry date of
the productive batch.

16. QA
COMPLAINT
OFFICER
Quality Assurance
department to start
investigation. The
Complaint Officer
investigates if the
complaint involves any
unexpected or serious
adverse drug reaction.
STEP 2
1.DOCUMENT
BASED
INVESTIGATION
2.LABORATORY
ANALYSIS
COUNTERFEIT/
TAMPER SUSPICION
NONCONFIRMED
COMPLAINT
CONFIRMED
COMPLAINT

17. CORRECTIVE & PREVENTIVE ACTIONS/
FEEDBACK TO CUSTOMER
• In case of confirmed complaints, company must
implement corrective actions depending on the
severity of the problem.
A team of representatives from Production, QC, QA
and higher management areas is put together for
launching CAPA
• In case of non confirmed complaints, that may have
originated from improper handling , company sends a
written response to the complainant, including
information on the corrective method adopted. Also a
free replacement is sent to the customer.
• In case of therapeutic complaints or ADR, the
company may decide for a product recall, if they see
a risk in sale of drug.

18. CORRECTIVE ACTION
•Depend on nature of complaint
•Training
•CAPA procedures
•Product recall
STEP 3
FEEDBACK TO THE CUSTOMER
•Explanation letter to customer about the results
and reason.
•Delivery of free product as reimbursement.

19. TREND ANALYSIS/MONTHLY
REPORTS
• Monthly reports should be elaborated in order
to evaluate the amount and the nature of
complaints received and to perform a trend
analysis of these complaints.
• The monthly report must answer the
following:-
How many complaints did the company
receive in the period?
How many were confirmed, nonconfirmed
or counterfeit/tamper suspicion?

20. • Graphic methods of displaying data are important
adjuncts to data analysis and presentation.
• The report must be readily available mainly during
GMP inspections.
STEP 4
TREND ANALYSIS
•Number of reports :- category, nature, segment,
batches
•Identification and implementation of corrective
actions.
•Sharing of report with all departments.

21. DOCUMENTATION OF FINAL
REPORT ONCOMPLAINTS
• Nature of the complaint:- ____________
• Date:- __________
• Complaint:- _________________
• Originator of the complaint& title:- _____________
• Distributor contact person & title:- __________
• Method of notification:- ______________
• Name:- ____________
• Phone No:-________ P.O - ______
• Date shipped:- __________ Invoice:-_______
• Product name:-__________ Control No.:-____
• Expiry date:__________ Quantity involved:-____

22. • Total quantity shipped- ________
• Reason for complaint return request-_________
• Evaluation of complaints: -
physical characteristics
sign of deterioration
other observation
• Quality control findings:-
returned sample
returned sample re assay
initial data
quality control comments & suggestions
• Packaging or labelling or inserts evaluation.

23. Resultant action taken:
1. Method, date of customer notification & authorized:-
_________
2. Comments:- ___________
3. Completion date for action taken:-___________
4. Quality assurance evaluation:-_____________
CUSTOMER COMPLAINT RECORD BOOK
REPORT
NO.
DATE
RECEIVED
PRODUCT
NAME
RECEIVED
BY
PRODUCT
LOT NO.
DATE
INVESTIG
ATION
STARTED
DATE
INVESTIG
ATION
ENDED

24. REGULATORY GUIDELINES
• A SOP should be available giving full details about
how to handle products complaints and necessary
records about complaints should be maintained.
• A person should be designated for handling the
complaints and deciding the measures to be taken
• Person should be normally be from quality
management department.
• All decisions and measures taken as a result of a
complaint should be recorded
• If product defect is suspected in a batch, other batches
should also be checked in order to determine whether
they are also affected.
• Written records shall be maintained for at least 1 year
after the date that the complain was received.