1. COMPLAINTS
BY- KASHISH WILSON
ASSISTANT PROFESSOR
M.M.COLLEGE OF PHARMACY, MM(DU)

2. CONTENTS
• Introduction
• SOP for complaint handling
• Product Complaint Data Sheet
• Steps in handling complaints
• corrective actions and feedbacks to customers
• Monthly report and trend analysis

3. INTRODUCTION
In Pharmaceutical Industry Complaint is defined as a statement
that is something wrong or not good enough which shows the
dissatisfaction of customers about products and the company.
Examples
Complaint about product quality.
Complaints about packaging materials.

4. PRINCIPLES
All complaints and other information received
Concerning possibly faulty items
Should be carefully received
According to the written procedure, corrective action should be
taken

5. NEED FOR COMPLAINT HANDLING SYSTEM
There are the following needs for a complaint handling system:
• It presents a chance for the business to raise the caliber of the
product.
• It is beneficial to keep cGMP.
• It sustains a loyal relationship between the client and the
business.
• It is a requirement of the law.

6. SOP ON COMPLAINT HANDLING
OBJECTIVE: To outline the process for looking into and disclosing
market concerns.
RESPONSIBILITY: The quality assurance manager and the manager of
the complaint-related department are both responsible.
PROCEDURE: To make an enquiry easier, complaints must be divided
into the following categories:
• Product quality complaints (non-therapeutic).
• Packaging complaints (shortages and packaging errors).
• Medical complaints (therapeutic problems).

7. RECEIVING THE
COMPLAINTS/VERBAL
REPORT ( Details of the product,
complainant, etc. will be taken).
SPECIFIC PCR(Private Complaint
Record) will be assigned.
Example- PCR/001/11
RECALLS IF ANY
FORWARDING TO THE HEAD OF QA,
QC DEPT
INVESTIGATION OF THE
COMPLAINTS
MAINTAIN THE COMPLAINT
REGISTER

8. TIME PERIOD FOR INVESTIGATION
After receiving of complaints there are following time periods for
investigation will be taken for the following complaints:
• Product quality complaints – within 5 days.
• Packaging and quality complaints – within 10 days.
• Medical complaint – within 3 days.
Records of complaints must be kept for at least a year following
drug expiry.
A monthly summary for the management must be created after
reviewing complaint records.

9. PRODUCT NAME
1. Batch no., MFG date, Expiry
date.
2. Name/ address of the
complainant.
3. The complainant reported
through.
4. The complainant sample
enclosed is yes/no.
5. The quality of the sample is
enclosed.
6. Investigation report
7. Recommended corrective
actions.
COMPLAINT CATEGORY
1. Packaging/product quality
2. Total quantity involved.
PCR received by
3. Investigation was done by
Conclusion
confirmed/not confirmed PCR
no:
PCR approved by

10. PRODUCT COMPLAINT DATA SHEET
There are the following details complaint datasheet have:
1. Serial number of complaints
2. Exact nature of the complaints.
3. Name of the complainants.
4. Address of the complainants.
5. Date of complaint received.
6. If the verbal, name of the person who received the complaint.
7. Name of the product, strength and batch number of the product.

11. • The quantity involved in the complaint.
• Size of the sample obtained from the complainant.
• Evaluation of complaint by QC department.
• Materials and records were used to perform the evaluation.
• Other possible affected materials, products and results
of their investigation.
• Name and signature of the investigator(s) and date.
• Action was taken by the company.
• Copy of reply sent to the complainant.

12. STEPS IN HANDLING COMPLAINTS
The suggested handling method is given in four parts and
complies with the GMP Guidelines of the EU, USA, and Brazil.
1. Receiving complaint
2. Technical investigation
3. Corrective actions/feedback to customers.
4. Monthly reports/trend analysis

13. RECEIVING COMPLAINTS
To accept recommendations, questions, and complaints from
clients, it is important to have open lines of communication.
There are the following channels for receiving complaints from
the customer:
a. Toll-free numbers (more flexible).
b. E-mails
c. Chat rooms
d. P.O. Boxes
The task of receiving complaints and entering them into the
proper investigative forms that will be addressed must be
assigned to someone.

14. CUSTOMER
Company’s Contact
person
QA complaint
officer
The investigation will be open.
The following information
should be taken like customer
details(Name, address, contact
details) and product
details(product name, Lot no,
MFG and Exp date, Amount of
the product with the problem,
Detailed description of the
complaint
A toll-free number,
E-mails, P.O boxes,
chat rooms

15. TECHNICAL INVESTIGATION
After receiving a complaint and investigation form QA
department starts an investigation.
There are two phases of technical investigation:-
1. Documentation-based investigation.
2. Laboratory analysis.

16. QA OFFICER
LABORATORY ANALYSIS
• Analyze complained
sample and retained
sample.
• The result will be
sent to the QA
complaint officer.
DOCUMENTATION
BASED
• Check previous files
for complaints of the
same nature.
• Check batch record
CONFIRMED
COMPLAINTS
NON - CONFIRMED
COMPLAINTS
The conclusion will be provided after the
investigation.
COUNTERFIT/TAMPER
SUSPICION

17. CONFIRMED COMPLAINTS
When both complaint and
retained samples showed
results in compliance with
specifications or when only
the complaint sample showed
OOS results.
EXAMPLE
When one tablet is missing
from an intact blister in the
complaint sample but there is
no deviation/change in the
retained sample.
NON-CONFIRMED
COMPLAINTS
When both complaint and
retained samples showed
results in compliance with
specifications or when
only the complaint sample
showed OOS results.
EXAMPLE
Change in appearance of
tablets due to light,
humidity, or high-
temperature exposure.
COUNTERFIT/TAMPER
SUSPICION
When the retained sample is
within the specification but
the complaint sample is
clearly OOS with no reason
for that, such as a
counterfeit or tampered
drug product.
EXAMPLE
The colour of the product is
completely different from
the original product or any
type of mixing takes place.

18. Following Points Must Be Taken Care of At The Time of
Complaint Handling:-
 The complaint Officer must check whether the complaint
represents any serious and unexpected adverse drug
reactions or not.
 After the completion of the investigation, the investigation
form must be signed off by the complaint officer and the QA
manager.
 A suitable period of time for an investigation's conclusion is
30 days.

19. CORRECTIVE ACTIONS AND FEEDBACKS TO
CUSTOMERS
Corrective measures(ranging from simple and quick training to
selected employees to formal Corrective And Preventive
Actions, CAPA Handling) must be carried out for all complaints
that have been verified.
Representatives of QA, QC, Regulatory Affairs and Product
Management established the multidisciplinary team.

20. For non-confirmed complaints originating from misuse and
improper handling of products written response together
with scientific information on correct use and handling of
product is provided to the customer.
In order to provide feedback to the customer, the company
sent a written letter to the complainant in which the company
explain all the measures taken by them including the
investigation approach, and the results obtained.
Since the customer returned the goods (the "complaint
sample") to the business for investigation and a quality issue
was discovered, the consumer should also get a free
replacement product along with the response letter.

21. 4) MONTHLY REPORTS AND TREND
ANALYSIS
Monthly reports should be prepared in order to assess the quantity and kind of complaints
received, as well as to do a trend analysis of these complaints.
The following questions must be answered in the monthly reports:
1. How many complaints did the firm get within that time frame?
2. How many have been confirmed?
3. How many were unconfirmed or suspected of being counterfeit or tampered with?
 Graphic data display technologies are useful tools for data analysis and presentation.
 The report must be easily accessible, particularly during GMP inspections.

22. DOCUMENTATION OF FINAL PRODUCT
COMPLAINT REPORT