COMPLAINTS AND

RECALLS HANDLING.
PRESENTED BY,
HUSNA KANWAL QURESHI.
M.Pharm, 1st yr, 2nd sem.
UNDER THE GUIDANCE OF
Dr. T. MAMATHA M.Pharm, Ph.D.
QUALITY ASSURANCE.

1
 COMPLAINT HANDLING
DEFINATION OF COMPLAINT:
• “Complaint is defined as statement that is
something wrong or not good enough, which
shows customer dissatisfaction about the
company and the product”.
Example: Complaint about packaging materials,
Concerning about the product etc.

2
NEED FOR COMPLAINT HANDLING
SYSTEM
• It gives the company an opportunity to
improve the quality of the product
• It is helpful to maintain cGMP
• It maintains committed relationship between
the customer and company
• It is the regulatory obligation.

3
 SOP on complaint handling
• OBJECTIVE: To lay out the procedure for investigation
and reporting the market complaints.
• RESPONSIBILITY: The quality assurance manager along
with manager of the complaint related department.
PROCEDURE:
• Complaints shall be classified in following
categories to facilitate investigation:
• Product quality complaints (non therapeutic).
• Packaging complaints (shortages and packaging error).
• Medical complaints (therapeutic problems).
4
5
Time period for investigation after receipt of
complaints:
• Product quality complaints – within 5 days.
• Packaging and quality complaints – within 10
days.
• Medical complaint – within 3 days.
Complaint records shall be maintained at least
one year after expiration date of medicines.
Complaint records shall be reviewed and a
monthly summary shall be prepared for the
management.
6
PRODUCT NAME COMPLAINT CATEGORY
Batch no. Mfg.date expiry date Packaging/ product quality/ medical.
Packaging details:
Name / address of the
complainant:
Complaint reported through:
Complainant sample enclosed: Total quantity involved
yes / no
Quality of sample enclosed:
PCR received by
Investigation report
On:
Investigation done by:
Action taken Conclusion:
Confirmed/not confirmed
PCR no:
PCR approved by:
recommended corrective actions
7
 Product complaint data sheet
Product complaint data sheet should have the
following details:
• Serial number assigned to the complaints.
• Exact nature of the complaints.
• Name of the complainants.
• Address of the complainants.
• Date of complaint received.
• If verbal, name of the person who received the
complaint.
• Name of the product, strength and batch number of
the product.
• Reference to analytical record number.
8
• Quantity involved in the complaint.
• Size of sample obtained from the complainant.
• Evaluation of complaint by QC department.
• Materials and records used to perform evaluation.
• Other possible effected materials, products and
results of their investigation.
• Name and signature of the investigator(s) and date.
• Action taken by the company.
• Copy of reply sent to complainant.

9
 Steps in handling of complaints
The proposed handling system is in
compliance with the GMP Guidelines of EU,
USA and Brazil and is presented in four steps:
1.Receiving complaints.
2.Technical investigation.
3.Corrective actions/feedback to
Customers.
4. Monthly reports/trend analysis.
10
 Receiving complaints
It is important to have open channels with with
customers in order to receive their suggestions,
doubts and complaints. Generally, these
channels are toll-free numbers, e-mails, chat-
rooms and P.O. boxes.
• The most flexible channels are toll-free
numbers and chat-rooms.
• A person must be appointed in charge of
receiving complaints and inputting them into
appropriate investigation form that shall be
addressed. 11
 The investigation form must include:
• Information about the complainant:
- Name
- Address
- phone no.
- E mail
• Information about the drug product
- Product name
- Lot no
- MFG & Exp date
- Amount of the product with the problem.
- Detailed description of the complaint.
12
 customer
Make a complaint through
toll free no., E-mails, P.O.
Box

Company's
contact person •Open the investigation, including
information about the customer and
about the complaint(product name,
lot no., mfg & expiry date and
QA complaint description.)
complaint •Ask the customer to return the
product for analysis.
officer
13
 Technical investigation
 Upon receipt of the investigation form, the QA unit is
able to start the investigation.
It is divided into two phases:
• Documentation based investigation.
• Laboratory analysis.
Documentation based investigation:
The primary documentation to be reviewed consists of:
 Complaint files: This is constituted to check how many
other complaints of the same nature had occurred to a
specific lot and how they were handled.
 Batch records must be verified in order to see if there
were any non-conformance during the production. 14
 Laboratory analysis phase
 It consists of requesting the Quality Control (QC)
laboratory to analyze.
• Complaint samples.
• Retained samples.
Complaint samples are the customer sample.
Retained samples – the reserve samples representative
of the lot manufactured (which were kept under
appropriate conditions of temperature, humidity and
light so that the drug product was not affected).
 The company elects a person in the QA unit to be in
charge of technical investigation of each complaint,
e.g. a Complaint Officer. 15
Documentation based
•Check complaint files for
previous complaints of
same nature.
•Check batch records.

16
 There are three possible conclusions, as follows:
• Confirmed complaints.
• Non confirmed complaints.
• Counterfeit/ tamper suspicion.
CONFIRMED COMPLAINTS:
• When both complaint and retained samples showed out-
of-specification (OOS) results or when only the complaint
sample showed OOS results.
Example:
• a single unexplained failure may be when one tablet is
missing in the intact blister strip in the complaint sample,
but no deviation was found in the retained samples or
during the in-process controls and final QC analysis
recorded in the batch record.
17
NON-CONFIRMED COMPLAINTS:
• When both complaint and retained samples showed
results in compliance with specifications or when only
the complaint sample showed OOS results.
• OOS results in a complaint sample can be attributed to
misuse or mishandling, when the drug product was not
kept under appropriate conditions of temperature,
humidity and light so that the identity, strength, quality
and purity of the drug product could be affected.
Example:
Tablets of the complaint sample show a change in
their appearance that is characteristic of a light,
humidity or high temperature exposure.
18
COUNTERFEIT / 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:
• when packaging material is different from the
original; an example of tampering is when the
color of the drug product is completely different
from the original or when any foreign substance
was added to the product.
19
 The Complaint Officer must also check if the
complaint represents a serious and
unexpected adverse drug experience.
 The Complaint Officer and the QA Manager
must sign off the investigation form once the
investigation is completed.
 30 days is a reasonable time to conclude an
investigation.
 Complaint files should be retained for at least
1 year after the expiry date of the lot.

20
CORRECTIVE ACTIONS AND FEEDBACK
TO CUSTOMERS
 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 Action (CAPA) handling.
• If a CAPA is opened, a multidisciplinary team consisting of
representatives of QA, QC, Regulatory Affairs and
Production Management must be established.
 Concerning non-confirmed complaints originating from
misuse or inadequate handling of the drug product. The
customer should receive a written response together with
scientific information on the correct use and handling.
Contd … 21
As feedback to the customer, the company must
write a response letter to the complainant to
explain the investigation approach taken, the
results obtained and any implications, in case the
quality problem was confirmed.
The customer should be sent a free replacement
product together with the response letter, since
the customer returned the product (the
‘complaint sample’) to the company for analysis
and a quality problem was found.

22
23
 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.
The monthly reports must answer the following questions:
 How many complaints did the company receive in the period?
 How many were confirmed?
 How many were non-confirmed or were counterfeit/tamper
suspicion?
• Graphic methods of displaying data are important adjuncts to
data analysis and presentation.
• The report must be readily available mainly during GMP
inspections.
24
 Documentation final product
complaint report
• Nature of the complaint--------------------------
• Date------------------
• Complaint:-------------------------
• Originator of the complaint & title ----------------------------
• Distribution contact person & title ----------------------------
• Method of notification----------------------------
• Name------------------------------------------------------
• Phone No.------------------------------ P.O#--------
• Date shipped-------------Invoice#-------
• Product name:----------------- Control no:----------
• EXP date:---------------- Quantity involved---------------------
25
• Total quantity shipped----------------------------------------
• Reason for complaint return request--------------------------
• Complaint#------------ Product--------------------
• Evaluation of complaints:
1.Physical characteristics-------------------------
2.Sign of deterioration ----------------------------
3.Other observation--------------------------------
• Quality control Findings:
1.Returned sample--------------------------
2.Returned sample re assay---------------
3. initial data-------------------------------------

26
• 4.Quality control comments & suggestions
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
---------------------------------------------------------------------
• Quality control-------------------,Date--------------------
• Complaint#____________________________________
• Product_______________________________________
• Packaging/Labeling/Inserts
evaluation________________________________________
________________________________________________
_______________________________________
• Remarks_________________________________________
__________________________________________
27
Resultant action taken:
• 1.Method,Date of customer notification & authorized
action_________________________________________
____________________________________________
• 2.Comments____________________________________
______________________________________________
___________________________________________
• 3.Completion date for action taken _______________
• 4.Quality assurance evaluation
______________________________________________
______________________________________________
___________________________________

28
 Customer complaint record book
Report Date Product Receive Product Date Date
no. receive name d by lot no. investig investig
d ation ation
started ended

29
 RECALL HANDLING
 ‘‘Recall’’ means a firm’s removal or correction of a marketed
product that the Food and Drug Administration considers to
be in violation of the laws it administers and against which
the agency would initiate legal action, e.g., seizure.
The main objectives of this recall plan are:
• Stop the distribution and sale of the affected product.
• Effectively notify Management, customers and regulatory
authority.
• Efficiently remove the affected product from the
marketplace, warehouse and/or distribution areas.
• Dispose and Conduct a root cause analysis and report the
effectiveness and outcome of the recall.
• Implement a corrective action plan to prevent another recall.30
 SOP on recall
• RESPONSIBILITY:
 General manager / vice president: (QA/QC, Regulatory)
• General Manager: manufacturing.
 In case of adverse event a committee evaluates the crisis. It
consists of following individuals:
• GM/V.P/QA/QC, Regulatory
• GM Manufacturing
• GM, Formulation and Development
• Medical advisor
• Vice president - Marketing
• Vice president – International Marketing
• Vice president – Technical Operations
31
PROCEDURE:
 Any employee becoming aware of such medicine should
immediately notify to higher authorities.
 Immediately quarantine existing in-house of relevant
medicine. Record the following information:
a) The product name, strength, packs size, batch no., mfg and
expiry date.
b) The total number of units released for sale.
c) Date on which distribution commenced.
d) Total number of units distributed.
e) Number of units still in stock.
f) Nature of reported violation.
 In the light of above information higher officials evaluates the
health hazard presented by the violation medicine and
documents it on “ medicine recall control document”. 32
 INDIAN PHARMACEUTICALS LIMITED
Medicine recall control document
• Product information:
1. Manufacturer ---------------------------------------------------------------
2. Product name---------------------------------------------------------------
3. Strength-----------------------------------------------------------------------
4. Pack size--------------------------------------------------------------------
5. batch number ---------------------------------------------------------------
6. total number of units originally released for sale: _________
7. Date of which distribution commenced: ______________
8. Total number of units distributed: _____________________
9. Number of units still in stock:
• At factory
• With stockiest (s)
10. The nature of the reported violation:
__________________________________________________ 33
 Formulating a proposed recall strategy. It specifies the nature
of communication to be used (phone, fax, telegram, letters,
telemail, etc) as well as the level in the distribution chain to
which recall is extended.(wholesalers, retailers, public, etc).
 Relevant records shall be submitted to regulatory authorities
with proposed plan of action.
INDIAN PHARMACEUTICALS LIMITED
Medicine recall control document
3. RECALL STRATEGY
3.1. Nature of communication (phone, fax, telegraphs, letters,
news papers, etc.)
__________________________________________________
__________________________________________________
Depth of recall: (Wholesalers, retailers, general public)
__________________________________________________
34
 The GM, QA/QC Regulatory or GM manufacturing
implements recall without delay.
 They also prepare an interim reconciliation report after 30
days and submit a copy to concerned authorities.
 After that prepares a final reconciliation report after 90
days and submits a copy for verification of the success of
recall.

35
• Signature of GM, QA/QC Regulatory G.M. manufacturing
should be taken.
• Steps should betaken to prevent the re-occurrence.
 Prior to completion of recall the following points should be
considered:
• Method of destruction of the product .
• A designed area to receive returned medicines.
• Inventory of medicine.
• Destruction authorization.
 The recall will be terminated when the GM, QA/QC
Regulatory or GM manufacturing are assured that recall
has been completed reasonably and a “medicine record
status report” is completed.
36
 INDIAN PHARMACEUTICALS LIMITED
MEDICINE RECALL OR WITHDRAWAL, PROCEDURE STATUS REPORT
Date: ________ product: ___________ Strength:____________
Pack size: ____________ B.no: _________Exp.date: ________
Nature of defect: ____________________________________
Reason for recall: _____________________________________
Indication of health risk or any other reason: ________________
Reported clinical problems: ______________________________
Method of communication to users:
Method Action Date Target Group Number
• Phone
• Letter
• Telegram
• TV
• Radio, Press etc.
37
 GM, QA/QC Regulatory or GM manufacturing shall
prepare a “ Standardized recall letter” and “press
statement”.
INDIAN PHARMACEUTICALS LIMITED
STANDARD RECALL LETTER
Dear customer:
It has come to our notice (product name) _______________
having batch number ______________ or has shown ________
please refrain from prescribing or dispensing any of this batch
number and return all your stock of this batch number to our
office at: __________________________________________
All returned stock or this batch number will be replaced as
free of charge. We apologies for any inconvenience caused to
you and thank you for your co-operation.
Yours faithfully,
38
G.M. QA/QC Regulatory
 After the authorization by GM, QA/QC Regulatory or GM
manufacturing, the recalled material along with stock in hand
shall be destroyed and that should be recorded.
RECALL CLASSIFICATION:
FDA classified the product recall depending on the health hazard
caused by the product .
(1)Class I is a situation in which there is a reasonable probability
that the use of, or exposure to, a violative product will cause
serious adverse health consequences or death.
(2)Class II is a situation in which use of, or exposure to, a
violative product may cause temporary or medically
reversible adverse health consequences.
(3)Class III is a situation in which use of, or exposure to, a
violative product is not likely to cause adverse health
consequences.
39
RECALL POLICY:
• Recall is an effective method of removing or correcting
consumer products that are in violation of laws
administered by the FDA.
• Recall may be undertaken voluntarily and at any time by
manufacturers and distributors, or at the request of FDA.
• Recall is generally more appropriate and affords better
protection for consumers. Seizure, multiple seizure, or
other court action is indicated when a firm refuses to
undertake a recall requested by the Food and Drug
Administration.

40
HEALTH HAZARD EVALUATION:
• An evaluation of the health hazard presented by a product
being recalled or considered for recall will be conducted by an
ad hoc committee of Food and Drug Administration.
• It involves the assessment of hazards to various segments of
the population, degree of seriousness, likelihood of
occurrence, consequences etc.
RECALL TEAM:
• A recall coordinator is to be appointed and members of a
recall team identified from the various functional areas.
• All members must ensure that all procedures are carried out
effectively and efficiently. The team should receive
appropriate training.
• The Recall Management Team list shall be updated at least
four times a year.
41
 NAME ALTERNATE BUSINESS AFTER HOURS RESPONSIBILITIE
PERSON PHONE PHONE S DURING
RECALL

Chief Production
Executive Manager • Decision
Officer Making
• Media
Communicat
ion
• Contacting
Accounts
• CFIA,/
Health
Department
s Contact
• Obtaining
Legal
Counsel

Quality Production  Quality

Assurance Manager Assurance /
Manager Technical
Advisory
 Complaint
Investigation
 CFIA /
Health
Department
s Contact
42
RECALL STRATEGY:
(1)A recall strategy that takes into account the following
factors :
(i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product's deficiency is obvious to
the consumer or user.
(iv) Degree to which the product remains unused in the
market-place.
(v) Continued availability of essential products.

43
 Elements of a recall strategy:
 Depth of recall.
 Public warning.
 Effectiveness checks:
• Level A--100 percent of the total number of consignees to be
contacted.
• Level B- greater that 10 percent and less than 100 percent of
the total number of consignees.
• Level C--10 percent of the total number of consignees to be
contacted.
• Level D--2 percent of the total number of consignees to be
contacted.
• Level E--No effectiveness checks.
44
• TERMINATION OF RECALL:
• A recall will be terminated when the FDA is
confident that product has been removed from
market in accordance with recall strategy. FDA’s
written notice to the regulatee is the real
termination.

45
PRODUCT RECALL CHART

Contd ….
46
47
 References
1.Us48 Food &drug administration.21 code of federal
regulation-part 211.198.
2. Current good manufacturing practices of
pharmaceuticals - Manohar . A . Potdar.
3. How to practice GMP By P.P. Sharma
4. Validation in pharmaceutical industry by P.P. Sharma.
5. Recall Manual
(http://www.google.co.in/#sclient=psy&hl=en&source=hp&q=RECALL
+MANUAL&pbx=1&oq=RECALL+MANUAL&aq=f&aqi=g2g-v2g-
m1&aql=&gs_sm=e&gs_upl=30014l34331l0l35759l13l12l0l0l0l0l1466
l12191l6-
4.7l11l0&bav=on.2,or.r_gc.r_pw.&fp=259c071b4fb78fb5&biw=1358&
bih=566)
48
 References
6. Complaint Handling in Pharmaceutical Companies
Glaucia Karime Braga*; Faculty of Pharmaceutical
Sciences, University of Sao Paulo, Brazil.
7. WHO technical reports series, No. 908, 2011.
8. Good Manufacturing Practices for pharmaceuticals –
A Plan for total Quality control from manufacture
to consumer 5th edition - Sidney H. Willig.
9. www.interscience.com
10. www.google .com
11.www.photobucket.com
49
50