Seminar on

Handling Of Returned Goods Recovered

materials and reprocessing & COMPLAINTS
AND RECALLS.

Presented By,
APARNA.CHALLURI
Reg.no: 11FJ1SO402
Under the guidance of,
Mrs. NANSRI SAHA
Dept of Pharmaceutics

HANDLING OF RETURNED GOODS

RECOVERED MATERIALS AND
REPROCESSING
RETURNED GOODS:
Pharmaceutical products can be returned from market for

various reasons e.g. Quality problems , accidental damage

of goods etc.
such products when returned from market should have
the following action immediately taken on it.
i.Physically examine the condition of the goods returned.
Also check all the relevant documents.
ii.Ask Q.C. department to evaluate the quality of the goods
received and take a decision on whether these products
can be reprocessed ,recovered or needs to be destroyed.
2

iii. If it possible to reprocess and recover, then such

products after reprocessing or retesting may be
considered for relabeling , repacking and reselling the
same.
iv. Q.C. department should evaluate all aspects of the

received material.
v. Where even a slightest doubt arises about the

quality of the product , it should not be considered

suitable for reissue or reuse.
vi. Any action taken should be recorded.

Documents required:
. SOP on handling of returned goods
3

Recovered materials:
Recovered materials are defined as those materials
that have been diverted or removed from the solid
waste stream for sale, reuse or recycling,
whether or not they require subsequent separation
and processing
Recovering materials that would otherwise be
disposed of as waste is one way
to conserve resources. If done properly, it can benefit
the environment, conserve raw materials and reduce
energy.
4

The addition of all or part of earlier batches , conforming to

the required quality , into a batch of same product at pre

defined stage of manufacture should be authorized before
hand.
The recovery should be carried out in accordance with a

defined procedure after evaluation of risks involved,

including any possible effect on shelf life.
The recovery should be recorded.
Normally 5 to 10 % of recovery can be added into fresh

batch, provided the recovered material is meeting the

specifications.
Such additions must be properly authorized and recorded.
5

REPROCESSING :
Rejected production batches should be

reprocessed in exceptional situations.

Such reprocessing should be permitted only if
the reprocessed batch is going to meet the same
specification after reprocessing
A detailed record of such reprocessing should be
kept.
Reprocessed batches should be given by means
of which, such batches can be identified as
reprocessed batches.
Such batches should be separately monitored
through out their shelf life.
6

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.

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.

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).

Receiving the complaints/ verbal

10

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.
11

PRODUCT NAME

COMPLAINT CATEGORY

Batch no. Mfg.date expiry

date
Name / address of the
complainant:
Complaint
reported
through:
Complainant
sample
enclosed: yes / no
Quality
of
sample
enclosed:
Investigation report

Packaging/
medical.

product

quality/

Total quantity involved

PCR received by
On:
Investigation done by:

Action taken

recommended

Conclusion:
Confirmed/not confirmed
PCR no:
PCR approved by:
corrective

12

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.
13

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.
14

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.

15

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.
16

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.
17

customer
Make a complaint
through toll free no.,
E-mails, P.O. Box

Company's
contact
person

QA complaint
officer

Open
Open the
the investigation,
investigation,
including
including information
information about
about
the
the customer
customer and
and about
about the
the
complaint(product
complaint(product name,
name, lot
lot
no.,
no., mfg
mfg &
& expiry
expiry date
date and
and
complaint
complaint description.)
description.)
Ask
Ask the
the customer
customer to
to return
return
the
the product
product for
for analysis.
analysis.
18

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.
19

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.
20

Laboratory analysis
Documentation
Analyze complained
based
sample and retained
Check complaint
sample.
files for previous
Send results to QA
complaints of same
complaint officer
nature.
Check batch
ON DOC.COMPLAINTS
REVIEW
& LAB ANALYSIS , HE FINISHES IN
CONFIRMED
QA BASED
COMPLAINT
OFFICER
records.

21

 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.
22

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.
23

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.

24

 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.

25

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

26

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.
27

FEED
BACK
RESPONSE
LETTER
TO CUSTOMER
CORRECTIVE
ACTIONS
STEPTO4:CUSTOMERS
MONTHLYWRITE
REPORTS
AND
TREND
ANALYSIS

28

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.
29

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--------------------30

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-------------------------------------

31

4.Quality control comments & suggestions

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Quality control-------------------,Date-------------------Complaint#____________________________________
Product_______________________________________
Packaging/Labeling/Inserts
evaluation_____________________________________________
________________________________________________________
__________________________
Remarks_______________________________________________
____________________________________
32

Resultant action taken:

1.Method,Date of customer notification &
authorized
action_____________________________________________
________________________________________
2.Comments______________________________________
___________________________________________________
____________________________________
3.Completion date for action taken
_______________

4.Quality assurance evaluation

___________________________________________________
___________________________________________________
_________________________
33

Customer complaint record book

Repo Date
rt no. recei
ved

Produ Recei Produ Date

ct
ved
ct lot inves
name by
no.
tigati
on
start
ed

Date
inves
tigati
on
ende
d

34

RECALL HANDLING
Recall means a firms 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.
35

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
36

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.
37

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:
__________________________________________________
38

 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)
__________________________________________________
39

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
and submitsQUANTITY
a copy for verification
NAME
OFdays
QUANTITY
QUANTITY
of the success
of recall. RETURNED ACCOUNTE
THE
DISTRIBUT
DISTRIBUT ED
D
ED

TOTAL
40

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.
41

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.
42

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,
G.M. QA/QC Regulatory
43

 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.
44

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.
45

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.
46

NAME

Chief Executive
Officer

ALTERNATE
PERSON

Production
Manager

BUSINESS PHONE

AFTER HOURS
PHONE

RESPONSIBILITIE
S DURING
RECALL

Quality
Assurance
Manager

Production
Manager

Decision
Making
Media
Communicati
on
Contacting
Accounts
CFIA,/
Health
Departments
Contact
Obtaining
Legal
Counsel
Quality
Assurance /
Technical
Advisory
Complaint
Investigation
47

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.

48

 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.
49

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. FDAs written notice to the
regulatee is the real termination.

50

PRODUCT RECALL CHART

Assemble the recall management team

Contd .
51

Prepare and distribute the notice of recall

52

References
1.Us53 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=RE
CALL+MANUAL&pbx=1&oq=RECALL+MANUAL&aq=f&aqi=g2gv2gm1&aql=&gs_sm=e&gs_upl=30014l34331l0l35759l13l12l0l0l0l0
l1466l12191l64.7l11l0&bav=on.2,or.r_gc.r_pw.&fp=259c071b4fb78fb5&biw=1
358&bih=566)
53

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
54
11.www.photobucket.com

Conclusion:
I here by conclude that , all
complaints and recalls and other information
concerning potentially defective products must
be carefully reviewed according to written
procedures and corrective action should be
taken, it gives the company an opportunity to
improve the quality of the product and afford
better protection for consumers.

55

56