1. Presented By,
APARNA.CHALLURI
Reg.no: 11FJ1SO402
Under the guidance of,
Mrs. NANSRI SAHA
Dept’ of Pharmaceutics
1

2. 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

3. 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

4. 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

5. 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

6. •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

7. 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.
7

8. 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.
8

9. 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).
9

10. Receiving the complaints/ verbal
Forwarding to heads of QA,QC dept.
Investigation of the complaints
Report(product, complainant, sample,
action taken etc. details)
Assigning a specific PCR number Ex:
PCR/001/11.
Recalls if any
Maintenance of register of
complaints.
10

11. 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

12. PRODUCT NAME COMPLAINT CATEGORY
Batch no. Mfg.date expiry date Packaging/ product quality/
medical.
Name / address of the
complainant:
Complaint reported through:
Complainant sample enclosed: Total quantity involved
yes / no
Quality of sample enclosed:
Investigation report PCR received by
On:
Investigation done by:
Action taken Conclusion:
Confirmed/not confirmed
PCR no:
PCR approved by:
recommended corrective
actions 12

13. 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

14.  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.
14

15. 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

16. 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

17.  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

18. 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
complaint description.)
QA complaint •Ask the customer to return the
officer product for analysis.
18

19. 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

20. 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

21. Documentation based Laboratory analysis
•Check complaint files •Analyze complained sample
for previous complaints and retained sample.
of same nature. •Send results to QA
•Check batch records. complaint officer
QA
COMPLAINT
OFFICER
BASED ON DOC.
REVIEW & LAB ANALYSIS
, HE FINISHES
INVESTIGATION AND
PROVIDES CONCLUSION
CONFIRMED NON- COUNTERFEIT
COMPLAINT CONFIRMED / TAMPER
S COMPLAINTS SUSPICION
21

22.  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

23. 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

24. 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

25.  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

26. 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

27. 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

28. CORRECTIVE ACTIONS
RANGE FROM QUICK FEED BACK TO CUSTOMERS WRITE
TRAINING TO CAPA RESPONSE LETTER TO CUSTOMER
HANDLING. DELIVER A FREE OFFER PRODUCT
STEP 4: MONTHLY REPORTS AND TREND ANALYSIS
QA COMPLAINT OFFICER EVALUATES MONTHLY REPORTS.
PARETO ANALYSIS FOR CONFIRMED COMPLAINTS
28

29. 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

30. 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

31.  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

32.  4.Quality control comments & suggestions -------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
-------
 Quality control-------------------,Date--------------------
 Complaint#____________________________________
 Product_______________________________________
 Packaging/Labeling/Inserts
evaluation_________________________________________
__________________________________________________
____________________________________
 Remarks___________________________________________
________________________________________
32

33. Resultant action taken:
 1.Method,Date of customer notification &
authorized
action_________________________________________
____________________________________________
 2.Comments____________________________________
_______________________________________________
__________________________________________
 3.Completion date for action taken
_______________
 4.Quality assurance evaluation
_______________________________________________
_______________________________________________
_________________________________
33

34. Customer complaint record book
Repor Date Produ Receiv Produ Date Date
t no. receive ct ed by ct lot investi investi
d name no. gation gation
started ended
34

35. 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.
35

36. 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

37. 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

38. 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

39.  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

40. 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.
NAME OF QUANTITY QUANTITY QUANTITY
THE DISTRIBUTE RETURNED ACCOUNTE
DISTRIBUTE D D
D
TOTAL
40

41.  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

42. 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

43. 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

44.  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

45. 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

46. 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

47. NAME ALTERNATE BUSINESS PHONE AFTER HOURS RESPONSIBILITIE
PERSON PHONE S DURING
RECALL
Chief Executive Production • Decision
Officer Manager Making
• Media
Communicati
on
• Contacting
Accounts
• CFIA,/
Health
Departments
Contact
• Obtaining
Legal
Counsel
Quality Production Quality
Assurance Manager Assurance /
Manager Technical
Advisory
Complaint
Investigation
CFIA /
Health
Departments
Contact
47

48. 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

49.  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

50.  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.
50

51. PRODUCT RECALL CHART
Assemble the recall
management team
Notify health agencies
Identify all products to be
recalled
Detain and segregate all products to be
recalled which are in the firms control
Prepare the
press release
Prepare the Contd ….
distribution list
51

52. Prepare and distribute
the notice of recall
Verify the effectiveness
of the recall
Control the recalled
products
Decide what to do with
the recalled product
Fix the cause of the
recall if the problem
occurred at your facility
52

53. 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=RECALL
+MANUAL&pbx=1&oq=RECALL+MANUAL&aq=f&aqi=g2g-v2g-
m1&aql=&gs_sm=e&gs_upl=30014l34331l0l35759l13l12l0l0l0l0l1466l12191
l6-
4.7l11l0&bav=on.2,or.r_gc.r_pw.&fp=259c071b4fb78fb5&biw=1358&bih=
566)
53

54. 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
54

55. 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. 56