COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES,PRODUCT RECALL,RETENTION RECORDS, DISTRIBUTION RECORDS.prepared by s.susena.

1. COMPLAINT HANDLING IN PHARMACEUTICAL
COMPANIES,
PRODUCT RECALL,RETENTION
RECORDS, DISTRIBUTION RECORDS
PREPARED BY
S.SUSENA,
SSJ COLLEGE OF PHARMACY,
M.PHARMACY(P.ANALYSIS&QA)

2. DISTRIBUTION RECORDS
INTRODUCTION
Distribution records are written data related to distribution of drugs(s)
from manufacturer to distributors. They are one of the most important records
required by GMP regulations. These records should be maintained in such a way
that a batch related distribution records is easily available.
OBJECTIVE
The objective of this guideline is that if there is some adverse drug
reaction or some quality defect, the manufacturer should be able to recall the
batch of a drug promptly . The information contained in these records is a key for
notification of customers in the event of a product recall.

3. CONTENTS OF RECORD
Product Information Describe the product being transfer to a new
owner (e.g. drug name, manufacturer, lot
number, strength, dosage form).
Transaction Information Describe the sale, transfer, return or other
disposition of the product (e.g. quantity, invoice
number, invoice date).
Distribution Information Describe the party selling or transferring owner
ship of the product (e.g. business name, name
and signature of person).
Recipient Information Describe the party receiving the product (e.g.
business name and address, date received,
name and signature of the person).

4. DOCUMENTATION
Distribution records include a wide range of documentation such as
invoices, bills of lading, customer‟s receipts, and internal warehouse storage
and inventory records.
EXAMPLE
Lot # 132A Product 500 mg. Aspirin tablets
Quantity Produced: 500 cases of 12 bottles of 100 tablets
Quantity
Shipper
Customer Date
Shipped
Initials
50 cases ACME Drug
Denver, CO
10/05/08 JS
40 cases ABC Medical
St. Louis, MO
10/09/08 SL
150 cases XYZ INC
Cleveland, OH
11/02/09 MJ

5. COMPLAINT HANDLING IN
PHARMACEUTICAL
COMPANIES

6. INTRODUCTION
A „Complaint‟ simply designates, that something is wrong or not good
enough. Generally in the pharmaceutical industry, complaints are regarding the
quality of drug product. A complaint shows customer dissatisfaction about a product
and consequently, about a company.
OBJECTIVE
To immediately recall, investigate or to take remedial measures against the
defective product.
TYPES
Basically it‟s of three types: -
1. Quality complaints: Originate at consumer level and concern with physical,
chemical and biological properties or condition of labeling and /or packaging of
the product.
2. Adverse reaction complaints: Due to allergic reactions of any other untoward
reaction or fatal reaction or near fatal reaction.
3. Other medically related complaints: Include complaints such as lack of efficacy or
clinical response.

7. GUIDELINES FOR HANDLING COMPLAINTS
 Don‟t take it personally
 Never act on a complaint without hearing (at least) two sides to the story
 Say what you will do and do what you say; set the time frame
 Keep notes
 Trust your instincts
CONTENTS OF A PRODUCT COMPLAINT DATA SHEET
 Serial number assigned to the complaints
 Exact nature of the complaints
 Name of the complainants
 Address of the complainants
 Date of complaint received
 Name of the product, strength & batch number of the product
 Quantity involved in the complaint
 Size of the sample obtained from the complainant
 Evaluation of compliant by Q.C department
 Name and signature of the investigator(s) & date
 Action taken by the company
 Copy of reply sent to complainant

8. STEPS INVOLVED IN HANDLING OF COMPLAINTS
Step 1: Receiving Complaints
It is important to have open channels 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. Whatever the channel, it is
necessary to have a person in charge of receiving the complaints and inputting
them into an appropriate investigation form that shall be addressed to the Quality
Assurance (QA) unit for investigation.
Step 2: Technical Investigation
Upon receipt of the investigation form, the QA unit is able to start the
investigation, which can be divided in two phases: documentation-based and
laboratory analysis.
 Documentation-based investigation - Consists of checking if this complaint
occurred previously in the same lot or if any nonconformance was found in the
lot during its production that could explain the complaint. The primary
documentation to be reviewed in this step consists of the complaint files and the
batch records.

9.  Laboratory analysis phase - Consists of requesting the Quality Control (QC)
laboratory to analyze both complaint samples and retained samples – the reserve
samples representative of the lot manufactured.
If the customer did not send the complaint sample for analysis, the
laboratory investigation will be carried out only with retained samples. Similar to
the receiving step, it is fundamental that the company elects a person in the QA
unit to be in charge of technical investigation of each complaint, e.g. a Complaint
Officer.
After receiving the analytical results, there are three possible conclusions,
as follows:
 Confirmed complaint - When both complaint and retained samples showed out-
of-specification (OOS) results or when only the complaint sample showed OOS
results, it is clearly a single unexplained failing product.
 Non-confirmed complaint - When both complaint and retained samples showed
results in compliance with specifications or when only the complaint sample
showed OOS results that cannot be considered a single unexplained failing
product. OOS results in a complaint sample can be attributed to misuse or
mishandling.

10.  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.
Step 3: 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. The criteria for
choosing appropriate action depends on the nature of the complaint, and the
complaint incidence. If a CAPA is opened, a multidisciplinary team consisting of
representatives of QA, QC, Regulatory Affairs and Production Management must be
established.
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.

11. Concerning non-confirmed complaints originating from misuse or
inadequate handling of the drug product, even if there is no need for internal
corrective actions, corrective measures should be implemented to provide orientation
to the customer.
Regarding counterfeit or tampered suspicious complaints, a response letter
should also be sent to the customer, but the Legal Affairs unit must be copied for
further arrangements.
Step 4: 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.

12. RECORDING OF COMPLAINTS
It is the responsibility of the in-charge, Quality control to see that each
complaint is recorded, evaluated and reported to the management. Records of
complaints should include the following information:-
1. Contents of complaints - These should include: -
 Name, dosage form, package form, batch no.
 Date and the place of occurrence of complaint
 Cause of complaint
 Name and address of complaint in detail
2. Results of investigation - These should include: -
 Result of investigation regarding market place, circulation condition and
condition in which the defect was observed
 Results of investigation of analysis and testing records, production and
storage records
3. Evaluation
4. Follow up measures - It includes:-
 Reply to the complainant
 Remedial action so that complaint of this type should not recur.

13. DOCUMENTATION OF 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.
___________________
 Expiry date ______________________ Quantity involved _____________
 Total quantity shipped __________________________
 Reason for complaint return request ___________________________________
 Complaint# _______________________ Product ______________________
 Evaluation of complaints
1. Physical characteristics _____________________________
2. Sign of deterioration _______________________________
3. Other observation _________________________________

14.  Quality control findings
1. Returned sample __________________________________
2. Returned sample re-assay ___________________________
3. Initial data _______________________________________
4. Quality control comments & suggestions
_________________________________________________________
_________________________________________________________
 Quality control ________________ Date ___________________
 Complaint# ____________________________________________________
 Product ______________________________________________________
 Packaging/Labeling/Inserts
Evaluation_____________________________________________________
_____________________________________________________________
_____________________________________________________________
 Remarks ______________________________________________________
______________________________________________________________

15.  Resultant action taken
1. Method, Date of customer notification & authorized action ___________
_________________________________________________________
_________________________________________________________
_________________________________________________________
2. Comments ________________________________________________
_________________________________________________________
_________________________________________________________
3. Completion date for action taken ______________________________
4. Quality assurance evaluation
_________________________________________________________
_________________________________________________________
_________________________________________________________

16. Customer complaint record book
Report
No.
Date
receive
d
Produ
ct
name
Receiv
ed by
Produ
ct lot
No.
Date
investiga
tion
started
Date
investiga
tion
ended

17. PRODUCT RECALL

18. DEFINITION
“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.
RECALL CLASSIFICATION
FDA classified the product recall depending on the health hazard caused
by the product in the following way:
1. Class I Recall- 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 Recall- A situation in which use of, or exposure to, a violative product
may cause temporary or medically reversible adverse health consequences or
where the probability of serious adverse health consequences is remote.
3. Class III Recall- A situation in which use of, or exposure to, a violative product is
not likely to cause adverse health consequences.

19. 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.
RECALL STRATEGY
A planned specific action to be taken in conducting a specific recall, which
addresses the depth of a recall need for public warnings and extent of
effectiveness checks for the recall.
Elements of a recall strategy
1. Depth of recall: Depending on the product‟s degree of hazard and extent of
distribution, the recall strategy will specify the level in the distribution chain to
which the recall is to extend.

20. 2. Public warning: The purpose of a public warning is to alert the public that a
product being recalled presents a serious hazard to health.
3. Effectiveness checks:
The purpose of effectiveness checks is to verify that all consignees at the
recall depth specified by the strategy have received notification about the recall
and have taken appropriate action. The recall strategy will specify the method(s)
to be used for and the level of effectiveness checks that will be conducted, as
follows:
 Level A - 100 percent of the total number of consignees to be contacted;
 Level B - Some percentage of the total number of consignees to be
contacted, but is 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.

21. RECALL NUMBER
Number is assigned by a responsible centre for each recalled product. This
number consists first a letter designating the responsible centre, a 3 or 4 digit
sequential number indicating the number of recall initiated by that centre during the
fiscal year, and a 4 digit number indicating the fiscal year the recall was initiated.
F-100-2010 identifies the 100th recall initiated by the Centre for Food Safety
and Applied Nutrition (CFSAN) in FY-2010.
Letter Centre/Office
F Foods-CFSAN
D Drugs-Centre for Drug Evaluation and Research (CDER)
Z Medical Devices & Radiological Health-CDRH
V Veterinary Medicine- Centre for Veterinary Medicine (CVM)
B Biologics-Centre for Biologics Evaluation and Research (CBER)
N Medical Devices (Voluntary Safety Alerts and Notifications)
A
Audit Numbers issued by the District performing the recall, the Centres, Office
of Enforcement Division of Compliance Management and Operations
[DCMO], or the Division of Field Investigation [DFI] to monitor recalls requiring
audit checks.

22. RECALL TEAM
The Team is responsible for co-ordinating all aspects of the product recall.
A recall coordinator, is to be appointed and members of a recall team identified from
the various functional areas. Together the team will assist the Recall Coordinator in
the event of the recall.
The Recall Management Team list shall be updated at least four times a
year to ensure all names, contact phone numbers and responsibilities of team
members and alternates are updated.
Name
Alternate
person
Business
phone
After hours
phone
Responsibilities during
recall
Chief
Executive
Officer
Production
Manager
 Decision making
 Media communication
 Contacting accounts
 CFIA/Health
departments contact
 Obtaining legal counsel
Q.A Manager
Production
Manager
 Q.A/Technical advisory
 Complaint investigation
 DFIA/Health
departments contact

23. LIST OF FORMS REQUIRED FOR THE RECALL
 Notification of Withdrawal
 Notification of Recall
 Recall Log
 Problem Report
 QA Incident Hold Form
 Receiving Log
 Shipping Log
 Recipe(s)
RECALL PROCEDURE
It basically involves three steps:
1. Recall Notification / Inspection – If FDA identifies that a potentially violative
product which may lead/has lead to a class I or significant class II recall, an
inspection should be made to determine the root cause(s) of the problem(s).
2. Inspection Procedures – An important part of your job is to identify the root
cause for the recall and assure the firm has implemented procedures to prevent
it from recurring.

24. 3. Recall Decision Follow-up – If the firm has decided to recall, do the following:
 Request that management obtain their FDA District‟s review of recall
correspondence.
 If the firm requests guidance in preparing recall communications, provide it in
accordance with your District policy.
 Obtain an Official Sample of the recalled product.
 Obtain a complete distribution list of all shipment(s) of the suspect lot(S),
including foreign distribution.
 Advise the firm on how the returned products should be handled.
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.

25. PRODUCT RECALL CHART
Assemble the Recall Management Team (CEO),
(QA Manager), (Plant Manager), (Purchasing Manager)
Notify the CFIA / Other Health Agencies
Identify all products to be recalled
Detain and Segregate all products to be
recalled which are in the firm‟s control
Prepare the Press Release (if required)
Prepare the Distribution List
Prepare and distribute the Notice of Recall
Verify the effectiveness of the recall
Control the recalled product (s)
Decide what to do with the recalled product (s)
Fix the cause of the recall if the problem occurred at your facility

26. 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

27. INDIAN PHARMACEUTICALS LIMITED
MEDICINE RECALL OR WITHDRAWAL PROCEDURES
Press statement:
Issued by:
Date:
Time:
INDIAN PHARMACEUTICALS LIMITED, a pharmaceutical company wishes to
advise a single batch.
Number ___________________________ of ___________________ has been
__________________________________________________________ in patients
were _________________ a serious risk may exist. Patients in possession of this
particular batch number are requested to refrain from using it.
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
____

28. 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
Fax
Letter
Telex
Telegram
T.V
Radio
Press

29. RETENTION OF RECORDS
Organizations create records through daily business transactions. These records
are considered active for as long as they are needed to be easily accessible for the
organization to use to perform its current functions.
Once a record is no longer useful for performing current activities, it
becomes inactive. But it must be kept, or “retained,” as long as it is needed to meet
the organization‟s administrative, fiscal, legal, or historical requirements. The length
of time the record must be kept to meet those requirements is referred to as its
retention period.
As records grow at an excessive rate and cost the organization resources
for its maintenance and storage (regardless of the format), they must be disposed
of at the end of their retention period.
Disposition is a final administrative action taken with regard to records,
and may include destroying them transferring them to another entity, or preserving
them permanently. During the disposition process, records are approved for
destruction or other disposition according to the policies and procedures of the
program.

30. REFERENCES
1. DISTRIBUTION RECORDS
 Pg: 180-181 of Q.A Manual by D.H Shah
 Pg: 530 of How to practice GMP‟s by P.P Sharma
 http://www.gmp7.com/guidefordocumentationandrecords_cm350.html
 http://www.enkap.org/docs/subpartj_excerpt_may.pdf
 http://www.authorstream.com/Presentation/cs_apc_09-993865-distribution-
cs-ppt/

31. 2. COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES
 Pg: 114 of How to practice GMP‟s by P.P Sharma
 Pg: 590 of cGMP for Pharmaceuticals by Manohar A. Potdar
 Pg: 181; 266 of Q.A Manual by D.H Shah
 http://www.slideshare.net/husna05/complaints-and-recall-handling
 http://onlinelibrary.wiley.com/doi/10.1002/qaj.398/pdf
3. PRODUCT RECALL
 Pg: 131; 595 of cGMP for Pharmaceuticals by Manohar A. Potdar
 Pg: 116 of How to practice GMP‟s by P.P Sharma
 Pg: 154; 266 of Q.A Manual by D.H Shah
 http://www.fda.gov/drugs/drugsafety/DrugRecalls/default.htm
 http://en.wikipedia.org/wiki/Product_recall
4. RETENTION RECORDS
 Pg: 177; 267 of Q.A Manual by D.H Shah
 http://www.arma.org/rim/101/articles.cfm?key=rim101retention
 http://www.cpa.net/resources/retengde.pdf