Escolar Documentos
Profissional Documentos
Cultura Documentos
Presented By,
APARNA.CHALLURI
Reg.no: 11FJ1SO402
Under the guidance of,
Mrs. NANSRI SAHA
Dept of Pharmaceutics
received material.
v. Where even a slightest doubt arises about the
Documents required:
. SOP on handling of returned goods
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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.
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REPROCESSING :
Rejected production batches should be
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.
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PRODUCT NAME
COMPLAINT CATEGORY
Packaging/
medical.
product
quality/
Action taken
recommended
Conclusion:
Confirmed/not confirmed
PCR no:
PCR approved by:
corrective
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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.
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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.
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Receiving complaints
It is important to have open channels with
- 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.
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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.
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Technical investigation
Upon receipt of the investigation form, the QA unit is
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.
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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.
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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.
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FEED
BACK
RESPONSE
LETTER
TO CUSTOMER
CORRECTIVE
ACTIONS
STEPTO4:CUSTOMERS
MONTHLYWRITE
REPORTS
AND
TREND
ANALYSIS
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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
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-------------------------------------
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--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Quality control-------------------,Date-------------------Complaint#____________________________________
Product_______________________________________
Packaging/Labeling/Inserts
evaluation_____________________________________________
________________________________________________________
__________________________
Remarks_______________________________________________
____________________________________
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Date
inves
tigati
on
ende
d
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RECALL HANDLING
Recall means a firms removal or correction of a
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.
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SOP on recall
RESPONSIBILITY:
General manager / vice president: (QA/QC, Regulatory)
General Manager: manufacturing.
In case of adverse event a committee evaluates the
PROCEDURE:
Any employee becoming aware of such medicine should
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:
__________________________________________________
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TOTAL
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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.
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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.
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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
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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.
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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.
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TERMINATION OF RECALL:
A recall will be terminated when the FDA
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Contd .
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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)
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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
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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.
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