Market or Customer complaint is “an expression of dis-satisfaction on a customer’s behalf to a responsible party” when their expectations have not been met! However, Complaint handling is a Good Manufacturing Practice (GMP) requirement, since all complaints concerning potentially defective products must be carefully reviewed according to a written procedure.

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Presented by:
MD. ZAKARIA FARUKI
Manager, Quality Assurance
Silva Pharmaceuticals Limited
Date : June 27, 2022
SPL

2. Who are the customers?
 A customer is the recipient of a goods,
service, product or an idea obtained from a
seller, vendor or supplier via a financial
transaction or exchange for money or some
other valuable consideration.
 In a Pharmaceutical Doctors are the main
customer.
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3.  A Customer complaint is “an expression of
dis-satisfaction on a customer’s behalf to a
responsible party”. It can also be described in a
positive sense as a report from a consumer providing
documentation about a problem with a product or
service. In fact, some modern business consultants
urge businesses to view market complaint s as a gift.
 Generally in the pharmaceutical industry, complaints
are regarding the quality of drug product.
** Complain & Principles as per WHO- TRS 986, annex2 (Attachment)
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What is Customer complaint ?

4. Complaint Rate:
 Complaint Rate: It is the number of
complaint received in a period of time per
10,000 units of all products produced
during this period.
Rate of
Complaint
=
Total number of received complaints x 10,000
Total number of units sold
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5.  Their expectations have not been met!
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6. Basically it is three types:
 Quality complaints: Originate at consumer
level and concern with physical, chemical and
biological properties or condition of labeling
and packaging of the product.
 Adverse reaction complaints: Due to allergic
reactions of any other untoward reaction or
fatal reaction or near fatal reaction.
 Other medically related complaints: Include
complaints such as lack of efficacy or clinical
response.
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7. Source of complaint?
Any persons or place, from which complaint
comes, arises or is obtained. Complaint of a
formulated finished pack may come from the
following sources:
 Marketing, Field Force, Distribution
 Wholesalers/Retailers/Pharmacists/Institutions/
Stockiest/Distributors
 Physicians
 Regulatory Authority
 Users/General Public/Media
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8.  Print: Wrong text, design, or information in any printed
component. Overprinting/embossing wrong, incomplete,
illegible, quality of print poor or unacceptable, poor quality of
material and workmanship for packaging components.
 Damage: Breakage, deformed packs or packages.
 Quantity: Shortages e.g. Volume, quantity or number is less than
declared. Missing tablet/capsule in strips.
 Process: Change in appearance, color, consistency, odor,
microbial growth, and foreign body inside a product, leakage,
broken tablet packed, oozing through capsule, and peeling off of
strips or blister.
 Mix up: Mix up with different products or packaging components
in a pack.
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9.  Minor defects: Basically these are the cosmetics which are visible to
the consumer but no harmful effective to the patient. Example: Color
too pale or strong, rough surface, interior printing.
 Major Defects: These are the defects which result in the product
failing to severe the purpose of its intended use. Fault of this nature
may or may not be readily noticeable. But they may harm the users
either directly or by failure to present an effective dose. e.g. Low
potency, Poor DT or Dissolution, Degradation, Moisture pickup.
 Critical Defects: These are the defects which may be substandard to
the level of hazardous. Faults of the nature can cause serious injury
to health or even endanger in life. e.g Wrong labeling, Wrong
product, Non-sterile parenteral product, Contamination.
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10. Complaint handling is a Good Manufacturing
Practice (GMP) requirement, since all
complaints concerning potentially defective
products must be carefully reviewed
according to a written procedure.
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11. Despite a regulatory obligation in several countries, a
good complaint handling system gives the company
an opportunity
-To improve the quality of their products
-Being a good tool for the maintenance of Good
Manufacturing Practices
-A way to establish a committed relationship with
their customers
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12. Customer Complaint Handling
Receiving complaints
Technical investigation
corrective actions/feedback to
customers
Monthly reports/trend analysis
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15.  Complaint will forwarded by a field
personnel whose Name, Department,
Designation, Territory, Area, Region will
specified in the first page of market
complaint FORM (Attachment)
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16. The person is our customer.
The person will also provide information
about Product Name, Details of Complaints,
Quantity, Batch No., Mfg. Date, Exp. date.
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17. A PMD personnel will receive the complaint
and sample of product under question.
Here, the designated PMD personnel will
give a complaint entry no.
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18.  Complaint entry No. for Duet Tablet (B/N-
040920) was 1550920
 Here, 155 is the complaint serial no.
 09 is the month in which the complaint was
received
 20 is the last two digit of the year
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20.  The PMD personnel will go through the
Complaint and sent it to Head of PMD for his
action.
 Then Head of PMD after reviewing the
situation will forward the complaints along
with the products to Head of Operation.
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21.  Head of Operation will forward
the complaint to the Head of
Plant for appropriate action and
Head of Plant will forward the
complaint Form along with
product to the Head of QA.
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22. Head of QA will assign the job to QA
personnel for investigation through
necessary tests.
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23.  The QA personnel will evaluate the compliant
by analyzing the product against
 "Specifications and Analytical Procedure of
Finished product” for the said Product.
 Compare the product against "Retained
Sample" of the concerned Batch
 Submit his report to the Head of QA.
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24.  After reviewing the report submitted by QA
personnel; QA Manager will give his comments
regarding any actions and forward the same to PD
Dept. PD will investigate the complaint.
 On basis of investigation PD Dept. will give
comments and forwards the complaint to Head of
Production.
 Head of Production will investigate the reason
and give his comments and recommendations,
then send back to QA dept.
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26.  After reviewing all of comments QA Manager will
give his comments regarding any action (including
repacking, reprocessing, recall, or any
preventive/corrective action) if necessary.
 Then send the report to Head of Plant.
 After reviewing Corrective Action Head of Plant will
give his final comments.
 After final evaluation of all comments Head of Plant
will forward the copy to Marketing Department.
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28.  Marketing Department will communicate with
concern MPO’s and provide feedback to Head
of Plant and QA Manager.
 So, Compare to Complaint handling system in
Europe, North & South America we SPL also
has a standard customers complaint handling
procedure.
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29. Finally it can be said that market complaint
handling is not restricted to the Quality
Assurance unit.
It also involves critical staff of the company,
such as-
 Marketing Development
 Sales Development
 Production Development
 Product Development
 Quality Control
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