PPT on Market Complaint Investigation & Recall

1. MARKET
COMPLAINTS
INVESTIGATION AND
RECALL
DHANJAY KUMAR SINGH
(Sr. Executive QA)
SIMPEX PHARMA PVT. LTD., KOTDWAR

2. 2
MARKET COMPLAINTS
INTRODUCTION
A complaint is an objection to something that is unfair,
unacceptable, or otherwise not up to normal standards.
 Complaints may be about Services, Delivery, Quality of
Product, Communication, Response, Time, Documentation,
Billing, Follow up etc.
 Complaint is any communication written or verbal, received
directly from any customer, retailer, distributor, or
representative of contract giver, regarding the quality
attributes, labelling defects or any other matter such
complaints shall be considered as market complaints.

3. 3
Handling of Product Complaints
Section 820.3(b) of the Quality Systems regulation defines
a complaint as "any written, electronic, or oral communication that alleges
deficiencies related to the identity, quality, durability, reliability, safety,
effectiveness, or performance of a device after it is released for distribution”.
We (Simpex) define complaint as –
“any written or verbal communication received from any customer including
qualified personnel, pharmacy, retailer, distributor, or regulatory authorities
regarding the purity, safety, strength, efficacy, labeling, shortage or any
other issue which claim to be related to the quality of the product/packing in
the opinion of the complainer”.

4. 4
Why do customers complain?
Their expectations have not been met…!
When the customer pays for a product or service, it is assumed that the
product will work correctly or that the service received is as promised. Ideally,
the customer will be satisfied, and there will be no complaints.

5. 5
 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.
NEED FOR COMPLAINT HANDLING SYSTEM

6. Classification of complaints
A-Type Complaints
Critical complaints in which product is required to be withdrawn
from the market. (Primary Response shall be given within working hours of same
day of the receipt of market complaint)
Such as
• Adverse Drug Reaction.
• Major health hazard causing permanent deficiency or death.
• Purity & Safety.
• Potency.
• Product Stability

7. Classification of complaints
B-Type Complaints
Major complaints (Primary response to Major defects shall be given within 24
hours of the receipt of the market complaint)
such as
• Problem with primary packaging of the product.
• Chemical / Physical attributes of the product.
• Extraneous contamination, mix-ups, etc.

8. Classification of complaints
C-Type Complaints
Minor complaints (Primary response to Major defects shall be given within 72
hours of the receipt of the market complaint)
such as
• Problem related to labelling / coding of batch details.
• Shortages.
• Secondary packaging material problem, etc.

9. 9
ComplaintsHandling
STEPS INVOLVED IN HANDLING OF COMPLAINTS
Step I: Receiving
Step II: Investigation
Step III: Corrective Actions
Step IV: Feedback to Customers

10. 10
Complaint flow at manufacturing unit …
Reporting
Track action
Acknowledgment Team formation Investigation
Sample check
Record review
Machine review
Expert advice
Action
Investigation
report
Response

11. 11
PRODUCT RECALL
What is
PRODUCT RECALL?

12. 12
PRODUCT RECALL
Recalls are actions taken to remove a product
from the market and restrict further distribution
and sale – Simpex (SQA013)
A recall is when a product is removed from the
market… because it is either defective or
potentially harmful. – US FDA
Permanent removal of therapeutic goods from
supply or use for reasons relating to deficiencies
in the quality, safety or efficacy of goods. –
Therapeutic Goods Administration, Australia

13. 13
PRODUCT RECALL
There should be a system to recall from the
market, promptly and effectively, products known
or suspected to be defective. – WHO
In order to protect public health… necessary to
implement urgent measures such as the recall of
one or more defective batch(es) of a medicinal
product from the market. – European Medicines
Agency (EMA)

14. 14
RECALL CLASSIFICATION
Class 1 Recall
Situation in which there is a reasonable
probability that the use or exposure to the
product will cause serious adverse health
consequences or death.

15. 15
RECALL CLASSIFICATION
Class 2 Recall
Situation in which use or exposure to the
product may cause temporary or medically
reversible adverse health consequences or
where the probability of serious adverse
health consequences
is remote.

16. 16
RECALL CLASSIFICATION
Class 3 Recall
Situation in which use or exposure to the
product is not likely to cause adverse health
consequences.

17. 17
DURATION OF RECALL OPERATION
 Class 1 Recall – Within 24hr to
Maximum 72 hr.
 Class 2 Recall – Within 10 days
 Class 3 Recall – Within 30 days

18. 18
TYPE OF RECALL
 VOLUNTARY RECALL:
This is recall of product from the market or distribution
network of entire available quantity at the time of initiation
of recall, based on decision by Recall Management
Committee. This could be because of:
quality complaint from market, or
discovery of some deficiency, or
stability problem subsequent to dispatch, or
unsold stocks (short expiry)
FORCED RECALL:
This is recall forced by a regulatory agency upon discovery /
reporting of violation or deficiency in the product.

19. 19
PRODUCT RECALL
WHO WILL
INITIATE
THE RECALL?

20. 20
PRODUCT RECALL
 Head QA shall take the decision on recall in consultation with
management of firm including key personnel involved in handling of
recall, based on category of defects identified in product/batch(es).
In Case of filed products, Head – QA shall consult Head-Regulatory
Affairs on the recall strategy, which shall include:
Decision to recall
Need to inform Marketing, Regulatory bodies and Customers,
Extent of effectiveness checks for recall (whether all consignees are to
be notified)
In case of domestic product recall, the local FDA shall be informed
depending on the class of recall.

21. 21
“Drug safety is
everybody’s
concern”

22. Thanks