Complaints evaluation and handling, Investigation and Determination, CAPA and Return and Recall of products in Quality Management system in pharmaceutical or any industry.

1. COMPLAINTS
Presented by - Mayuri M. More
Department - QAT(F.Y.M.Pharm.)
Subject - QMS
Modern College of Pharmacy (For ladies) Moshi,pune.

2. CONTENTS -
 Complaints
 Evaluation and handling
 Investigation and Determination
 Corrective And Preventive Action
 Returns And Recall

3.  Complaints -
A statement that is something wrong or not g
ood enough,which show customer dissatisfa
ction about the company and the product.
 Reason -
 It gives the company an opportunity to impr
ove the quality of products.
 It is helpful to maintain CGMP.
 Improve safety and performance of device.

4. Fig: Complaints

5.  Types Of Complaints -
1. Quality Complaints - Originate at customer
level and concerned with physical,chemical
and biological properties of products.
2. Adverse Reaction Complaints - Due to all
ergic reaction or fatal reaction.
3. Other Medically Related Complaints - Inc
lude Complaints such as lack of efficacy or
clinical response.

6.  Steps Involved In Handling Of Complaints -
 Step1: Receiving Complaints - It is important t
o have a open channel with customer in order t
o receive their suggestions, doubts and complai
nts.Generally these channels are toll-free numb
er,e-mails ,chat rooms and P.O. box.
 Step2: Technical Investigation -Upon receipt
of the investigation form the QA unit is able to st
art the investigation,which can be devided in tw
o phases.

7. 1. Documentation Based - Checking if this com
plaint occurred previously in the same lot.
2. Laboratory Analysis Phase - Requesting Q
C laboratory to analyze both (Complaints and
retained). If the customer did not send the co
mplaint sample for analysis the lab.Investigati
on will be carried out only with the retained.
Cont...

8. Step3: Corrective And Preventive Action
-
 Corrective Action - Action taken to prevent rec
urrence of a non-conformance. Action taken after
the task.
 Preventive Action - Action taken to prevent oc
curence of a non-confermance.Action taken befor
e the task.

9. The criteria for choosing appropriate action
depends on the nature of the complaint,and
the complaint insidence.
 Step4: Monthaly Report And Trend Analy
sis -
Monthly Report should be elaborated in order t
o evaluate the amount and nature of Complaint
s.
Cont...

10.  Monthaly Report must answers the f
ollowing questions -
 How many Complaints did the company r
ecieved in period?
 How many were confirmed?
 How many were not confirmed?
Cont...

11.  RETURNED -
Distributed finished products can be returned
for various reasons. These can be for substan
dard quality, damage of packaging, stability re
lated issues; or any other such reasons.
 Regulatory Guidelines are available to h
andle such issues -
 Product returned from market shall be iden
tified, and stored securely.
 A finished Pharmaceutical

12. Cont...
meets appropriate standards, specifications,
and characteristics.
 Record of returned drug product shall be
maintained and shall include the following:
 The name and label potency of the drug pr
oduct dosage form.
 Lot/control/batch number of the drug prod
uct.
 Reason for return.
 Quantity returned.

13. Cont...
 Date of disposition.
 Ultimate disposition of returned drug pro
ducts.
 Documents Required -
1. SOP on handling returned drug products.
2. Records of returned drug products includi
ng action taken on it and associated batch
es if any.

14.  Recall -
Recall is an Action to withdraw /remove the dr
ug from distribution or use by manufacturer for
various reasons.
Ex: substandard quality detected after the pro
duct was distributed.
Damage of product during transit.
 Recall applies a;
1. Total ban or permanent removal.
2. Temporary ban or temporary removal.

15.  Reason -
 FDA authorities may order a Recall
for substandard quality of the finish
ed product.
 Accidental damage occurs during tr
ansportation.
 Problems related stability.
 Types of Recalls -
1. Compulsory Product Recall - In
dustry do not take responsibility.

16. Cont...
2.Voluntarily Product Recall - Industry v
oluntarily recall products.
 Time Line for Recall -
I. For class1: within 24 hours upto a maxi
mum 72 hours.
II. For class2: Recall upto a maximum of 1
0 days.
III. For class3: Recall upto a maximum of 3
0 days is allowed.

17. Fig: Level of Recall

18.  Reference -
1. Monohar A. Potdar Pharmaceutical Quality
Assurance Nirali prakashan,page no.10.2-1
0.4.
2. Krishna Majik Department Of Quality Assur
ance KLEU's College of pharmacy.

19. THANKS