1.0
OBJECTIVE:
To lay down the procedure for
handling of market complaints in order to ensure that complaints receipt, investigation
and review promptly with the aim of managing them in a timely manner to satisfy
the complainant and to prevent further occurrences.
2.0
SCOPE:
This SOP is applicable to all the
market complaints received at ----------------------------------
3.0
RESPONSIBILITY:
Head of concerned department i.e.
Quality Control, Manufacturing (Tablets, Capsules, Ointment), Quality Assurance
Head.
4.0
ACCOUNTABILITY:
Head-QA/Plant Head shall accountable
for the compliance of this SOP.
5.0
PROCEDURE:
5.1
Any communication is written, electronic or verbal, received from any
customer, business partners, or regulatory authority, regarding purity,
efficacy, safety, labeling, defective physical appearance, shortage, complaint
related to adverse drug reaction or any other such kind of problems are
considered as Market Complaint and handled as per the procedure mentioned
below.
5.1.1
On receipts of the complaints (either it has received from depot,
Retailor, Customer), the Quality Assurance Head shall depute his officer or
above for classification (Critical/Major/Minor) and investigation. The
Complaint shall be recorded in Market Complaint Log as per Format No.: F/QA-008-01 and a unique number is allotted to the
Complaint. It is allotted as QA/MC/XXYYY
Where
QA-Quality Assurance
MC-Market
Complaint Number
XX-Year
of Complaint like 18 for the year 2018
YYY-Serial
Number of the Market Complaint
Note: After receipt of any complaint information shall be shared
with the party also (Third party/Loan license)
5.1.2
Fill in the other details like Complaint received from, Date, address for
communication, Market Complaint Form as per Format No.: F/QA-008-02.
5.2
Segregate the complaint as per the category mentioned below. Either the
sample or the photographs shall accompany the complaint. Quality Assurance
Manager shall examine the details of Market Complaint and classify the
complaint into one of the following three categories:
5.2.1
Minor: Product Packing or Physical Defects
Related: Such as shortage, broken tablet, packing or sticking of tablets/
improper embossing / and or any other physical defects etc and inform the
complainant and head Quality about this in writing within a time period of not more than 7 days from the date of
complaint has been received.
5.2.2
Major: Wrong labeling or improper batch
details / absence of batch details / wrong embossing / occurrence of particular
matter extraneous matter/ noncompliance of any Pharmacopoeia or In-house
(Patent & Proprietary) test parameters, Product Quality Related, related to
Efficacy / Potency / Safety / Stability Microbiological attributes, counterfeit
product etc.
5.2.3
Critical:
Medical Related: Such as any adverse reaction / allergic reaction / drug interaction /
efficacy.
Market Alert:
When a marketed product poses serious adverse health consequence or death.
5.3
After the complaint entry in the market complaint log and classification
of the complaint, deputed QA designee shall check the genuiness of complaint by
verifying the batch no, coding details, license no, appearance of product of
complaint sample if received with the control sample and batch process record.
After observing the details, ensure that the product is manufactured in our
site or not.
5.4
Minor complaint shall be investigated by the Production Head along with
deputed QA - Officer or above and reported to Head-QA for his evaluation. When
no prime –facie exits as genuine complaint, this must be recorded with reason
and signed by quality assurance head/designee.
5.5
On receipt of quality related complaint (Major), QA – Officer or above
shall examine and give the retention sample of the batch corresponding to the
complaint for analysis in the following cases:
5.5.1
Analytical related matter such as –Drop Assay of active materials, Rinse
in impurities below limits, Dissolution, disintegration, bottle filled weight
variations, Wt. variations in tablet/capsule, lump formation, pH limit, colour
variation, Foul smell, if the complaint sample is received, he shall compare
the retention sample analysis report with that of complaint sample analysis
report and evaluate the differences observed, if any of the data indicates
variance with the initial COA value - (such as, drop in Assay or rise in
Impurities below limits), Head - QA shall proceed for investigation.
5.6
If the results are same as in the COA, the Head QA shall inform the
complainant accordingly.
5.7
If the analysis reveals any stability related problems, deputed QA-Officer
or above may investigate batch history, storage and distribution. Deputed QA-Officer
or above shall share the findings to the Production Head and Head-QA.
5.8
Deputed QA-Officer or above and Production Head shall review various
records/documents during investigation. These may include executed BPCRs
(BMR/BPR), analytical test records, sampling and release records and other
processing records.
5.9 The deputed QA-Officer or above will submit the investigation
report to the Head-QA in Market Complaint form as per Format No.: F/QA-008-02
for review / comments.
5.10 Head QA shall decide the root cause factor for the complaint
on the basis of finding.
5.11 Critical complaint shall be investigated in case of complaint
being product quality related or medical related. Quality Assurance head shall
investigate the complaint along with proposed corrective actions and preventive
actions as per SOP for Corrective Action Preventive Action (SOP-QA-031) to
prevent recurrence.
5.12 The procedure of investigation shall be initiated within 48
hours (for critical complaints: 24 hours) completed with in a period of not
more than 15 days from the date of receipt of the complaint. If the
investigation is not completed within 15 days, then written communication shall
be sent to the complainant immediately and extension of further 7 days is
considered. However the investigation must be completed within 21 days from
date of receipt of complaint. In case if any sample or information is awaited
from the party the complaint remains open after 21 days .If any reply does not
come from the party with in 60 days ,then the complaint is considered as not
genuine and is closed by putting the remark. If party respond after closing of
the market complaint it will be consider as a new market complaint.
Note
- Any complaint
overdue from the required time shall be justified with reason.
5.13 After completing investigation activity,
the Quality Assurance head shall inform President Technical and communicate the
nature of Complaint and action required. If the investigation yields the result
as follows:
5.13.1 Failure of the product
/ batch to meet the regulatory specification.
5.13.2 Physical / visual
deterioration including leakages.
5.13.3 Adverse drug reaction
due to defect in the Product/Batch.
5.13.4 Possibility / evidence of microbiological contamination to an
extent that the product may not be of acceptable quality.
5.13.5 Product / Label mix-up.
5.14 After this, the Quality Assurance Head in consensus with
President Technical takes action to recall of affected / related product
batches as per SOP “Product Recall”.
5.15 After the complaint investigation is completed and based on
the finding of investigation report, action taken regarding the same, the
complaint shall be closed with reply to complaint originator and filled the
remark column.
5.16 The record of complaint, investigation and supporting
documents shall be maintained for a period of at least one year after expiry of
the product batch involved.
5.17 Perform trend analysis of the market complaints annually.
5.18 The effective date for corrective and
preventive action should be specified in the format. The corrective / preventive
action effectiveness and result should be verified by QA Dept then after the
market complaint will be closed out.
6.0
LIST OF ANNEXURE AND FORMATS:
|
Sr. No. |
Title of Format |
Format No. |
|
|
Market Complaint Log |
F/QA-008-01 |
|
|
Market Complaint Form |
F/QA-008-02 |
7.0
REFERENCE:
7.1
SOP-QA-001
7.2
F/QA-001-01
7.3
SOP-QA-031
7.4
SOP-QA-014
8.0
REVISION DETAILS:
|
Sr. No. |
Date |
Reason for Revision |
Revision No |
|
1.
|
31/10/2018 |
New SOP |
R0 |
|
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
|
Sr. No |
Abbreviations |
Details |
|
|
SOP |
Standard operating procedure |
|
|
COA |
Certificate of analysis |
END OF
DOCUMENT
|
Sr. No. |
Date of
Receipt |
Market
Complaint No. |
Complaint
Received from |
Product
Name |
B.No. |
Nature of
Complaint |
Investigation
Carried Out By/On |
Replied To
Complaint Originator By/On |
Final
Close Out Date |
Remarks |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MARKET COMPLAINT INVESTIGATION REPORT
|
1. Market
Complaint No.: |
2. Date: |
|
3. General
Information: Complained received on |
|
|
4. Product
Name: |
5. Batch No.: |
|
6. Mfg Date: |
7. Exp. Date: |
|
8. Pack Size:
|
|
|
9. Complaint
received from:- (Name
& address) |
10. Complaint
sample received ( Put a tick mark)
11. Photograph
sample received ( Put a tick mark)
|
|
12. Description
Of Complaint: |
||||||||||
|
13. Complaint
category (Type of Complaint) ( Put a tick mark)
14. Complaint Sample Observation: |
||||||||||
|
Complaint sample received on |
Received
from |
Observation |
Observed
By/ Date |
Remarks,
if any |
||||||
|
|
|
|
|
|
||||||
15. INVESTIGATION
REPORT
|
15.1 Review
of Respective Nature:- |
|||
|
Is
similar type of complaint received from subjective Batch earlier :- ( Put
a tick mark)
If Yes, specify Year &
complaint number Year:______________ Complaint No.: _____________________ |
|||
|
Is
similar type of complaint received for same product :- ( Put a tick mark)
If Yes, specify Year &
complaint number Year:______________ Complaint No.: _____________________ |
15.2 Observation and analytical
findings (attach analytical records in case of any analysis is carried out)
(Put a tick
mark)
|
Complaint
samples |
Control
samples |
Related
samples (specify) |
|
|
|
|
15.2.1
Analysis details
|
Sample |
Batch No. |
Mfg. date |
Exp. date |
Report No. |
|
|
|
|
|
|
|
Analysis by |
Checked by/on |
Reviewed by/on |
Observation |
Remark if any |
|
|
|
|
|
|
|
15.3 Investigation of finding and comment by Quality Control Head as per SOP-QA-075:- _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ |
||
|
Name:- |
Designation:- |
Sign/Date |
16. FINDINGS
AND COMMENTS
|
16.1 Brief summary of Investigation finding and comments
from QA (Initiator) :- _______________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ _________________________________________________________________________________________ |
|||
|
Name:- |
Designation:- |
Sign/Date |
|
|
16.2 Brief summary of Investigation finding and comments
by Production Head :- ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ _______________________________________________________________________________________________________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ _______________________________________________________________________________________ |
|||
|
Name:- |
Designation:- |
Sign/Date |
|
|
16.3 Review of finding, Root cause /Causative Factor and
comment by Quality Assurance Head:- ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ |
|||
|
Name:- |
Designation:- |
Sign/Date |
|
16.4
Action Required: (put tick mark)
|
Corrective action:- |
|
|
Preventive action:- |
|
|
16.4.1
Evaluation and Conclusion after Implementation
of CAPA : _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ __________________________________________________________________________ |
||
|
Name:- |
Designation:- |
Sign/Date |
|
16.4.2
Closure Remark ( if any) by Quality Assurance Head:- 16.4.3
Close Out Date Of The market complaint After Investigation / Evaluation:____________________ |
||
|
Name:- |
Designation:- |
Sign/Date |
No comments:
Post a Comment
Pharmaceutical guideline only