1.0 Purpose:
2.0 Scope:
This
procedure is applicable to all Market Complaints.
3.0 Responsibility:
Marketing
Department
|
:
|
Forwarding the complaints to QA. (If
any)
Coordination for handling of complaints.
|
Quality Assurance Executive/ Designee
|
:
|
Logging of Complaint received from
marketing department, customer (if any).
Assigning a number to the complaint.
Distribution to concerned departments
Maintaining records. Preparation of
investigation report.
|
In-charge Production
|
:
|
Investigation of complaint /
Preparation of investigation report.
Training to the concerned person
whenever required.
Implementation of the corrective action.
|
In-charge QC
|
:
|
Analysis of the complaint sample
whenever required.
|
In-charge QA
|
:
|
Investigation of complaint
Suggesting corrective actions.
Ensuring implementation of corrective
action.
Training to the concerned person
whenever required.
Reply of the complaint based on the
investigation report.
|
Head Research /RA
|
:
|
Recommendation of any change in
process, if required.
|
Regulatory
Affairs
|
:
|
Forwarding of investigation report to
Regulatory Authorities/Customer (In case of Export only).
|
Plant Head
|
:
|
Suggesting Corrective and
Preventive action.
Ensure implementation of the corrective
action.
|
Site- Head
Quality
|
:
|
Review and approval of investigation
report.
Suggesting Corrective and Preventive
action.
Periodic review of the complaints.
|
4.0 Procedure:
4.1 Product
complaint received serves as an indicator of product quality and potential
source of danger or concern following distribution for sale. Therefore, as GMP
each complaint or inquiry either oral or written is to be evaluated as per this
SOP.
4.2 All the
product complaints are to be promptly forwarded to QA department. If complaints
are forwarded to Site-Head Quality then he has to forward the complaint to QA
department for investigation.
4.3 The
originator has to provide full details of complaint in prescribed format (as
shown in annexure I) and to be send to QA department along with preferably
complaint sample.
4.4 Complaints
received from Drug regulatory authorities are to attend and evaluated as per
the directives received from them.
4.5 Upon
receipt of complaint at Quality Assurance department, QA personnel have to
enter the Complaint in the Market complaint register (as per the Annexure 2). Register consists of
details as mentioned below
4.5.1 Sr. No.
4.5.2 Date of
receipt
4.5.3 Complaint
Reference
4.5.4 Complainant
4.5.5 Details
of complaint (Product Name, Batch No., Quantity of sample & relevant
information)
4.5.6 Nature of
Complaint (To be filled during investigation)
4.5.7 Corrective
Action (To be filled after investigation)
4.5.8 Preventive
Action (To be filled after investigation)
4.5.9 Remarks
:Reply Date (To be filled after investigation)
4.6 Serial No.
in the register is to be entered as Sr. No. / Year. (e.g. 01/2011 Where 01
indicates first number of complaint received and recorded in year 2011 This
complaint log will exist up to 31st December of the same commercial year.
4.7 QA
department has to formalize and investigate any verbal complaint from Drug
Authority / Regulatory Authority /Actual User / Physician / Pharmacist.
4.8 After
logging of complaint, QA department has to start the investigation of
complaint. QA department has to ,Check the nature of the Complaint, verify the
complaint sample if available or control sample & on the basis of initial
investigation categorize the complaints into Critical / Major / Minor.
Critical
|
:
|
Complaints related to defective/ dangerous/ Potentially life-
threatening medicines that predictably or probably could result in to serious
health Risk /adverse events or even death. For Example (But not limited to):
Wrong Product (Label and contents are different),
Correct product but wrong strength, with serious medical
consequences, Wrong active ingredient in a multi-component product, Mix-ups
of some products.
|
Major
|
:
|
Complaints that could cause illness or mistreatment, but are not
critical.
For example (but not limited
to):
Mislabelling (Wrong or missing text or figures)
Missing or incorrect information (leaflets or inserts)
Chemical /Physical contamination
Non-Compliance with specification
|
Minor
|
:
|
Complaint which may not pose a significant hazard to health,
complaints due to secondary packing materials, Shortage complaints, Damage of
containers.
|
4.9 If the initial investigation indicates
that the complaint is of critical, intimate to the Marketing Department (as per
the format shown in Annexure – 3) for the stoppage of further sale and
distribution within 24 hours from the receipt of communication.
4.10 Communicate
to drug liaison, regulatory affairs and client/ customer regarding market
complaint based on nature of market complaint (if required).
4.11 Record the
observations (i.e. Critical/Major/Minor) in the Record for Market Complaint and
start the complete investigation.
4.12 In case of
quality related complaint, send the complaint sample if available (or sample
from control sample) to Quality Control for analysis. Depending on the nature
of complaint the control sample and complaint sample (if any) is to be analyzed
for the relevant test parameters. Analysis of the sample is to be carried out
as per the specification by which the product was initially released.
4.13 Test
parameters to be performed for the complaint sample are to be specified by
Site-Head Quality or his authorized nominee. After completion of
analysis, QC has to send the report of Analysis to QA for further
investigation.
4.14 QA
department has to consult (as per requirement) with Pharma Research/Marketing/ Production for necessary investigation at their end. Appropriate
action is to be chosen from the following, depending on the nature of the
complaint:
4.14.1 Observation
and analysis of complaint sample and packing slip (if any)
4.14.2 Observation
and analysis of retained sample of the same batch or other batches of same
product.
4.14.3 Comparison
of results of above.
4.14.4 Review
of Product specification, Batch manufacturing record, batch analytical records.
4.14.5 Facility
or equipment problem.
4.14.6 Training
records of concerned operators staff and identify the training needs if any
4.14.7 Trend
analysis, Stability data, process validation report, product development
report. Based on the observations, identify the root cause of the incidence.
4.14.8 Review
of Control sample of ±3 Batch Nos. from market complaint batch.
4.15 Take
Medical opinion (if any) from medical experts with concern patient (if any) as
a part of investigation.
4.16 Prepare an
investigation report as per the Annexure
4 (if require additional sheets are to be enclosed.)
4.17 Mention
all the corrective and preventive actions in detail & target date for the
completion of the corrective action in the investigation report. Forward it to
the Plant Head & Site-Head Quality for review.
4.18 Prepare a
reply based on the complete investigation.
4.19 Forward
the duly filled complete investigation details to Marketing department
along with the reply letter mentioning the corrective and preventive actions
taken to avoid future recurrence of the incidence (In case of Domestic
complaint) and forward the same to RA (In case of export
complaint).
4.20 As a part
of investigation, the need for recalling the batch is to be decided by
Site-Head Quality depending on the nature of the complaint. In such cases the
SOP for Product Recall is to be followed.
4.21 Initial
response shall be sent to Marketing department within 7 days for domestic
complaints and 10 days in case of Export complaints.
4.22 Marketing
Department /RA department has to forward the Reply to the customer with a copy
of same to QA department.
4.23 Feedback
from the customer/complainant on the reply is to be taken. Feedback (if any)
received from the customers/complainant are to be forwarded to QA department
for records.
4.24 The
complaint shall be treated as “Closed” after receiving feedback from the
customer. The time period for receiving feedback from the customer is:
4.24.1 Customer
feedback from Domestic Market within 3 weeks.
4.24.2 Customer
feedback from International Market within 4 weeks.
If feedback is not received within the stipulated
time, the complaint shall be treated as closed.
4.25 Review the
customer complaint status and customer complaints every quarter to evaluate
specific or recurring problems which require further attention.
4.25 Maintain
all the records involving market complaints handling till one year after the
Date of expiry of
the product or one year after the date of complaint received whichever is longer.
5.0 Revision Log:
Refer Annexure 76.0 Annexures:
Annexure
1
: Record for market
complaint
Annexure
2
: Market complaint
register
Annexure
3
: Intimation to Marketing Department
Annexure
4
: Investigation of
complaint
Annexure
5
: Flow for handling
of market complaints
Annexure
6
: Distribution list
Annexure
7
: Revision log
Annexure
1
Record
for Market Complaint
To be filled by Domestic/International
Marketing/Originator :
|
Date:
Date
of Receipt of Complaint
Complaint Details :
Letter Reference(if any):
Name and Address of complainant:
Complaint From :
Complaint Received Through :
Name of Product
:
Batch
No :
Mfg.
Date
: Exp.
Date :
Nature of Complaint
:
|
Investigation Details :
To be Filled by QA :
Complaint No:
Name of Product
:
Batch No :
Mfg. Date
:
Exp. Date :
Dosage form:
Marketing Authorisation Number/ Mfg. Lic. Number:
Nature of Complaint : Critical / Major / Minor
Physical description of the Complaint Sample :
|
Review & Investigation by Q.A.
Sign
/ Date: ( QA In-charge )
|
Review & Investigation By Q.C.:
Report of Analysis (if
any): Sign / Date: ( QC In-charge )
|
Review & Investigation By Production :
Sign
/ Date: ( Production In-charge )
|
Review
& Investigation By Research :
Sign / Date :
|
Review & Investigation By Marketing :
Sign / Date :
|
Corrective and preventive action taken :
QA department ( Sign / Date )
|
Reviewed By :
Site-Head Quality (Sign / Date)
|
Forward to RA/Marketing in case of Export/Domestic
complaint respectively :
Reply Ref:
Head
- RA ( Sign / Date )
|
Annexure
2
Market
Complaint Register
Sr.No.
|
Complaint Reference & Date
|
Product Details
|
Complainant
|
Details of Complaint
|
Nature of Complaint (Critical / Major / Minor )
|
Corrective action
|
Preventive Action taken
|
Remarks
|
Annexure
3
Intimation
to Marketing Department
To,
Head Marketing,
Subject: Immediate stoppage of sale and further
distribution of the product.
With respect to market complaint received by us, you
are requested to stop the further distribution and sale of the following
product.
Product Name:
Batch No.
Mfg. Date:
Exp. Date:
Quality Head
Annexure
4
Investigation
of Complaint
Ref. No :
|
||||
Complaint From :
|
Date of Receipt :
|
|||
ID No :
|
||||
Product's Name :
|
Batch No :
|
|||
MFD :
|
EXP :
|
|||
Initiated on :
|
Completed on :
|
Sign QA :
|
||
1. Incidence :
1.1 Interpretation
:
2. Scientific
or Practical Reason :
3. Identification
of Real Problem / Area :
4. Responsible
for Activity :
5. Reviewed By
:
5.1 Production
Dept. :
5.2 In charge
- Q. A. :
5.3 QC
in-charge
:
5.4 Warehouse
In-charge :
5.5 Research (
If required )
Corrective Action
Preventive Action:
_______________________
Plant Head (Sign. & Date)
Conclusion:
_______________________
Head Quality (Sign. & Date)
___________________________________________________________________________
Attach Extra Sheet for the Action Plan & Target
dates, if Necessary
APPROVAL
Department
|
Name
|
Sign
|
Date
|
Production Manager
|
|||
QA Manager
|
|||
Plant Head
|
|||
Head Quality
|
Annexure 6
DISTRIBUTION LIST
Sr. No.
|
Name
of Department
|
01
|
Quality
Assurance
|
02
|
Quality
Control
|
03
|
Production
|
04
|
Marketing
|
05
|
Regulatory
Affairs
|
06
|
Pharma
Research
|
07
|
Development
Quality Assurance (Formulations)
|
08
|
Corporate
Quality Assurance
|
Annexure 7
REVISION LOG
Date
|
Revision
No.
|
Supersedes
|
Reason for Revision
|
Change Control No.
|
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