SOP for
Handling of Market Complaints in Pharmaceuticals
1.0 Purpose:
To lay down the
procedure for handling of market complaints.
2.0 Scope:
This procedure is applicable to
all Market Complaints.
3.0 Responsibility:
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Marketing Department
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Forwarding the complaints to QA. (If any)
Coordination for handling of complaints.
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Quality Assurance Executive/ Designee
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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.
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In-charge Production
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Investigation of complaint / Preparation of investigation
report.
Training to the concerned person whenever required.
Implementation of the corrective action.
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In-charge QC
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Analysis of the complaint sample whenever required.
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In-charge QA
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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.
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Head Research /RA
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Recommendation of any change in process, if required.
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Regulatory
Affairs
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Forwarding of investigation report to Regulatory Authorities/Customer
(In case of Export only).
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Plant Head
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Suggesting Corrective and Preventive action.
Ensure implementation of the corrective action.
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Site- Head
Quality
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Review and approval of investigation report.
Suggesting Corrective and Preventive action.
Periodic review of the complaints.
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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.
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Critical
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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.
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Major
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:
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Complaints that could cause illness or mistreatment, but
are not critical.
For example (but not limited
to):
Mislabeling (Wrong or missing text or figures)
Missing or incorrect information (leaflets or inserts)
Chemical /Physical contamination
Non-Compliance with specification
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Minor
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Complaint which may not pose a significant hazard to
health, complaints due to secondary packing materials, Shortage complaints,
Damage of containers.
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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 7
6.0 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
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To be filled by Domestic/International
Marketing/Originator :
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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
:
Total Quantity of Complaint
Sample:
Sign:
Domestic/ International Marketing/
Originator
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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 :
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Review & Investigation by Q.A.
Sign / Date: ( QA In-charge )
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Review & Investigation By Q.C.:
Report of Analysis (if
any):
Sign / Date: ( QC In-charge )
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Review & Investigation By Production :
Sign /
Date: ( Production In-charge )
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Review & Investigation By Research :
Sign / Date :
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Review & Investigation By Marketing :
Sign / Date :
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Corrective and preventive action taken :
QA department ( Sign / Date )
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Reviewed By :
Site-Head Quality (Sign / Date)
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Forward to RA/Marketing in case of Export/Domestic
complaint respectively :
Reply Ref:
Head - RA ( Sign / Date )
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Annexure 2
Market Complaint Register
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Sr.No.
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Complaint Reference & Date
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Product Details
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Complainant
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Details of Complaint
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Nature of Complaint (Critical / Major / Minor )
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Corrective action
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Preventive Action taken
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Remarks
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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
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Ref. No :
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Complaint From :
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Date of Receipt :
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ID No :
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Product's Name :
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Batch No :
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MFD :
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EXP :
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Initiated on :
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Completed on :
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Sign QA :
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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
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Department
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Name
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Sign
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Date
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Production Manager
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QA Manager
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Plant Head
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Head Quality
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Annexure 6
DISTRIBUTION LIST
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Sr. No.
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Name of Department
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01
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Quality Assurance
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02
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Quality Control
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03
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Production
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04
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Marketing
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05
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Regulatory Affairs
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06
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Pharma Research
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07
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Development Quality Assurance (Formulations)
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08
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Corporate Quality Assurance
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Annexure 7
REVISION LOG
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Date
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Revision No.
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Supersedes
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Reason for Revision
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Change Control No.
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