1.0 Purpose:
To lay down a procedure for handling of market complaints.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.
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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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:
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Training to the concerned person
whenever required.
Implementation of the corrective
action.
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In-charge QC
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:
|
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In-charge QA
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:
|
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 Pharma Research /RA
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:
|
|
Regulatory
Affairs
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:
|
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Plant Head
|
:
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Ensure implementation of the corrective
action.
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Site- Head
Quality
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:
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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
form 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. 01/2005 Where 01 indicates first number of
complaint received and recorded in year 2005 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
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:
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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.
|
Major
|
:
|
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
|
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/ ADL / 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 ± three 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. Feedbacks (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 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
6.0 Abbreviation:
6.1 SOP - Standard Operating Procedure
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 :
Total Quantity of Complaint Sample: Sign: Domestic/ International Marketing/
Originator |
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 )
|
Review & Investigation By Q.C.:
Report of Analysis (if any): Sign / Date: ( QC In-charge )
|
Review & Investigation By Production :
Sign / Date: ( Production In-charge )
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Review & Investigation By Pharma Research / ADL :
Sign / Date :
|
Review & Investigation By Marketing :
Sign / Date :
|
Corrective and preventive action taken :
QA department (Sign / Date)
|
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
Left hand side of register
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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Right hand side of register
Nature of Complaint (Critical /
Major / Minor )
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Corrective action
|
Preventive Action taken
|
Remarks
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Annexure 3
Intimation to Marketing Department
To,
Head – Marketing Department,
C. C.: V. P. (Quality & Regulatory), V. P. (Manufacturing). V. P. (Sale & Distribution), CMD Office
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:
Site Head Quality.
Annexure 4
Investigation of Complaint
Party 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 :
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 :
5.1 Production Dept. :
5.2 In charge - Q. A. :
5.3 QC in-charge :
5.4 Warehouse In-charge :
5.5 Pharma Research / ADL / RA / PD ( 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
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Name
|
Sign
|
Date
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Production In-charge
| |||
QA Incharge
| |||
Plant Manager
| |||
Head Quality
|
Annexure 6
DISTRIBUTION LIST
Sr. No.
|
Name of Department
|
01
|
Quality Assurance
|
02
|
Quality Control
|
03
|
Production
|
04
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Marketing
|
05
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Regulatory Affairs
|
06
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Pharma Research
|
07
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Development Quality Assurance (Formulations)
|
08
|
Corporate Quality Assurance
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Annexure 7
REVISION LOG
Date
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Revision
No.
|
Supersedes
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Reason for Revision
|
Change Control No.
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