1.0 Purpose
1.1 To establish a standard procedure that deals with the reporting and handing of any product Market complaint.
2.0 Scope
2.1
Applicable for all products manufactured by “NAME”
Pharmaceutical Ltd.
3.0 Responsibility
3.1 The Quality Assurance Department is responsible for maintaining the customer complain Reporting system and also for the timely review and processing of customer complaint.
3.2 Marketing Department is responsible for interfacing with customers and submitting Information to Quality Assurance Department.
3.3 Regulatory
Affairs is responsible for submitting report to Regulatory Authority (if
required)
3.4 It
is the responsibility for all employees to communicate reports of any product
complaint to Quality Assurance through Marketing Department as soon as the
complaint is known.
4.0 Abbreviations and Definitions
4.1 Customer complaint: Any communicate written oral or verbal received directly from any Customer, Retailer, Physician, Field Supervisor (FS), Regional Sales Coordinator (RSC) and Medical Representative (MR) regarding the purity, efficacy, labeling or any quality related complaint, will be considered as “Customer Complaint”.
4.2 PMD: Product Management Department
4.3 MIO: Medical Information
Officer.
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1
None
7.0 Procedure
7.1 PMD shall
train up all MIO and Field Supervisors to inform all customers verbally about
our complaint reporting system.
7.2 Customer shall inform about any complaint to MIO, Field Supervisor who will inform PMD about the
Customer complaint.
7.3 Customer,
Retailer, Physician, Field Supervisor, Regional Sales Coordinator or anyone can
raise customer complaint directly to PMD.
7.4 Contact
customer and collect following information.
7.4.1 Name and
address of the complaint or customer.
7.4.2 Product
description (Name and strength of product)
7.4.3 Product
batch number.
7.4.4 Nature of
the complaint (detailed explanation of the defect and when observed)
7.5 Document
all information about the complaint in the form “Market Complaint Form”
(Annexure-I)
7.6 Send the
report to Quality Assurance for review along with the complaint sample (if
available)
7.7 Assign a
report Number. As for example C´3´2 number ( C/xxx/yy) with ‘C’
for complaint, next three digits being the sequential numbers starting from 001
and last two digits being the year e.g. (C/001/24)
7.8 On receipt of complaint, Quality
Assurance start to process the complaint.
7.8.1 In case of
one or more critical market complaint case, Head of Quality Assurance
consultation with Plant Manager may decide to recall the product as per SOP of
product recall.
7.8.2 Review the
archived complaint reports to determine if any additional reports have been
received for the product. Determine if any adverse trend in product quality is
evident and documented.
7.8.3 Perform an
investigation along with production, Product Development (if applicable),
Quality Control (if Applicable) and report all findings in the complaint
investigation section of the customer complaint record.
7.9
Investigation of the complaint will be as follows:
7.9.1 Review the
batch production Records for the complaint batch for evidence of events or
inspection results that indicate the defect.
7.9.2 Inspect
retention samples of the same batch for reported complaint defect.
7.9.3 Investigate
the complaint sample under simulated use conditions to measure the extent of
the defect and attempt to confirm the complaint
7.9.4 Determine
and authorize additional investigation and further testing, if deemed
necessary.
7.10
Determine if any corrective action can be
taken to prevent any complaint defects on future production batches and
document in the corrective action section of the Customer complaint Report.
7.11 If any
corrective action is proposed, assign the task to an individual or department
and record a target due date.
7.12 Monitor the status of the corrective action. Record on the customer Complaint report when corrective action is
completed.
8.0 Reference Document
8.1 WHO GMP Guideline trs-986, annex-2
8.2 In-house
9.0 Annexure
9.1 Annexure-I : Market Complaint Form
9.2 Annexure-II : Market Complaint Log Book
10.0 Revision History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
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01. |
New |
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02. |
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11.0 Training
11.1 Head of Quality
Assurance or his nominee give the training of all Officer and Manager of all
Department.
Annexure-I : Market Complaint Form
|
Complaint No. |
Date : |
|
Complaint Received by PMD : |
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Complaint Name &
Address: ……………………………………………………………………. ……………………………………………………………………. ……………………………………………………………………. |
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Product
Description |
|||||||||
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Product Name |
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Batch No. |
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Mfg. Date |
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Exp. Date |
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Quantity Received |
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||||
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Complaint Sample Received |
Š
Yes |
Š
No |
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Nature
of Complaint |
|||||||||
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Complaint
Received by QA Sign
and Date |
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Assessment completed by QA |
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Cause: 1. Material
Š 2. Method
Š 3. Document
Š 4.
Operator Š 5. Equipment
Š 6.
Environment Š 7. Vendor
Š 8. Other
Š |
|
|
Assessment
Done By Sign
and Date |
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Complaint Investigation by QA |
||
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Production and
Quality Control document review |
Yes Š |
No Š |
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Retention Sample
Checked |
Yes Š |
No Š |
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Additional
investigation required |
Yes Š |
No Š |
|
Comments
|
||
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Comments of Production: |
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||
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Name
& Designation |
………………………………………………… |
Sign & Date |
…………… |
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Comments of Product Development: |
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||
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Name
& Designation |
………………………………………………….. |
Sign
& Date |
…………… |
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Comments of Quality Control: |
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||
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Name
& Designation |
……………………………………………………. |
Sign
& Date |
…………… |
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Proposed Corrective Action By QA |
||
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Assigned
to: …………………………………………………. |
Sign
& Date : …………… |
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Proposed
due Date ……………………………………….. |
Approved
By ……………………………. |
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Comments of Quality Assurance: |
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||
|
Name
& Designation |
……………………………………………………. |
Sign
& Date |
…………… |
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Approved by Sign & Date |
Head of Quality Assurance |
||
Annexure-II : MARKET COMPLAINT Logbook
|
Sl. No. |
Date |
Market
Complaint No |
Product
Name |
Batch No |
Mfg. Date |
Exp. Date |
Sign & Date (QAD) |
Remarks |
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