SOP For Handling of Market Complaint
SOP For Handling of Market Complaint
SOP For Handling of Market Complaint
pharmabeginers.com/sop-for-handling-of-market-complaint
Standard Operating Procedure (SOP) for Handling of Market Complaint of Finished Pharmaceutical Drug
Product. A market/consumer complaint is a notification that the product in commercial distribution-
1.0 Purpose:
To provide a guideline for handling market complaints of Drug Products.
2.0 Scope:
This guideline is applicable to the handling of complaints of drug products at the formulation
manufacturing locations of Pharmaceutical Industries.
3.0 Reference:
References :
4.0 Responsibility :
Corporate Quality shall be responsible for –
Receive and log in to the market complaint in the market complaint register.
Collect the adequate information required and the Complaint sample, if available, for
complaint investigation.
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Review, if required, Investigation Report or Preliminary Investigation Report received from the
location.
Prepare PIR in case of quality-related market complaints where the investigation may take
time.
Prepare an action plan for investigation of the quality-related complaint and to get it approved.
Monitor the analysis of complaint sample and/or control sample as per the approved action
plan.
Production Head (Manufacturing Head and Packing Head) shall be responsible for-
Receive complaint from CQ or any other source and to handover to QA for investigation
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Review and approve the Investigation Report.
Review and approve the Investigation Report with special reference to CAPA. .
Distributing location (for Loan License / Third Party Products) shall be responsible for-
To file complaints, received for the products distributed by the distributing location and send it
to the parent manufacturing company for investigation.
To receive the Investigation Report from the parent manufacturing company and take further
action as per it’s location SOP.
Arrange for replacement sample in case of the genuine market complaint as and when
required with a copy to CQ.
Prepare and send a reply to the customer/doctor as and when required with a copy to CQ.
Any adverse experience associated with the use of a drug in humans, whether or not
considered drug-related, includes the following :
Adverse experience occurring from the use of a drug product in professional practice;
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An adverse experience occurring from drug withdrawal and
Any adverse drug experience that places the patient, in the view of the initial reporter, at
immediate risk of death from the adverse drug experience as it occurred, i.e. it does not
include an adverse drug experience that, had it occurred in a more severe form, might have
caused death.
Any adverse drug experience occurring at any dose that results in any of the following
outcomes :
OR
Any adverse drug experience that is not listed in the current labeling for the drug product.
This includes experiences that may be symptomatically and path physiologically related to an
event listed in the labeling but differs from the event because of greater severity or specificity.
“Unexpected”: As used in this definition, refers to an adverse drug experience that has not
been observed previously (i.e. not included in the labeling) rather than from the perspective of
such experience not being anticipated from the pharmacological properties of the
pharmaceutical product.
Factory Management: Plant Head and Quality Head together are termed as Factory
Management.
Subject Matter Experts: Individual or a group of individuals who has a better understanding
of the matter either through qualification or training or experience or combination of above.
Abbreviations :
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CRA: Corporate Regulatory Affairs Department
All complaints, for the products manufactured in India, received at the location, by any other
employee of the company or any other office, shall be forwarded to CQ for registration.
However, the location can assign location complaint numbers and start an investigation
without waiting for the CQ registration number.
On receipt of the CQ registration number, the same shall be updated in the register.
Market Complaints about other (overseas) locations shall be received and registered by
respective manufacturing locations. Only critical complaints shall be informed to CQ.
On receipt of the market complaint, CQ shall classify these complaints into Quality complaints
(Quality of product or complaint related to primary packing of product) and shortage
complaints (Complaints of shortages or excess related secondary packing or tertiary packing)
and register them in register as per attachment – 1 and attachment – 2 This register shall be
maintained in soft file.
For complaints from Indian Market, in order to understand the nature of the complaint, efforts
shall be made by CQ to discuss and understand the nature of complaints by contacting
Doctors or Nursing Staff directly or through field staff in the marketing department.
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For complaints from other locations, similar efforts shall be made through appropriate
channels.
This can be by QA in the US, Canada, Mexico, etc. or by QP in EU or through other personnel
as appropriate in other countries.
For the complaints from the US market, related to products manufactured at the Indian
Manufacturing location, CQ in consultation with Corporate Regulatory Affairs shall decide on
the need to file a field Alert Report.
For products manufactured at other (overseas) locations such decision locations shall be
taken by location QA in consultation with location RA.
Where,
YY stands for the last two digit of the year. 20 for 2020 and 21 for 2021 and so on
ZZZ stands for Serial number starting from 001 for each calendar year.
First complaint for the year 2011 shall be numbered as MC-20-001 and for the year 2021
shall be numbered as MC-21-001, and so on.
Where,
YY stands for last two digit of the year. 20 for 2020 and 21 for 2021 and so on
ZZZ stands for Serial number starting from 001 for each calendar year.
Count related complaints for tablets / capsules packed in bottles, Missing tablet/capsule in
blister/strip, missing vial or ampoule in a combi pack, empty show box, shall be treated as
packing related complaints and not as a shortage or excess complaints.
If complaints are already classified as ADE or non-ADE, all ADE complaints shall be
forwarded to Drug Safety Department for records and PSUR purpose as applicable.
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If at the time of receipt complaints are not classified as ADE or non-ADE complaints then all
quality-related complaints shall be evaluated for ADE or non-ADE complaints. Drug Safety
Department shall be consulted if required.
If any complaint is classified as ADE complaint, it shall be forwarded to the Drug Safety
Department also.
All quality complaints shall be further sub-classified into different categories as per
Attachment – 3 and Attachment – 10.
Location QA shall log these complaints into location complaint register (Attachment – 4)
within 1 working day and shall allot a unique location complaint number.
Preliminary investigation :
In the case of Quality Complaint where there is a serious risk to the patient’s health PIR shall
be prepared within 2 working days.
Quality Head shall decide on this. If required opinion from Medical Expert / Department can be
obtained.
Preliminary investigation for complaints classified as ADE complaint (other than those covered
under above), shall be done within five working days from the date of receipt of the complaint.
A preliminary investigation shall evaluate any abnormality during batch manufacturing which
might be prima fascia responsible for such complaints.
The information regarding the use of suspected drug products in combination with other
drug products.
Based on the batch record and product literature evaluation a Preliminary Investigation Report
(PIR) shall be prepared as per attachment – 6.
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The location shall forward the PIR to Corporate Quality Department for forwarding to the
complainant, if found satisfactory, if CQ has any queries or suggestions for improvement, PIR
shall be returned back to the location for updation.
Location QA shall file the PIR. On completion of the investigation, the PIR shall be attached
with the market complaint Investigation Report.
SME shall Investigate the complaint in detail to identify the root cause of the complaint.
QA shall co-ordinate with CQ and try to get as much information as possible from the
complainant and / or Healthcare professional.
Such efforts should be documented and enclosed with the Final Investigation Report.
All efforts shall be made to secure the complaint sample for effective investigation.
Batch manufacturing and packing records and all other related records shall be reviewed to
evaluate the possible root cause of the complaint.
If the batch number is unknown, Batches manufactured within the last 6 months shall be
evaluated with special reference to events / OOS or OOT that could be attributed to the root
cause of the complaint.
Depending on the nature of the market complaint, QC analytical data shall also be reviewed. If
required stability data and trend data shall also be reviewed.
Control samples and complaint samples (if available) shall be analyzed for relevant
parameters to establish the acceptability of the product.
However, if the complaint samples are received in suspicious conditions, justification for not
analyzing the complaint samples shall be documented.
Based on the root cause identified during the investigation, impact assessment on the
complaint batch and other batches of same product or different product manufactured on the
same line shall be evaluated.
If the market complaint is confirmed, the risk-based decision on the marketed batches shall be
evaluated and if required further actions such as FAR (for US marketed products only), or
similar reporting as applicable, Recall, etc. shall be taken.
Market complaint investigation shall be completed in 30 days from the receipt of the
complaint.
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If in these 30 days complaint samples are not received or complaint samples are received but
not analyzed, complaint investigation except for analysis of complaint samples shall be
concluded within 30 days.
Addendum report, including analytical results and additional investigation if carried out based
on the analytical results of complaint/control samples, shall be prepared within 15 days from
receipt of complaint samples except for tests where test period is more than 3 days, such as
sterility test, antimicrobial efficacy test, Microbial Limit test or Biological Assays, shall be
completed within 7 days after receipt of analysis results.
Extension to all these timelines can be given by the Quality head or his designee subjected to
appropriate justification for extension (Refer attachment – 7).
The market complaint report shall be compiled as per the format (Refer Attachment – 8).
Based on the root cause identified during the investigation, impact assessment shall be done
on the batch(es) of the same product or different products handled on the same manufacturing
line.
Market Complaint samples received without a specific batch number shall be retained
for 1 year from the date of receipt of the complaint sample.
If the complaint sample cannot be retained because of the nature of the product or any other
reason, the justification for not retaining complaint samples shall be documented in the
investigation report and a photograph of complaint samples shall be kept in record.
QA shall send a copy of the Investigation Report to CQ along with necessary attachments.
CQ may review the Investigation Report and ask for further investigation details if required.
After completion of the investigation, if required, location QA shall initiate CAPA as per SOP
for Corrective and Preventive Action.
The risk-based decisions shall be taken for the batch(es), which are impacted.
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Handling of Repetitive ADE complaints :
If ADE market complaint of similar nature is reported by more than one complainant at a time,
CQ shall instruct location to prioritize the investigation and based on investigation outcome
further decision on batch shall be taken.
The location shall investigate the complaint as per the investigation procedure explained
onwards and sent Investigation Report to CQ.
If the ADE is not listed in Product literature then-current Product Literature of Reference
(Innovator) drug shall be reviewed to ensure that there are no updates in the innovator’s
literature.
The matter shall be discussed with the Medical department and CRA department to evaluate
any need for revision in product literature.
If required, the Distribution Department shall send the initial response with/without
replacement sample to the complainer and send a copy to CQ.
Subsequently, CQ shall send a copy of the initial response to the concern location for record
purposes.
After receipt of the Investigation Report, CQ shall send either investigation details or reply for
the complaint to the complainant or concern department with a copy to the concerned location
for record purpose.
The location shall file this response along with the investigation report.
Such reports shall be closed in 2 stages. Level – I closure shall be after approval of the
investigation report by Factory Management. Level – II closure of such a report shall be
done after the implementation of CAPA.
Market Complaint shall be closed for both level – I and Level – II simultaneously (i.e.
with approval of Investigation report by the factory Management).
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NOTE: If the market complaint is closed and on a later date any communication is
received from the complainant giving additional information or providing clarity about
information provided earlier and that new information/clarification may have an impact
on investigation then the complaint file shall be re-opened and an addendum
Investigation Report shall be prepared.
NOTE: Complaints related to primary packing (such as Count variation in the bottle, empty
pocket, missing component, missing label or batch details on the unit pack, missing applicator,
empty vial/ampoule, leakage in vial/ampoule/bottle, Damaged primary packings such as
bottle, ampoule or vial, etc.) shall be classified as Quality complaints. Refer attachment – 3.
These are the complaints related to shortages or excess quantities of product in secondary
packing (Less or excess vials/bottles/strips/blisters etc. in show box or Shipper boxes, Less or
the excess number of show boxes in a shipper box, Damaged Outer or Inner Shippers,
Missing labels on outer or inner shipper but proper labeling on the unit pack, missing
leaflet/product literature (where applicable), the difference in weight mentioned on shipper and
actual weight of the shipper on receipt, etc.).
SME shall investigate the complaint to identify the root cause of the complaint.
Based on the root cause identified during the investigation, impact assessment on the
complaint batch and other batches of the same product or different product manufactured on
the same line shall be evaluated.
If the market complaint investigation indicates any CAPA then the risk-based decisions on the
marketed batches shall be evaluated and if required further actions such as FAR (for the US
marketed products only), or similar reporting to the regulatory agency as applicable, Recall,
etc. shall be evaluated.
Complete the Market complaint investigation in 30 days from the receipt of the market
complaint.
Compile the market complaint report as per the format. (refer Attachment – 8).
QA shall send a copy of the Investigation Report to CQ along with necessary attachments.
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CQ may review the Investigation Report and ask for further investigation detail if required
All shortage / Excess related complaints where no CAPA has been defined shall be treated as
closed once Investigation Report is signed by the factory Management.
Complaint Investigation Reports in which CAPA has been defined shall be treated as closed
for level – I after the signature of Factory Management. Level – II closure of such complaints
shall be done after the implementation of CAPA.
Complaints related to Contract Manufacturing / Third Party Products shall be received and
registered as per procedure defined in point no. 6.2.1 to 6.2.6
The third-Party coordinator shall forward the market complaint to the respective manufacturing
location for investigation.
Market complaint investigation shall be completed as per the timelines defined in the technical
agreement.
The third-Party coordinator shall coordinate with the third party for the Investigation Report
and shall forward the report to CQ.
CQ may review the Investigation Report and ask for further investigation details if required
Trends for Quality and packing related market complaints with reference to the product, nature
of complaints, open and closed complaint, the time required for closure of complaint, CAPA
Status, and its effectiveness shall be prepared on Half-yearly basis by location QA.
Trends for shortages related market complaints with reference to the product, nature of
complaints, Zone, CNF agent, open and closed complaint, time required for closure of
complaint, CAPA Status, and its effectiveness shall be prepared on Half-yearly basis by
location QA.
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The decision for Umbrella investigation shall be taken by QA Head in consultation with Quality
Head.
Complaint No.
Reference No.
Product
Batch No.
Location
Complaint details
Nature of complaint
Market
Level – I closing
Level – II closing
Remarks
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Complaint No.
Product
Batch No.
Location
Complaint details
Market
Level – I closing
Level – II closing
Remarks
A Quality
Q2 Change in Color / Physical form (caking or lump formation) / odor/ Turbidity / precipitation.
B Packing
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P1 Improper/ Missing overprinting on the primary pack.
P5 Empty bottle / vial / ampoules / Leakage / Volume variation / less volume / missing component in
combipack.
P6 Improper sealing.
Complaint No
CQ Complaint No.
Product
Batch No
Dosage form
Complaint details
Nature of complaint
Market
Zone
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Date on which Investigation Report sent to CQ
Recommended CAPA
Remarks.
Note: This attachment shows only a few examples of market complaint with the suggested investigation.
This attachment shall be edited based on the type of formulation (sterile/non-sterile) manufactured at the
location and also based on the type and trend of the complaint received at the location.
Active RM calculation.
added of active and inactive RM (MRO and Coupons) against bill of material.
Source of material.
Dispensing precautions: e.g. API dispensing and storage in the black/ light resistant bag or
container.
Processing precautions: e.g. dissolved oxygen, low light, nitrogen flushing or any other.
Processing parameters.
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Complaint and control sample analysis for,
Volume variation,
Content uniformity.
Moisture content.
Storage condition.
Improper sealing.
Condition of container label and/or show box to eliminate the possibility of leakage.
Active RM calculation
added of active and inactive RM (MRO and Coupons) against bill of material.
Trend of yield.
Sequential log of filling or compression or capsule filling machine for the breakdown.
Content uniformity.
Volume variation.
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Physical inspection of control and complaint sample.
Minor crack
Improper sealing.
Quality/compatibility of closure.
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5 Adverse reactions
Assay / Dissolution
Related Substances.
Minor crack.
Improper sealing.
Special precautions required during processing e.g. dissolved oxygen, low light, nitrogen
flushing or any other.
Recovery procedure.
Stability data.
Storage condition.
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Physical inspection of complaint and control sample.
8 Broken Tablet.
Training record of the visual checkers and strip packing machine operators.
Analysis of control and/or market complaint sample for monitoring of de-foiling and repacking
activity.
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Lyophilization menu.
Moisture content
Degradation
Physical inspection of control and complaint sample for physical appearance of primary pkg.
the material of two products under question.
Sequential log of machine at every stage to know the previous or next product taken on the
same machine and to ensure absence of same /similar product in the surrounding area.
Other products packed on the same day on the nearby labeling machine or packing line of the
product under question.
Wrong labeling/packing.
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Training record of packers.
Compatibility study.
12 Fake product.
Comparison of complaint sample with control sample for the appearance of strip/ label (font
size of letters, printed text matter, size of the pocket, the gap between the two pockets,
knurling pattern, the logo of the company, movement of tab or cap in the pocket, etc).
Market complaint sample with control sample for appearance of tablet or capsule (size or
dimensions, color, imprint, embossing, edge type, etc).
Comparison of primary packaging material (Vial / ampoule) for shape and size, amp. sealing
height, type of seal, logo on the seal, color of the seal, type of rubber stopper, etc.
In-process checks by production and QA during packing (e.g. on line compressed air flow or
any other system followed to remove empty plastic container or empty pocket in strip or
blister).
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Balance performance and calibration check record.
Vendor of the primary container (as the cause of empty container may be hairline cracks due
to weak MOC of the container).
Procedure to be followed for the leftover pkg. The material after completion of packing.
PM vendor audit.
Training of packers.
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Physical Inspection of control and complaint sample (if available).
Startup clearance.
In-process checks by production and QA during packing (e.g. on line compressed airflow or
any other system followed to remove such container).
Yield and reconciliation of the batch and comparison with the trend.
16. Non-working Devices (Auto-injector pens, Prefilled syringes or devices for inhalation)
Startup clearance.
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Performance check record during assembling / filling.
Procedure to be followed for the leftover pkg. The material after completion of packing.
PM vendor audit.
Training of packers.
Nitrogen flushing.
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Mesh size of the sifter, direction of knife.
Lyophilization cycle.
To :______________________________________________
From :____________________________________________
Date :________________
Subject : (Mention Reference location, CQ and third party if available, complaint numbers).
Product :___________________________________________
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Manufacturing Date :_____________
Expiry Date___________________
Complaint Details:______________________________
Regards,
(Quality Head)
Product _________________________________
Batch No._________________________________
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Mfg. date _________________________________
Exp. Date_________________________________
Complainant_________________________________
History _________________________________
Review of other related documents (like a sequential log of m/c etc) _____________________
Attachments _________________________________
Impact on current batch / Other batches of the same product / Other products__________
Corrective action is taken / to be taken with the target completion date ________________
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Preventive action is taken / to be taken with the target completion date ______________________
Conclusion _________________________________
Prepared by _________
Approved by QA Head____________
Sr. Date Reference The initial Proposed Extension Approved Sign Remarks
No. complaint Target date for Date for Note on /
number. completion completion Number Date
Attachment – 10: Flow chart showing types & definitions of the market complaint.
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Attachment – 11: Flow chart for the handling of the market complaint.
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Annexure
Annexure – 1: Flow chart for the handling of complaints received at the Distribution location.
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November 21, 2019
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