(https://pharmablog.

in/handling-of-market-complaints-sop/)

SOP for Handling of Market Complaints in Pharmaceuticals |

Handling of market complaints in pharmaceuticals |

Handling of Market Complaints SOP covers the following points:

 How to handle market complaint in pharma industry
 Handling of Market Complaints procedure
 Complaint capture and processing
 Complaint management
 Corrective Action Plan
 Complaint resolution and closure
 Retention of Complaint Test Samples
 Complaint Report format
 Complaint Register format
 Product Complaint Form format

1.0 OBJECTIVE
To establish a procedure to investigate, document, respond and review of all product
related complaints.

2.0 SCOPE
This procedure applies to all the market complaint of products received from various
agencies such as Drug regulatory bodies, customers, field force, mail, etc., and adverse
reactions reported by doctors, licensing authorities.

3.0 RESPONSIBILITY
l Receiver: To receive the complaint from customer, licensing authorities, field force etc
and forward to Quality Assurance Head. The receiver may be marketing, commercial or
administration department.
1
 l Quality Assurance Head: Logging the complaint in complaint register, carry out the
investigation with the help of the respective department head, recommend corrective
action, send the reply to complaint.
l Head of Department: Help Quality Assurance head to carry out the investigation.
l Head Technical: To evaluate the Complaint investigation form and fix the responsibilities
of corrective action as recommended by Quality Assurance head by coordinating with
concerned individual.

4.0 ACCOUNTABILITY
QA Head

5.0 PROCEDURE
5.1 Product complaint is an information regarding any product defect, purity, labeling defects,
shortage or dissatisfaction of customer. Complaint can be from doctors, clinics, hospitals,
paramedics, pharmacies, dealer, government agencies, regulatory bodies, and customers.
It can be of two forms like verbal or written like mail, letter etc. The verbal complaint must be
documented by the receiver.
5.2 Complaints shows customer (consumer, prescriber, regulator and other stakeholder)
dissatisfaction about the quality of product and is an indicator of potential source of danger or
concern after distribution or sale.
5.3 All the concerned function like Marketing, Production, Quality control, Warehouse,
Distribution is involved in the investigation.
5.4 After receipt, all such complaint shall be sent to the Quality Assurance Head or designee
for investigation along with sample, if any. The receiver must acknowledge the complaint to
the sender.

2
5.5 The procedure consists of five parts, i.e.,

5.6 Complaint capture and processing:

l All complaints (written, verbal, telephonic or email) received directly are forwarded to
Quality Assurance Head or designee to initiate the investigation.
l The quality assurance department will file the complaint in register with reference
number: MC/YY/XXX
Where,
MC: Market complaint
YY: Current year, i.e., 22
XXX: Serial number,
For example, first complaint of 2022 year will have the number as MC/22/001.

3
 l Under the supervision of Quality Assurance Head or designee, the Officer/Chemist or
above of Quality Assurance Department will perform investigations by root cause.
5.7 Complaint management:
Observation and Investigation:
l The investigation is divided into two parts as documentation based and laboratory
based (Quality Control).
o Document based investigation consists of review of raw material testing reports,
review of batch records of complaint batch, In process Testing report, finished goods
testing reports, Stability review, etc.
o Laboratory based investigation is to reanalyze the complaint sample along with
control sample and review of data. In case of complaint sample is not received only
control sample is to be reanalyzed and data compared. Analyze the sample on same
specifications on which product was approved initially.
o Test parameters to be performed for the complaint sample are to be specified by
Quality Control head or designee. After completion of analysis, Quality Control Head
or designee has to send the report of analysis to Quality Assurance Head or designee
for further investigation.
l The complaint report should contain the following (Refer Annexure No. 01).
o Name and address of the complaint.
o Complaint number.
o Complaint received from and complaint received on.
o Product detail with product pack batch number manufacturing and expiry date.
o Detail of complaint with unique complaint number.
o Nature of complaint.
o Findings by Production/Quality Control/Quality Assurance.
o Conclusion
o Action to be taken
o CAPA
o Signatories with Department
l Quality Assurance Head or designee shall observe the complaint sample and control
sample and investigate nature of the complaint. Classify the complaint as

4
 Critical/Major/Minor depending upon nature of the complaint & inform
Director/Technical Head.
l Critical: Complaint regarding product stability/quality
On the consumption of the drug either the reaction is adverse or death of the patient or
it is ineffective. In this case stopping consumption or sale & recall shall be immediate.
l Major: Complaint regarding primary packing
Spots, sealing defects, etc., are major complaint.
l Minor: Complaint regarding secondary packing
Labeling defect, quantity less, number of tablets less are minor complaint.
l Quality Assurance Head or designee coordinates all the activities with Marketing
Department till the complaint is closed.
l In case of Critical Complaint: The batch shall be recalled (Refer Product Recall SOP) and
shall follow procedure for recall, handling and destruction.
o Quality Assurance Head or designee shall carry out the detailed investigation, check
the control sample of the complaint batch & should get re-analyzed with the
complaint sample (if received with complaint) by using a current version of
specification used for the routine testing of the product.
o Also the Quality Assurance Head or designee should recheck the BMR/BPR of that
batch & also preceding & succeeding batch to confirm that the operation of
manufacturing & the packing were performed as per SOPs & GMP norms as part of
investigation.
o Quality Assurance Head or designee has to consult (as per requirement) with
Technical Head/Marketing/Production for necessary investigation at their end.
Appropriate action is to be chosen from the following, depending on the nature of
the complaint.
l In case of Major Complaint: the batch shall be handled as per SOP for Handling of
Return Goods:
o If the Complaint are other than the product quality, the Quality Assurance Head or
designee sends a photocopy of the original complaint along with the sample ( if
available) to the respective department head for investigation.
o The Department Head check the respective record of the complaint batch, (Quality
Control Head or designee checks the Analytical report with raw data, Production
Head checks the BMR & BPR, etc.) as per the nature of the complaint & report to

5
 Quality Assurance Head or designee for necessary action if any discrepancies
observed.
l In case of Minor Complaint: Investigation and corrective action plan is indicated below:
o Key functionaries involved in the investigation of the complaint are : Quality
Assurance Head depending upon the nature of complaint, other Head of
Department (e.g., Production, Quality Control) are involved in the investigation and
corrective/preventive actions are planned and authorized by Quality Assurance Head
or designee. The concerned person from Production/Quality Control shall be
involved as part of preventive measures.
o Quality Assurance Head or designee follows up for the implementation of planned
corrective and preventive actions.
5.8 Corrective Action Plan:
l Quality Assurance Head or designee assesses the effectiveness of planned and
implemented corrective/preventive action. This is done to prevent the possibility of
repetition of the problem.
l All communication from factory to marketing shall be done by Quality Assurance Head
or designee.
l All discussion/communication with the customer are done through Marketing
Department Director. The Director & customer are informed about the status of
investigation and corrective action/observation.
5.9 After approval of CAPA, with the signatories of Production, Quality Control and Quality
Assurance, Quality Assurance Head or designee will hand over the report to Technical Head for
review.
5.10 Complaint resolution and closure:
l After receiving the analytical results and after performing the documentation-based
investigation, the Quality Assurance Head or designee will be able to conclude the
investigation. There are three possible conclusions as below;
o Confirmed Complaint: When both complaint and control samples showed Out of
Specification (OOS) results or when only complaint sample showed OOS results, the
complaint is classified as CONFIRMED. A missing tablet in Blister Strip will also be
concluded as confirmed, even when OOS is not initiated.
o Non-confirmed Complaint : When both complaint and control samples showed
result in compliance with specification or when only complaint sample showed OOS
results, that cannot be considered a single unexplained failing product. OOS results
in complaint sample can be attributed to misuse or mishandling, when the product

6
 was not stored under appropriate conditions. An example of non-confirmed sample
may be when the tablets of the complaint sample show a change in appearance,
which is characteristic of exposure to adverse conditions. This type of complaint is
classified as non-confirmed.
o Counterfeit/Tamper Suspicion: When the control sample is within specifications, but
the complaint sample is clearly OOS with no reason for that. This is an example of
counterfeit or tampered products, e.g., when the packaging material is different
from the original, color of product is completely different from the original.
l On the completion of the Investigation, the Quality Assurance Head or designee shall fill
the Complaint Register (Refer Annexure No. 02) containing the details like Complaint
received from/on complaint number, detail of product, Investigation completion date,
actions taken to avoid the complaints of same nature in future, status of complaints &
take the signature of the Quality Assurance Head or designee.
l Investigation shall be completed within 3 weeks.
l Simultaneously Quality Assurance Head or designee also fill the Product Complaint Form
(Refer Annexure No. 03) containing details like Product Name, Complaint received from,
Complaint received on, Reference Complaint number, Batch No., Manufacturing &
Expiry date, Complaint Quantity, Number of Cartons/Corrugated box, Nature of the
Complaint, Distribution record of the Complaint batch, Whether any complaint is
received for the same batch from any other customer, Analysis of Complaint Sample &
Control sample (if applicable), External & Internal Investigation details, Conclusion,
cause of Failure & necessary Corrective actions etc. to keep the track of the complaint
received for the individual product.
l The period for closing of the complaint depends upon the nature of the complaint, the
type of corrective and preventive action planned and the time required for the effective
implementation of the same.
l After reviewing the corrective actions and the results obtained, the Quality Assurance
Head or designee, Quality Control Head, Technical Head, Director and Marketing shall
decide on the closing of the complaint. The investigation report may be given to the
customer along with proposed action. The customer is requested to reply within one
month as regards to their satisfaction with proposed action. In case no communication
is received from the customer in the said time period the complaint shall be deemed
closed.
l Review of customer complaint is done once every six months by Quality Assurance
Head & Quality Assurance Officer/Chemist.
5.11 Retention of Complaint Test Samples:

7
 The complaint unused sample including packaging, at their labeled storage conditions will
be retained under custody of Quality Assurance Department for minimum of 90-day
period after the investigation. Apart from this, the retention of samples is initiated at
cases such as; Complaint referred to/received from Regulatory authorities, Samples
collected by Drugs Inspectors, Complaint forwarded by principal/Loan licensor and/or
received from customer, where the Complaint has expressed the intentions to take the
issue to the Regulatory authorities.

6.0 ABBREVIATIONS
Abbreviation Expanded form
SOP Standard Operating Procedure
GMP Good Manufacturing Practice
OOS Out of Specification
BMR Batch Manufacturing Record
BPR Batch Packing Record
GEN General

7.0 ANNEXURES
Annexure No. Title
01 Format for Complaint Report
02 Format for Complaint Register
03 Format for Product Complaint Form

8.0 SOP REFERENCES

1. WHO GMP Guidelines
2. SOP…

8
ANNEXURES:
Annex. No. 01 Format for Complaint Report

9
10
Annex. No. 02 Format for Complaint Register
11
Annex. No. 03 Format for Product Complaint Form

12
13
14
15