SUN MOON PHARMACEUTICALS PVT. LTD.

Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF MARKET COMPLAINTS
Department : Quality Assurance SOP No. : SOP/QA/005
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 1 of 7
Prepared By Reviewed By Approved By
Sign. with
Date.

1.0 OBJECTIVE:
To lay down the procedure for handling of market complaints from customersat Sum moon
Pharmaceuticals Pvt. Ltd.

2.0 SCOPE:

This procedure is applicable for customer complaint/market complaintreceived from the domestic or
international customers related tothe product manufactured by at Sum moon Pharmaceuticals Pvt.
Ltd.

3.0 RESPONSIBILITY:

Marketing Department : Forward the complaint to QA

Quality Assurance : Log the customer complaint allocate the customer complaint number
And CAPA number
: Distribute the complaint to respective department investigation of
root cause, investigation report Preparation maintaining the records.
: Implementation of CAPA.
QC Head/Designee : Analysis of sample, if complaint relate to quality.
Production HOD/Designee : Identify the root cause, give the CAPA
Manager - QA / Designee : suggestion of CAPA and monitor the implementation

4.0 PRECAUTIONS:

NA

5.0 PROCEDURE:

5.1 Receipt of customer Complaint:

5.1.1 After receiving the complaint through telephone, written, mail, fax to marketing/
sales department shall segregate the complaint as commercial complaint or quality
complaint.
5.1.2 If complaints are regarding to the commercial matter, sales person shall handle the
complaint jointly with QA.
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF MARKET COMPLAINTS
Department : Quality Assurance SOP No. : SOP/QA/005
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 2 of 7
Prepared By Reviewed By Approved By
Sign. with
Date.

5.2 QA shall enter the market complaint in the Market complaint register with details as per the
Annexure-I.

5.3 QA shall initiate the Customer Complaint form as Annexure-II, allocate the Complaint
number with sign and date.

5.4 The Customer complaint number shall be assign as follows,

CCN- YY- XXX.

Where,
CCN - denotes the customer complaint number.
YY - denotes the current year
XXX - denotes the sequential number starting from 001.
Example:CCN-20-001

5.5 The QA Designee shall define the nature of complaint in the categories, such as Quality,
Quantity, Packing, labeling and sealing related or Document related.

5.6 QA shall define the category of complaint as major minor or critical.

Critical:

A defect which can have a significant impact on product quality, safety and efficacy and
likely to have serious harmful effect or potential hazard on the patient (e.g. Product mix up,
label mix up, adverse drug reaction) and / or no therapeutic effect.

For Example: Assay failure / Microbial Proliferation / Wrong expiry date that can lead to
consumption of product beyond actual expiry, absence of break line which can result in
difficulty in breaking the tablet in two equal halves like to like.

Major:

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF MARKET COMPLAINTS
Department : Quality Assurance SOP No. : SOP/QA/005
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 3 of 7
Prepared By Reviewed By Approved By
Sign. with
Date.

A defect that can have an impact on product but unlikely to have adverse impact on the
patient.

For Example: Physical description of the product not as per the specifications (non-critical
parameter).

Minor:

Any defect, which has no impact on the quality, safety and efficacy of product.

For Example: Short Supplies / wrong price etc.

5.7 Complaints of serious nature (critical category) such as adverse reaction, potential hazard or
risk to the patient, should call for immediate action.

5.8 Investigation

5.8.1 QA department shall investigate the complaint jointly with related department
depending, as per the nature of the complaint and by forming the team.

5.8.2 The investigation shall be carried out by team of representatives from Quality
Control, QA and Production. The investigation shall involve (but not limited to)
examination of reserve sample, Batch Production Records, In-process testing records,
Analytical Reports, Stability Data (if required) and analysis of complaint sample (if
applicable).

5.8.3 If complaint regarding quality start the investigation with QC and also include the
production department.

5.8.4 Further actions shall be initiated as per recommendations in investigation report.

5.9 Product quality related complaints:

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF MARKET COMPLAINTS
Department : Quality Assurance SOP No. : SOP/QA/005
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 4 of 7
Prepared By Reviewed By Approved By
Sign. with
Date.

5.9.1 Product related complaints shall be investigated as,Complaint regarding physical

parameters shall investigated by the QA department jointly with production
department.
5.9.2 BMR with In-process results shall be evaluated during investigation.

5.9.3 Manufacturing facility used raw materials, calibration status maintained, critical
parameters shall be investigated.

5.9.4 Complaints regarding difference in analysis shall investigate by QA along with the
QC.

5.9.5 QC shall conduct the re-analysis of controlled sample.

5.9.6 If controlled sample passes, QA shall go through the BMRs of that particular batch.

5.9.7 QA shall arrange the joint analysis with the customer at a site or customer venue, if
require.

5.9.8 Re-analysis report generated and shall be documented.

5.9.9 If joint analysis is not possible then QA shall arrange the analysis at external
laboratories agreed by both parties.

5.9.10 If controlled sample fails, OOS shall be raised and investigation shall be done
accordingly the OOS SOP.

5.10 Packing Material Related complaints:

5.10.1 QA & Production department shall jointly investigate the complaint.

5.10.2 During investigation document evidence in the consignment check form shall be
reviewed.
5.10.3 In the investigation, identify the damage has happened before or after transportation.
5.11 Documents Related complaints:

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF MARKET COMPLAINTS
Department : Quality Assurance SOP No. : SOP/QA/005
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 5 of 7
Prepared By Reviewed By Approved By
Sign. with
Date.

5.11.1 QA along with the QC shall jointly investigate the deficiency in the document
supplied to customer. E.g.: COA, Specification.

5.11.2 As per the complaint QA shall identify the requirements and fulfill it.

5.12 Reporting & Follow-up:

5.12.1 Head QA shall send the suitable reply to the marketing department.

Note: If required QA can directly communicate and reply to the customer with a copy to
marketing department.

5.12.2 If required, QA should initiate trials in R & D department, based on that changes in
the process or system should be done after proper validation and handled as per
Change Management Procedure.

5.12.3 If the conclusion of the investigation requires product recall, then the Head QA in
consultation with Plant Head, Executive Director/Managing Director shall take the
decision for the same. The product shall be recalled as per the Product Recall
Procedure in effect.

5.12.4 After complete investigation, the complaint sample should be destroyed under the
supervision of Head QA.

5.12.5 The complaint shall be closed if no further query has been raised by the complainant
within 30 working days from the date of reply and further 20 days after reminder for
reply. The complaint file will be closed with necessary remarks on it and archived in
QA.

5.12.6 All details of complaint shall be recorded in complaint file at the site QA along with
the investigation records.
5.12.7 If in the investigation complaint is found is not genuine then provide the proper
justification for the same along with the supporting documents.
5.12.8 If additional information is required by the customer QA shall provide the
information with the evidence.
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF MARKET COMPLAINTS
Department : Quality Assurance SOP No. : SOP/QA/005
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 6 of 7
Prepared By Reviewed By Approved By
Sign. with
Date.

5.12.9 QA shall send the closed complaints with the supporting document to sales
department.

5.12.10 Market complaint shall be evaluated, reviewed and summarized in the Annual
Product Review.

5.12.11 Sales department shall share feedback form customer with QA after receipt of
the closed complaint.

6.0 LIST OF ANNEXURES / ATTACHMENTS:

ANNEXURE – 1 Market Complaint Log SOP/QA/005-F01.00

ANNEXURE – 2 Market Complaint Form SOP/QA/005-F02.00

7.0 ABBREVIATIONS:

SOP Standard operating procedure

No. Number
NA Not Applicable
REV. Revision
R&D Research and development
ICH International Conference on Harmonisation

8.0 REFERENCE:

8.1 ICHQ7

9.0 SOP DISTRIBUTION:

Name of Department Department Code

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE:HANDLING OF MARKET COMPLAINTS
Department : Quality Assurance SOP No. : SOP/QA/005
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 7 of 7
Prepared By Reviewed By Approved By
Sign. with
Date.

Quality Assurance QA
Production PD
Quality Control QC
Microbiology MB
Maintenance & Engineering MD
Human Resources HR
Warehouse WH
Research & Development RD
10.0 REVISION AND HISTORY:

REV. NO. REASON FOR REVISION

00 New SOP

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.