HANDLING OF MARKET COMPLAINTS, COMPLAINT INFORMATION FORM AND MARKET COMPLAINT INVESTIGATION REPORT

XXX PHARMA LIMITED

PUNE – MH.

QUALITY ASSURANCE

 DEPARTMENT

STANDARD OPERATING PROCEDURE

REF. NO.

:

SOP/QA/00X-1

SUPERSEDES

:

SOP/QA/00X-0

EFFECTIVE DATE

REVIEW DATE

PAGE NO.

1 OF 3

TITLE: Handling Of MARKET Complaints.

Prepared By

Verified By

Authorized By

Signature:

Date:

Name:

Designation:

QA Officer

Manager QA

DGM-QA

1.0

OBJECTIVE:

To lay down the procedure to investigate, document, respond and review the market complaints received.

2.0

SCOPE:

This procedure is applicable to all the market complaints received.

2.0

RESPONSIBILITY:

Person Performing:

DGM QA / HOD QA / Concerned HOD’s

Person Monitoring:

DGM QA

4.0

PROCEDURE:

4.1

All the complaints (oral or written), regardless of their origin, shall be forwarded to the Quality Assurance department along with sample specimens, if any. 

4.2

On receipt of the complaint, QA shall make an entry on the Market Complaint Log Book (refer Annexure – SOP/QA/007/1) and assign a unique reference number as mentioned below-

MCYYXXX.

Where

MC

: Market Complaint

YY

: Year (eg. 07, 08, etc.)

XXX

: Sequential number in increasing order ie. 001, 002, etc.

Start new sequential numbering at the start of the New Year.

4.3

If any complaint sample is received along with the complaint, label the same with the complaint number.

XXX PHARMA LIMITED

PUNE – MH.

QUALITY ASSURANCE

 DEPARTMENT

STANDARD OPERATING PROCEDURE

REF. NO.

:

SOP/QA/00X-1

SUPERSEDES

:

SOP/QA/00X-0

EFFECTIVE DATE

REVIEW DATE

PAGE NO.

2 OF 3

TITLE: Handling Of MARKET Complaints.

4.4

QA shall fill the Complaint Information Form (refer Annexure – SOP/QA/007/2) in order to document all the available information regarding the complaint and forward the same to DGM QA.

4.5

Investigation shall be conducted as per the Market Complaint Investigation Report (refer Annexure – SOP/QA/00X/3) form.

4.6

The DGM QA shall examine the seriousness of the complaint and make its classification as A-type, B-type or C-type.

4.7

A-Type Complaints:Critical complaints in which product is required to be withdrawn from the market. Such as

a) Adverse Drug Reaction.

b) Major Health Hazard causing permanent deficiency or death.

c) Purity & Safety.

d) Potency.

e) Product Stability.

4.7.1

DGM QA personally handles such complaints. He shall take necessary actions rapidly by involving all the concerned HOD’s to ensure speedy withdrawal of the product from the market.  A-type of complaints is handled within 24 hours from the time of receipt.

4.8

B-Type Complaints:Major complaints such as

a) Problem with primary packaging of the product.

b) Chemical / Physical attributes of the product.

c) Extraneous contamination, mix-ups, etc.

4.9

C-Type Complaints:Minor complaints such as

a) Problem related to labeling / coding of batch details.

b) Shortages.

c) Secondary packaging material problem, etc.

4.10

B-Type and C-Type complaints shall be handled by HOD QA & concerned HOD and investigated as per the Market Complaint Investigation Report (refer Annexure – SOP/QA/00X/3) form.

4.11

Investigation shall be completed within a week from the date of receipt of the market complaint. 

4.12

The investigation report shall be handed over to DGM QA.

XXX PHARMA LIMITED

PUNE – MH.

QUALITY ASSURANCE

 DEPARTMENT

STANDARD OPERATING PROCEDURE

REF. NO.

:

SOP/QA/00X-1

SUPERSEDES

:

SOP/QA/00X-0

EFFECTIVE DATE

REVIEW DATE

PAGE NO.

3 OF 3

TITLE: Handling Of MARKET Complaints.

4.13

DGM QA shall discuss with the HOD QA and other concerned HODs and finalize the corrective and preventive action plan with responsibility and time frame for the action to be taken so as to avoid its recurrence in future.

4.14

DGM QA shall prepare a suitable reply to the complainant and send by Fax or courier along with instructions of the replacement of goods if any.

4.15

HOD QA shall make the necessary entries on the Market Complaint Log.

4.16

If no further communications are received from marketing department or customer for a period of 3 months after the response are sent, such complaints are considered to be “Closed” to the satisfaction of the customer.

NOTE: Incase if the feedback is received after the complaint is closed as mentioned above the said compliant shall be reopened until closed again to the satisfaction of the complainant.

5.0

ABBREVIATION:

SOP

:

Standard Operating Procedure

QA

:

Quality Assurance

DGM

:

Deputy General Manager

HOD

:

Head of Department

6.0

ANNEXURE:

Annexure - SOP/QA/ 007/1    – ‘Market Complaint Log Book’.

Annexure – SOP/QA/007/2    – ‘Complaint Information Form’.

Annexure – SOP/QA/007/3    – ‘Market Complaint Investigation Report’.

7.0

REFERENCE:

Nil.

XXX PHARMA LTD.

COMPLAINT INFORMATION FORM

Ref. No.

:

Supersedes

:

Effective Date

:

Page No.

: 1 of 2

Complaint No.:

Date:

Details of Complaint:

1.

Date of Receipt of Complaint

:

2.

Name of Product

:

3.

Batch Number

:

4.

Manufacturing Date

:

5.

Expiry Date

:

6.

Complaint Received From

:

7.

Whether Complaint is written / E-mail / Oral / Telephonically

:

8.

Complaint is related to Product Quality / Short Supply / Packaging / Statutory / Other (Specify)

:

9.

Brief Description of Complaint

:

XXX PHARMA LTD.

COMPLAINT INFORMATION FORM

Ref. No.      

:

Supersedes

:

Effective Date     

:

Page No.        

: 2 of 2

10.

Enclose defective sample received along with complaint

:

YES / NO

11.

Observation when defective sample was received.

Whether the pack was intact / sealed

:

12.

Whether Complaint involves any adverse Medical Reaction (if yes)

:

YES / NO

Whether Doctor / Patient was contacted, if Yes, their observation / comments

:

YES / NO

13

Whether sales representative has interacted with complainant

[If Yes, His / Her Comments]

:

YES / NO

14.

Whether Investigation required

[Give reasons if no Investigation required]

:

Quality Assurance

(Sign / Date)

XXX PHARMA LTD.

MARKET COMPLAINT INVESTIGATION REPORT

Ref. No.    

:

Supersedes

:

Effective Date 

:

Page No.

: 1 of 2

Complaint No.  :

Date :

Name of product :

B. No.:

Details of Investigation:

1.

Person(s) designated for Investigation

Name

:

Department

:

2.

Control Sample Observation and Re-Analysis Data in view of Complaint.

[Attach separate sheet, If required]

:

3.

Batch Production Record review

Analytical data review

(Write brief description of observation)

:

4.

Whether the reanalysis data of retention sample of subject batch complies with the specification.

: