COMPLAINANT DRUG PRODUCT COMPLAINT REPORT

DETAILS
Name of Complainant Date

Section / Department Contact Number

PRODUCT DETAILS
Product Name Strength

Manufacturer

Batch No. Expiry Date Pack Size

TYPE OF CONCERNS
COMPLAINT

q Product Appearance q Packaging q Product Instability q Product Elegance

q Break in Cold Chain q Labelling q Package Condition q Breakage
q Odour q Shelf-Life q Product Efficacy
q Others (please state) q Safety
q Others (please state)

Description of Complaint:

ADDITIONAL
INFORMATION
Please answer these questions when appropriate.

Was seal on product broken when you received package? q Yes q No

Were other packages of same item examined? What was their condition?

Storage conditions (eg. Sunlight, heat, dampness, etc) and time period. Describe.

Complaint product submitted to DQCS? qYes q No

Submitted by

Designation and Chop:

DPCR / DQCS / ( )/(
)
(Complaint Number) / (Year)

FOR DQCS OFFICE USE ONLY

Products Description Correct q Yes q No

Sample Receipt q Yes q No

Description of Complaint (Additional Remarks)

ASSESSMENT OF COMPLAINT

q Complaint on Adverse Drug Reaction

Refer to Drug and Poison Information Section.
Reference Number Date

q Complaint not clearly defined

Investigate and make recommendation, submit to DPS
Decision maybe obtained from DGMS/PS through DPS

q Complaint on Product Quality

CLASSIFICATION OF COMPLAINT PERTAINING TO QUALITY (Please tick)

q Minor q Major q Critical

ACTION TAKEN (Reference: WP-DPC/DQCS/01)

Name of Reporter:

Signature of Reporter:

Date: