QAS-030 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 422

Key performance indicator: MARKET COMPLAINTS (VALID/INVALID) AND RECALLS

Report for the month of

Kindly provide the required information as per the following data sheet up to the 5th day of each
month.
Additional sheets may be used for details wherever necessary.

response/
corrective
measure 5

Product
name 1

nature of
complaint 3

complaint
from 4

valid/
invalid 6 s/no. batch no. 2

Information provided by:

Name and signature:

Date:

Note:

1. Name of the product for which complaint is received.

2. Batch number of the product.

3. Nature of complaint, for example, the description of complaint will be entered in this
column.

4. In this column, the name of complainant will be entered, for example, if it is from a cus-
tomer, from health regulatory laboratory, or from a pharmacy store.

5. Details of the corrective measures taken.

6. Conclusion, if the complaint was genuine or not.