CHAPTER 7

PRODUCTS RECALL

Ref.

32º WHO

YES

NO

1

Sections

7.1 and

7.3.

Is there an operating procedure that establishes a system to recall products from the market, if necessary?

2

Section

7.2

Is there a responsible person (independent from the marketing department) designated by or in accordance with the qualified person responsible for the coordination and execution of the recall procedure?

3

Section

7.2

Is Quality control/Quality assurance/Regulatory Affairs notified of undertaken recall operations?

4

Section

7.4.

Does the procedure indicate the mandatory requirement of notifying the Health Authority immediately in the event that the cause is for health

reasons?

5

Section

7.4

In the case of having distributed products to other countries, is the Health Authority of the recipient country and the recipient of these products informed immediately?

6

Section

7.5.

Are distribution records available for a prompt recall of products from the

market?

7

Section

7.5.

Do those distribution records contain information that allows for the traceability and determination of the receivers of that distribution?

8

Section

7.6.

Are there reports about all products recalled from the market, as well as the cause, destination, destruction dates and final reconciliation of quantities?

Ref.

32º WHO

PRODUCTS RECALL

YES

NO

9

Section

7.6.

Are those reports attached to the product lot record?

10

Section

13.29

Are the recalled products identified as such?

11

Section

13.29

Are these products maintained segregated and orderly in an access restricted

area?