CHAPTER 0 2

PERSONNEL

REF:

WHO 32

YES

NO

1

Sections 10.1,

10.4, 10.11,

10.23.

Are there Standard Operating Procedures (SOP) related to personnel, including professional qualification, training?

2

Section 10.3.

Is there an updated organization chart of the company? Attach copy

3

Section

10.3

Is there a description of the responsibilities and functions of production and quality

control personnel?

4

Section 10.6.

Are the responsibilities of production and quality control personnel independent of each other?

5

Section 10.7

Are there trained personnel for the supervision of production and quality control activities?

6

Section 10.12

Is there a program for training new employees on GMP, including specific training appropriate to the duties assigned to them?

6.1

Section 10.4,

10.12.

Is there a program for continuous training on GMP for all staff, including specific training appropriate to the duties assigned to them?

6.2

Section 10.12

Are records kept?

7

Section 10.15,

10.23

Is there a SOP dealing with the use of proper clothing for other persons who enter production areas (technical service/maintenance, cleaning personnel, quality control inspectors, quality assurance inspectors, and visitors)?

REF:

WHO 32

PERSONNEL

YES

NO

8

Section 10.23

Are there visible written instructions and/or diagrams for the right use of clothing in the change rooms and other areas where they are required?

9

Section 10.16

Are the personnel required to undergo a medical examination prior to being employed (including sensitivity test to beta-lactam substances, if required)?

10

Section 10.1

Are the personnel subject to periodic medical examinations, at least once a year?

10.1

Sections 10.18, 10.19.

Are the personnel required to report health problems?

11

Section 10.16,

10.18

Is there a procedure to prevent any person who has an apparent illness from entering areas in which they may adversely affect the quality of the product or affect their own health?

12

Section 10.22

Is smoking, eating, drinking and chewing prohibited in production, storage and laboratory areas?

13

Section 10.17

Are the personnel instructed to wash their hands before entering production areas?

13.1

Section 10.17

Are there signs posted outlining mandatory hand washing before exiting, in change rooms and washrooms?

14

Section 10.21

Are the personnel using the appropriate uniform for the specified area?

12.1

Section 11.12

Are the uniforms clean and in good condition?